Trial Outcomes & Findings for Back on Track to Healthy Living Study (NCT NCT03687762)

NCT ID: NCT03687762

Last Updated: 2025-03-13

Results Overview

Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed for a total raw score from 5-25. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 397 participants
• Primary outcome timeframe: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
• Results posted on: 2025-03-13

Participant Flow

Potential participants were identified primarily via coding lists (i.e., sections of medical charts) of UW Medicine patients who had a low back pain diagnosis in their electronic medical record. Other recruitment strategies included the use of the UW Rehabilitation Medicine departmental research participant pool, posted flyers in pain and rehabilitation clinics, clinician referrals, news releases with the UW Newsroom, and a variety of national recruitment strategies.

Of the 1081 participants screened for eligibility, 100 could not be contacted, 78 declined participation, 494 did not meet screening criteria, and 12 were not recruited as the recruitment period had concluded. A total of 397 were then enrolled and commenced the baseline assessments. Of those, 302 completed at least 10/14 EMA surveys and also returned the activity monitor with overall wear compliance at 70% of time or higher, and these participants were then randomized to condition.

Participant milestones

Measure	Cognitive Therapy (CT) Condition Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Overall Study STARTED	99	102	101
Overall Study COMPLETED	86	88	89
Overall Study NOT COMPLETED	13	14	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Back on Track to Healthy Living Study

Baseline characteristics by cohort

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.	Total n=302 Participants Total of all reporting groups
Age, Continuous	46.9 years STANDARD_DEVIATION 14.7 • n=5 Participants	49.4 years STANDARD_DEVIATION 14.7 • n=7 Participants	51.0 years STANDARD_DEVIATION 12.2 • n=5 Participants	49.1 years STANDARD_DEVIATION 14.0 • n=4 Participants
Sex/Gender, Customized Woman	78 participants n=5 Participants	76 participants n=7 Participants	78 participants n=5 Participants	232 participants n=4 Participants
Sex/Gender, Customized Man	18 participants n=5 Participants	21 participants n=7 Participants	18 participants n=5 Participants	57 participants n=4 Participants
Sex/Gender, Customized Transgender	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Sex/Gender, Customized Non-binary	2 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants
Sex/Gender, Customized Other/Unspecified	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	8 participants n=4 Participants
Race/Ethnicity, Customized White	83 participants n=5 Participants	72 participants n=7 Participants	75 participants n=5 Participants	230 participants n=4 Participants
Race/Ethnicity, Customized Black/African American	4 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	20 participants n=4 Participants
Race/Ethnicity, Customized Latinx	3 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	19 participants n=4 Participants
Race/Ethnicity, Customized Other/Unspecified	9 participants n=5 Participants	14 participants n=7 Participants	10 participants n=5 Participants	33 participants n=4 Participants
Region of Enrollment United States	99 participants n=5 Participants	102 participants n=7 Participants	101 participants n=5 Participants	302 participants n=4 Participants
PROMIS Pain Interference	66.6 T-score STANDARD_DEVIATION 5.2 • n=5 Participants	64.9 T-score STANDARD_DEVIATION 5.4 • n=7 Participants	66.4 T-score STANDARD_DEVIATION 5.9 • n=5 Participants	65.98 T-score STANDARD_DEVIATION 5.5 • n=4 Participants

PRIMARY outcome

Timeframe: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported

Population: Intent to treat sample.

Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed for a total raw score from 5-25. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Pain Interference (Micro-level Change) Early treatment slope (assessed via EMA)	-1.34 scores on a scale Standard Deviation 9.93	-1.03 scores on a scale Standard Deviation 5.68	-0.50 scores on a scale Standard Deviation 4.73
Change in Pain Interference (Micro-level Change) Late treatment slope (assessed via EMA)	-0.73 scores on a scale Standard Deviation 6.67	0.01 scores on a scale Standard Deviation 6.05	-0.73 scores on a scale Standard Deviation 6.29

PRIMARY outcome

Timeframe: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

Population: Intent to treat sample.

Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed for a total raw score from 5-25. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Pain Interference (Macro-level Change) Change from pre- to post-treatment (assessed over phone)	-5.0 change score on a scale Standard Deviation 5.0	-4.5 change score on a scale Standard Deviation 6.4	-5.6 change score on a scale Standard Deviation 5.6
Change in Pain Interference (Macro-level Change) Change from pre- to 3 months post-treatment (assessed over phone)	-4.7 change score on a scale Standard Deviation 5.5	-3.4 change score on a scale Standard Deviation 6.2	-5.6 change score on a scale Standard Deviation 6.2
Change in Pain Interference (Macro-level Change) Change from pre- to 6 months post-treatment (assessed over phone)	-4.1 change score on a scale Standard Deviation 6.0	-3.4 change score on a scale Standard Deviation 6.2	-5.6 change score on a scale Standard Deviation 7.0

SECONDARY outcome

Timeframe: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported

Population: Intent to treat

Change in pain intensity of chronic pain in general will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Pain Intensity (Micro-level) Late treatment slope (assessed via EMA)	-0.17 scores on a scale Standard Deviation 1.26	0.09 scores on a scale Standard Deviation 1.74	-0.04 scores on a scale Standard Deviation 1.79
Change in Pain Intensity (Micro-level) Early treatment slope (assessed via EMA)	-0.40 scores on a scale Standard Deviation 2.00	-0.26 scores on a scale Standard Deviation 1.67	-0.23 scores on a scale Standard Deviation 1.18

SECONDARY outcome

Timeframe: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported

Population: Intent to treat

Change in mood will be assessed using the Positive and Negative Affect Schedule (PANAS). Total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Mood (Micro-level) Positive Affect, early treatment slope (assessed via EMA)	0.13 scores on a scale Standard Deviation 1.01	0.06 scores on a scale Standard Deviation 0.89	0.01 scores on a scale Standard Deviation 0.71
Change in Mood (Micro-level) Negative Affect, early treatment slope (assessed via EMA)	-0.19 scores on a scale Standard Deviation 0.82	-0.08 scores on a scale Standard Deviation 0.96	-0.13 scores on a scale Standard Deviation 0.73
Change in Mood (Micro-level) Positive Affect, late treatment slope (assessed via EMA)	0.08 scores on a scale Standard Deviation 0.67	0.08 scores on a scale Standard Deviation 0.60	0.16 scores on a scale Standard Deviation 0.62
Change in Mood (Micro-level) Negative Affect, late treatment slope (assessed via EMA)	-0.14 scores on a scale Standard Deviation 0.73	0.05 scores on a scale Standard Deviation 0.70	0.11 scores on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

Population: Intent to treat

Change in extent of physical function will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form-4A. Responses from each item will be summed to form a total raw score ranging from 4-20. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels (i.e., better) physical function. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Physical Function Change from pre- to post-treatment (assessed over phone)	1.6 change score on a scale Standard Deviation 3.6	1.1 change score on a scale Standard Deviation 3.4	2.1 change score on a scale Standard Deviation 3.8
Change in Physical Function Change from pre- to 3 months post-treatment (assessed over phone)	2.0 change score on a scale Standard Deviation 4.3	1.2 change score on a scale Standard Deviation 4.0	2.7 change score on a scale Standard Deviation 4.2
Change in Physical Function Change from pre- to 6 months post-treatment (assessed over phone)	1.9 change score on a scale Standard Deviation 5.6	1.3 change score on a scale Standard Deviation 5.2	2.5 change score on a scale Standard Deviation 4.8

SECONDARY outcome

Timeframe: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

Population: Intent to treat

Change in sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form-4A. Responses from each item will be summed to form a total raw score ranging from 4-20. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported sleep disturbance. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Sleep Quality Change from pre- to post-treatment (assessed over phone)	-3.5 change score on a scale Standard Deviation 7.1	-1.7 change score on a scale Standard Deviation 6.2	-4.9 change score on a scale Standard Deviation 6.8
Change in Sleep Quality Change from pre- to 3 months post-treatment (assessed over phone)	-3.5 change score on a scale Standard Deviation 6.6	-2.1 change score on a scale Standard Deviation 7.1	-4.3 change score on a scale Standard Deviation 8.3
Change in Sleep Quality Change from pre- to 6 months post-treatment (assessed over phone)	-4.0 change score on a scale Standard Deviation 7.3	-3.4 change score on a scale Standard Deviation 7.6	-4.9 change score on a scale Standard Deviation 9.4

SECONDARY outcome

Timeframe: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

Population: Intent to treat

Change in depression will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form-4A. Responses from each item will be summed to form a total raw score ranging from 4-20. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher self-reported levels of depression. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Depression Severity Change from pre- to post-treatment (assessed over phone)	-3.3 change score on a scale Standard Deviation 7.0	-2.6 change score on a scale Standard Deviation 7.8	-2.6 change score on a scale Standard Deviation 6.7
Change in Depression Severity Change from pre- to 3 months post-treatment (assessed over phone)	-2.4 change score on a scale Standard Deviation 6.9	-2.3 change score on a scale Standard Deviation 8.2	-2.0 change score on a scale Standard Deviation 6.4
Change in Depression Severity Change from pre- to 6 months post-treatment (assessed over phone)	-2.3 change score on a scale Standard Deviation 7.7	-2.2 change score on a scale Standard Deviation 9.4	-1.9 change score on a scale Standard Deviation 7.4

SECONDARY outcome

Timeframe: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

Population: Intent to treat

Change in anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form-4A. Responses from each item will be summed to form a total raw score ranging from 4-20. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher self-reported levels of anxiety. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Anxiety Severity Change from pre- to post-treatment (assessed over phone)	-2.2 change score on a scale Standard Deviation 7.1	-2.1 change score on a scale Standard Deviation 7.9	-1.5 change score on a scale Standard Deviation 7.2
Change in Anxiety Severity Change from pre- to 3 months post-treatment (assessed over phone)	-1.4 change score on a scale Standard Deviation 8.6	-2.2 change score on a scale Standard Deviation 9.0	-0.4 change score on a scale Standard Deviation 8.3
Change in Anxiety Severity Change from pre- to 6 months post-treatment (assessed over phone)	-1.8 change score on a scale Standard Deviation 8.4	-1.4 change score on a scale Standard Deviation 9.4	0.1 change score on a scale Standard Deviation 8.9

SECONDARY outcome

Timeframe: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

Population: Intent to treat

Change in opioid medication use will be assessed by asking participants to report use of opioid medications within the past 7 days. Participants will be asked to report medication name, quantity per dose (e.g., 50 mg), and number of medication doses taken in the past week. Researchers will calculate a morphine equivalent dose (MED) for opioid medications. Due to violation of assumptions of normality, the MED data was transformed into a categorical variable (no prescription, increase, decrease, no change).

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=85 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=87 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=89 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Medication Use No prescription pre or post-treatment	58 Participants	61 Participants	58 Participants
Change in Medication Use No prescription pre or 3 months post-treatment	53 Participants	53 Participants	49 Participants
Change in Medication Use No prescription pre or 6 months post-treatment	50 Participants	48 Participants	51 Participants
Change in Medication Use Increase from pre- to post-treatment	9 Participants	10 Participants	6 Participants
Change in Medication Use Increase from pre- to 3 months post-treatment	13 Participants	12 Participants	9 Participants
Change in Medication Use Increase from pre- to 6 months post-treatment	11 Participants	13 Participants	10 Participants
Change in Medication Use Decrease from pre- to post-treatment	6 Participants	13 Participants	12 Participants
Change in Medication Use Decrease from pre- to 3 months post-treatment	8 Participants	10 Participants	14 Participants
Change in Medication Use Decrease from pre- to 6 months post-treatment	10 Participants	10 Participants	10 Participants
Change in Medication Use No change from pre- to post-treatment	12 Participants	3 Participants	13 Participants
Change in Medication Use No change from pre- to 3 months post-treatment	7 Participants	3 Participants	7 Participants
Change in Medication Use No change from pre- to 6 months post-treatment	7 Participants	1 Participants	9 Participants

SECONDARY outcome

Timeframe: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

Population: Intent to treat

Change in pain intensity of chronic pain in general will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Pain Intensity (Macro-level) Change from pre- to post-treatment (assessed over phone)	-1.0 change score on a scale Standard Deviation 1.8	-1.2 change score on a scale Standard Deviation 2.1	-1.3 change score on a scale Standard Deviation 1.9
Change in Pain Intensity (Macro-level) Change from pre- to 3 months post-treatment (assessed over phone)	-0.9 change score on a scale Standard Deviation 1.7	-0.8 change score on a scale Standard Deviation 1.9	-1.4 change score on a scale Standard Deviation 2.2
Change in Pain Intensity (Macro-level) Change from pre- to 6 months post-treatment (assessed over phone)	-1.0 change score on a scale Standard Deviation 1.9	-1.0 change score on a scale Standard Deviation 2.0	-1.1 change score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

Population: Intent to treat

Change in mood will be assessed using the Positive and Negative Affect Schedule (PANAS). Responses from the positive affect items will be summed for a total positive score ranging from 5-25 while responses from the negative affect items will be separately summed for a total negative score ranging from 5-25. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Mood (Macro-level) Positive Affect, change from pre- to post-treatment (assessed over phone)	1.5 change score on a scale Standard Deviation 3.5	1.3 change score on a scale Standard Deviation 3.0	1.6 change score on a scale Standard Deviation 3.9
Change in Mood (Macro-level) Negative Affect, change from pre- to post-treatment (assessed over phone)	-1.2 change score on a scale Standard Deviation 3.2	-0.8 change score on a scale Standard Deviation 4.1	-1.3 change score on a scale Standard Deviation 3.3
Change in Mood (Macro-level) Positive Affect, change from pre- to 3 months post-treatment (assessed over phone)	1.4 change score on a scale Standard Deviation 3.6	0.4 change score on a scale Standard Deviation 3.4	1.0 change score on a scale Standard Deviation 4.1
Change in Mood (Macro-level) Negative Affect, change from pre- to 3 months post-treatment (assessed over phone)	-0.8 change score on a scale Standard Deviation 3.4	-0.5 change score on a scale Standard Deviation 3.6	-1.0 change score on a scale Standard Deviation 3.0
Change in Mood (Macro-level) Positive Affect, change from pre- to 6 months post-treatment (assessed over phone)	0.7 change score on a scale Standard Deviation 3.9	1.1 change score on a scale Standard Deviation 3.2	0.8 change score on a scale Standard Deviation 4.2
Change in Mood (Macro-level) Negative Affect, change from pre- to 6 months post-treatment (assessed over phone)	-0.7 change score on a scale Standard Deviation 3.8	-0.5 change score on a scale Standard Deviation 4.2	-1.0 change score on a scale Standard Deviation 3.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported

Population: Intent to treat

Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Micro-level) Late treatment slope (assessed via EMA)	-1.55 scores on a scale Standard Deviation 7.69	-0.27 scores on a scale Standard Deviation 7.34	-0.07 scores on a scale Standard Deviation 5.65
Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Micro-level) Early treatment slope (assessed via EMA)	-2.3 scores on a scale Standard Deviation 7.96	-1.30 scores on a scale Standard Deviation 7.72	-0.71 scores on a scale Standard Deviation 5.96

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported

Population: Intent to treat

Change in non-judgment will be measured with items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. When assessed via phone, the full 6-item scale will be used while only four items are used in the EMA. Items will be averaged for a mean score from 0-4. Higher mean PCPQ scores indicate higher frequencies of using the adaptive cognitive process of non-judgment in responding to pain. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Non-Judgment (i.e., Cognitive Process Mechanism; Micro-level) Early treatment slope (assessed via EMA)	0.31 scores on a scale Standard Deviation 0.77	0.18 scores on a scale Standard Deviation 0.84	0.10 scores on a scale Standard Deviation 0.72
Change in Non-Judgment (i.e., Cognitive Process Mechanism; Micro-level) Late treatment slope (assessed via EMA)	0.10 scores on a scale Standard Deviation 0.73	0.10 scores on a scale Standard Deviation 0.79	0.05 scores on a scale Standard Deviation 0.68

OTHER_PRE_SPECIFIED outcome

Timeframe: Worn daily during 4-week treatment period, early treatment (baseline-2 weeks) and late treatment (2-4 weeks) reported

Population: Intent to treat

Change in activity level will be measured by an actigraphy device worn by the participant measuring activity level. In this study, we used the vector magnitude average counts variable, which is the average of all activity counts recorded per minute that the device was worn (i.e., it removes non-wear times from analysis). Higher activity counts indicate higher intensity activities that day; the minimum possible score (theoretically is zero, with no theoretical maximum score). Slopes were calculated by computing the linear regression slopes for the Actigraph collected activity counts.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Activity Level (Actigraph, Vector Magnitude Average Counts) Early Treatment (at baseline to 2 weeks)	-148064.01 activity counts Standard Deviation 955190.23	-2380.15 activity counts Standard Deviation 569389.47	-82046.98 activity counts Standard Deviation 430455.44
Change in Activity Level (Actigraph, Vector Magnitude Average Counts) Late Treatment (at 2 weeks to 4 weeks)	26392.50 activity counts Standard Deviation 962819.17	-38711.02 activity counts Standard Deviation 980492.69	64274.53 activity counts Standard Deviation 573771.91

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

Population: Intent to treat

Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) Change from pre- to post-treatment (assessed over phone)	-7.12 change score on a scale Standard Deviation 8.45	-6.91 change score on a scale Standard Deviation 9.85	-8.28 change score on a scale Standard Deviation 8.12
Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) Change from pre- to 3 months post-treatment (assessed over phone)	-6.72 change score on a scale Standard Deviation 9.32	-4.70 change score on a scale Standard Deviation 8.76	-7.97 change score on a scale Standard Deviation 9.48
Change in Pain Catastrophizing (i.e., Cognitive Content Mechanism; Macro-level) Change from pre- to 6 months post-treatment (assessed over phone)	-5.47 change score on a scale Standard Deviation 10.29	-5.82 change score on a scale Standard Deviation 9.59	-6.56 change score on a scale Standard Deviation 9.62

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx

Population: Intent to treat

Change in non-judgment will be measured with items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. When assessed via phone, the full 6-item scale will be used while only four items are used in the EMA. Items will be averaged for a mean score from 0-4. Higher mean PCPQ scores indicate higher frequencies of using the adaptive cognitive process of non-judgment in responding to pain. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Measure	Cognitive Therapy (CT) Condition n=99 Participants Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 Participants Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.	Behavioral Activation (BA) Condition n=101 Participants Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) Change from pre- to post-treatment (assessed over phone)	0.43 change score on a scale Standard Deviation 1.14	0.45 change score on a scale Standard Deviation 1.19	0.48 change score on a scale Standard Deviation 1.20
Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) Change from pre- to 3 months post-treatment (assessed over phone)	0.39 change score on a scale Standard Deviation 1.01	0.35 change score on a scale Standard Deviation 1.34	0.57 change score on a scale Standard Deviation 1.04
Change in Non-Judgment (i.e., Cognitive Process Mechanism; Macro-level) Change from pre- to 6 months post-treatment (assessed over phone)	0.36 change score on a scale Standard Deviation 0.98	0.41 change score on a scale Standard Deviation 1.24	0.46 change score on a scale Standard Deviation 1.20

Adverse Events

Cognitive Therapy (CT) Condition

Serious events: 5 serious events

Other events: 48 other events

Deaths: 0 deaths

Mindfulness Meditation (MM) Condition

Serious events: 9 serious events

Other events: 43 other events

Deaths: 0 deaths

Behavioral Activation (BA) Condition

Serious events: 11 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cognitive Therapy (CT) Condition n=99 participants at risk Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 participants at risk Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events.	Behavioral Activation (BA) Condition n=101 participants at risk Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Infections and infestations Hospitalization for infection or illness	1.0% 1/99 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.98% 1/102 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.0% 2/101 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) New cancer diagnosis	1.0% 1/99 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Surgical and medical procedures Hospitalization for surgery or procedure	1.0% 1/99 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.0% 2/102 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.0% 2/101 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Injury, poisoning and procedural complications Victim of assault	1.0% 1/99 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Psychiatric disorders Hospitalization for mental health disorder	1.0% 1/99 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Cardiac disorders Hospitalization for cardiac event	0.00% 0/99 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.0% 2/102 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Injury, poisoning and procedural complications Hospitalization for adverse reaction to/complication during medical treatment	0.00% 0/99 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.98% 1/102 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.0% 2/101 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
General disorders Hospitalization for symptoms of unknown cause	0.00% 0/99 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.98% 1/102 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Respiratory, thoracic and mediastinal disorders Hospitalization for pulmonary event	0.00% 0/99 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.0% 2/102 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.0% 2/101 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
General disorders Hospitalization for increased pain	0.00% 0/99 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.99% 1/101 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Nervous system disorders Hospitalization for neurologic event	0.00% 0/99 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.0% 2/101 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.

Other adverse events

Measure	Cognitive Therapy (CT) Condition n=99 participants at risk Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.	Mindfulness Meditation (MM) Condition n=102 participants at risk Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events.	Behavioral Activation (BA) Condition n=101 participants at risk Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
Skin and subcutaneous tissue disorders Skin irritation from ActiGraph wear	6.1% 6/99 • Number of events 6 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	4.9% 5/102 • Number of events 5 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	5.0% 5/101 • Number of events 7 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Injury, poisoning and procedural complications Non-study related injury/accident	8.1% 8/99 • Number of events 9 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	9.8% 10/102 • Number of events 11 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	6.9% 7/101 • Number of events 7 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
General disorders Worsening chronic pain symptoms	6.1% 6/99 • Number of events 7 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	4.9% 5/102 • Number of events 5 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	7.9% 8/101 • Number of events 8 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Cardiac disorders Symptoms of cardiac disorder	1.0% 1/99 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Nervous system disorders Migraine or other neurological system symptoms	6.1% 6/99 • Number of events 6 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.9% 3/102 • Number of events 3 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	5.9% 6/101 • Number of events 9 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Surgical and medical procedures Underwent surgery or a medical procedure	8.1% 8/99 • Number of events 8 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	9.8% 10/102 • Number of events 10 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	11.9% 12/101 • Number of events 12 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
General disorders Symptoms of multiple organ systems	5.1% 5/99 • Number of events 5 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.9% 3/102 • Number of events 4 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	5.0% 5/101 • Number of events 5 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Vascular disorders Symptoms of a vascular disorder	1.0% 1/99 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.99% 1/101 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Infections and infestations New/worsening infection	5.1% 5/99 • Number of events 5 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	3.9% 4/102 • Number of events 4 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	4.0% 4/101 • Number of events 5 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Gastrointestinal disorders Symptoms of the GI region	5.1% 5/99 • Number of events 6 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.9% 3/102 • Number of events 3 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	5.0% 5/101 • Number of events 6 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Respiratory, thoracic and mediastinal disorders Respiratory symptoms/illness	7.1% 7/99 • Number of events 10 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	7.8% 8/102 • Number of events 8 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	11.9% 12/101 • Number of events 14 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) New neoplasm	2.0% 2/99 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.98% 1/102 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.99% 1/101 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Immune system disorders Experienced allergic reaction	1.0% 1/99 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Blood and lymphatic system disorders Symptoms of a blood and lymphatic system disorder	3.0% 3/99 • Number of events 3 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.99% 1/101 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Psychiatric disorders Suicidal ideation	3.0% 3/99 • Number of events 3 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Psychiatric disorders Delusional thinking	1.0% 1/99 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Psychiatric disorders Psychological stress due to completing study assessments	1.0% 1/99 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.98% 1/102 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.99% 1/101 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Injury, poisoning and procedural complications Victim of assault	1.0% 1/99 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
General disorders Undisclosed reason to ER	1.0% 1/99 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Renal and urinary disorders Symptoms of the renal/urinary system	0.00% 0/99 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.0% 2/102 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.0% 2/101 • Number of events 3 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Immune system disorders Symptoms of an immune system disorder	0.00% 0/99 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.98% 1/102 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Ear and labyrinth disorders Symptoms of an ear or labyrinth disorder	0.00% 0/99 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.98% 1/102 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/101 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Psychiatric disorders Increased depressed mood, anxiety, or PTSD	0.00% 0/99 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	3.9% 4/102 • Number of events 5 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	5.0% 5/101 • Number of events 5 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
General disorders Discomfort from wearing ActiGraph	2.0% 2/99 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.9% 3/102 • Number of events 3 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	2.0% 2/101 • Number of events 2 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
Eye disorders Symptoms of an eye disorder	0.00% 0/99 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/102 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.	0.99% 1/101 • Number of events 1 • All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months. Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.

Additional Information

Dr. Melissa Day, Co-Principal Investigator

The University of Queensland

Phone: +61 7 3365 6421

Email: m.day@uq.edu.au

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place