Trial Outcomes & Findings for Living in Full Even With Pain Study (NCT NCT03916276)

Results Overview

Respondents were asked to provide dosages and frequency of use of any opioid medications taken in the past seven days at the time of each telephone assessment. An average daily MME dose taken in the past week was computed for each assessment point, and a categorical variable was calculated to assess change throughout the trial (increase dose, decrease dose, no change).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

91 participants

Primary outcome timeframe

Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

Results posted on

2025-03-13

Participant Flow

Potential participants were identified primarily via ResearchMatch.org and via coding lists derived from medical records of UW Medicine patients. Other sources of recruitment included social media, 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.

N=288 participants were excluded before randomization with 254 not meeting inclusion criteria, 25 unable to be contacted, and 9 declining participation.

Participant milestones

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.	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.	Activation Skills (AS) 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.
Overall Study STARTED	31	29	31
Overall Study COMPLETED	28	26	29
Overall Study NOT COMPLETED	3	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Living in Full Even With Pain Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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.	Total n=91 Participants Total of all reporting groups
Age, Continuous	53.9 years STANDARD_DEVIATION 12.4 • n=5 Participants	54.4 years STANDARD_DEVIATION 11.7 • n=7 Participants	51.9 years STANDARD_DEVIATION 12.1 • n=5 Participants	53.3 years STANDARD_DEVIATION 11.6 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	24 Participants n=7 Participants	25 Participants n=5 Participants	74 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants
Race/Ethnicity, Customized White	28 participants n=5 Participants	23 participants n=7 Participants	24 participants n=5 Participants	75 participants n=4 Participants
Race/Ethnicity, Customized Black/African American	2 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	10 participants n=4 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Mixed races	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants
Race/Ethnicity, Customized Unspecified	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment United States	31 participants n=5 Participants	29 participants n=7 Participants	31 participants n=5 Participants	91 participants n=4 Participants
Baseline MME	80.7 Morphine milligram equivalent STANDARD_DEVIATION 84.7 • n=5 Participants	115.8 Morphine milligram equivalent STANDARD_DEVIATION 215.1 • n=7 Participants	75.9 Morphine milligram equivalent STANDARD_DEVIATION 79.0 • n=5 Participants	88.3 Morphine milligram equivalent STANDARD_DEVIATION 135.1 • n=4 Participants

PRIMARY outcome

Timeframe: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

Population: Intent to treat

Respondents were asked to provide dosages and frequency of use of any opioid medications taken in the past seven days at the time of each telephone assessment. An average daily MME dose taken in the past week was computed for each assessment point, and a categorical variable was calculated to assess change throughout the trial (increase dose, decrease dose, no change).

Outcome measures

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=28 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=26 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=29 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 Morphine Milligram Equivalent (MME) Average Daily Dose Increase in dose from pre- to 3 months post-treatment	5 participants	4 participants	4 participants
Change in Morphine Milligram Equivalent (MME) Average Daily Dose Decrease in dose from pre- to 6 months post-treatment	8 participants	8 participants	6 participants
Change in Morphine Milligram Equivalent (MME) Average Daily Dose No change in dose from pre- to post-treatment	11 participants	8 participants	18 participants
Change in Morphine Milligram Equivalent (MME) Average Daily Dose No change in dose from pre- to 3 months post-treatment	9 participants	11 participants	17 participants
Change in Morphine Milligram Equivalent (MME) Average Daily Dose No change in dose from pre- to 6 months post-treatment	7 participants	8 participants	14 participants
Change in Morphine Milligram Equivalent (MME) Average Daily Dose Increase in dose from pre- to post-treatment	8 participants	4 participants	5 participants
Change in Morphine Milligram Equivalent (MME) Average Daily Dose Increase in dose from pre- to 6 months post-treatment	6 participants	7 participants	5 participants
Change in Morphine Milligram Equivalent (MME) Average Daily Dose Decrease in dose from pre- to post-treatment	9 participants	14 participants	6 participants
Change in Morphine Milligram Equivalent (MME) Average Daily Dose Decrease in dose from pre- to 3 months post-treatment	12 participants	11 participants	6 participants

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 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 and converted to a total T-score with a mean of 50 and a standard deviation 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

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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) Early treatment slope	-1.61 scores on a scale Standard Deviation 4.78	-0.13 scores on a scale Standard Deviation 5.35	0.23 scores on a scale Standard Deviation 3.51
Change in Pain Interference (Micro-level) Late treatment slope	0.44 scores on a scale Standard Deviation 4.54	0.81 scores on a scale Standard Deviation 7.57	-1.38 scores on a scale Standard Deviation 3.39

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 affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed with EMA, 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

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 Affect (Micro-level) Positive Affect, early treatment	0.11 scores on a scale Standard Deviation 0.68	0.21 scores on a scale Standard Deviation 0.64	-0.01 scores on a scale Standard Deviation 0.83
Change in Affect (Micro-level) Negative Affect, early treatment	-0.15 scores on a scale Standard Deviation 0.61	0.18 scores on a scale Standard Deviation 0.89	-0.01 scores on a scale Standard Deviation 1.01
Change in Affect (Micro-level) Positive Affect, late treatment	-0.18 scores on a scale Standard Deviation 0.66	0.15 scores on a scale Standard Deviation 0.56	0.17 scores on a scale Standard Deviation 0.64
Change in Affect (Micro-level) Negative Affect, late treatment	0.02 scores on a scale Standard Deviation 0.68	0.28 scores on a scale Standard Deviation 0.66	-0.04 scores on a scale Standard Deviation 0.65

SECONDARY outcome

Timeframe: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

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 are summed and 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 physical function. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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	0.4 change score on a scale Standard Deviation 2.9	1.7 change score on a scale Standard Deviation 4.1	1.5 change score on a scale Standard Deviation 6.5
Change in Physical Function Change from pre- to 3 months post-treatment	-0.6 change score on a scale Standard Deviation 3.5	1.4 change score on a scale Standard Deviation 4.7	0.9 change score on a scale Standard Deviation 3.2
Change in Physical Function Change from pre- to 6 months post-treatment	0.3 change score on a scale Standard Deviation 4.1	3.0 change score on a scale Standard Deviation 5.2	2.3 change score on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

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. 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

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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	-3.9 change score on a scale Standard Deviation 8.6	0.3 change score on a scale Standard Deviation 8.1	0.8 change score on a scale Standard Deviation 7.8
Change in Sleep Quality Change from pre- to 3 months post-treatment	-3.4 change score on a scale Standard Deviation 6.0	-0.4 change score on a scale Standard Deviation 8.8	-0.8 change score on a scale Standard Deviation 6.8
Change in Sleep Quality Change from pre- to 6 months post-treatment	-3.3 change score on a scale Standard Deviation 6.8	-0.2 change score on a scale Standard Deviation 6.3	0.8 change score on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

Population: Intent to treat

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 and converted to a total T-score with a mean of 50 and a standard deviation 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

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 from pre- to post-treatment	-4.8 change score on a scale Standard Deviation 7.2	-6.6 change score on a scale Standard Deviation 5.4	-3.1 change score on a scale Standard Deviation 5.9
Change in Pain Interference (Macro-level) Change from pre- to 3 months post-treatment	-4.6 change score on a scale Standard Deviation 5.7	-2.9 change score on a scale Standard Deviation 5.2	-2.1 change score on a scale Standard Deviation 5.9
Change in Pain Interference (Macro-level) Change from pre- to 6 months post-treatment	-4.0 change score on a scale Standard Deviation 6.1	-3.0 change score on a scale Standard Deviation 6.2	-1.7 change score on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

Population: Intent to treat

Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed via phone, 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. When assessed with EMA, 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. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 Affect (Macro-level) Negative Affect, change from pre- to post-treatment	-2.1 change score on a scale Standard Deviation 3.8	-1.5 change score on a scale Standard Deviation 4.4	-0.6 change score on a scale Standard Deviation 2.6
Change in Affect (Macro-level) Positive Affect, change from pre- to 3 months post-treatment	-0.3 change score on a scale Standard Deviation 3.4	1.0 change score on a scale Standard Deviation 3.7	-1.2 change score on a scale Standard Deviation 3.5
Change in Affect (Macro-level) Negative Affect, change from pre- to 3 months post-treatment	-1.8 change score on a scale Standard Deviation 3.3	-1.0 change score on a scale Standard Deviation 4.2	0.5 change score on a scale Standard Deviation 3.2
Change in Affect (Macro-level) Positive Affect, change from pre- to 6 months post-treatment	0.3 change score on a scale Standard Deviation 3.4	0.7 change score on a scale Standard Deviation 3.2	-0.9 change score on a scale Standard Deviation 3.3
Change in Affect (Macro-level) Negative Affect, change from pre- to 6 months post-treatment	-1.8 change score on a scale Standard Deviation 4.2	0.3 change score on a scale Standard Deviation 3.8	0.4 change score on a scale Standard Deviation 4.6
Change in Affect (Macro-level) Positive Affect, change from pre- to post-treatment	0.6 change score on a scale Standard Deviation 3.3	1.8 change score on a scale Standard Deviation 3.0	0.4 change score on a scale Standard Deviation 2.3

OTHER_PRE_SPECIFIED outcome

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

Population: Intent to treat

Primary Mechanism Variable 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 time from the 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

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 - Mechanism) Late treatment (at 2 weeks to 4 weeks)	25400.60 activity counts Standard Deviation 416600.39	-58278.17 activity counts Standard Deviation 431604.42	93312.68 activity counts Standard Deviation 607646.06
Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism) Early treatment (at baseline to 2 weeks)	-107353.64 activity counts Standard Deviation 505760.75	-20966.51 activity counts Standard Deviation 437438.18	212816.61 activity counts Standard Deviation 644084.02

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

Primary Mechanism Variable Change in non-judgment will be measured with 4 items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. 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

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 (Cognitive Process Mechanism, Micro-level) Early treatment slope	0.1 scores on a scale Standard Deviation 0.6	0.1 scores on a scale Standard Deviation 0.8	0.05 scores on a scale Standard Deviation 0.5
Change in Non-Judgment (Cognitive Process Mechanism, Micro-level) Late treatment slope	0.00 scores on a scale Standard Deviation 0.5	0.00 scores on a scale Standard Deviation 0.7	-0.1 scores on a scale Standard Deviation 0.7

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

Primary Mechanism Variable 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

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 (Cognitive Content Mechanism, Micro-level) Early treatment slope	-2.0 scores on a scale Standard Deviation 5.5	-1.3 scores on a scale Standard Deviation 4.4	-0.8 scores on a scale Standard Deviation 4.8
Change in Pain Catastrophizing (Cognitive Content Mechanism, Micro-level) Late treatment slope	-0.5 scores on a scale Standard Deviation 6.4	-0.6 scores on a scale Standard Deviation 5.5	-1.1 scores on a scale Standard Deviation 4.1

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

Primary Mechanism Variable Change in pain intensity of chronic pain 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

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 (Mechanism, Micro-level) Late treatment slope	0.2 scores on a scale Standard Deviation 1.1	0.2 scores on a scale Standard Deviation 1.5	-0.4 scores on a scale Standard Deviation 1.1
Change in Pain Intensity (Mechanism, Micro-level) Early treatment slope	-0.1 scores on a scale Standard Deviation 1.03	0.3 scores on a scale Standard Deviation 0.8	0.2 scores on a scale Standard Deviation 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

Population: Intent to treat

Change in depression and anxiety will be measured with the respective Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms. Responses were summed for a total raw score for depression and anxiety. 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 depression and anxiety. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 and Anxiety Severity (Mechanism, Macro-level) Pre- to post-treatment change in Depression	-3.25 change score on a scale Standard Deviation 7.00	-2.61 change score on a scale Standard Deviation 7.83	-2.55 change score on a scale Standard Deviation 6.65
Change in Depression and Anxiety Severity (Mechanism, Macro-level) Pre- to post-treatment change in Anxiety	-2.23 change score on a scale Standard Deviation 7.11	-2.14 change score on a scale Standard Deviation 7.94	-1.49 change score on a scale Standard Deviation 7.21
Change in Depression and Anxiety Severity (Mechanism, Macro-level) Pre- to 3 months post-treatment change in Depression	-2.41 change score on a scale Standard Deviation 6.92	-2.26 change score on a scale Standard Deviation 8.22	-1.99 change score on a scale Standard Deviation 6.45
Change in Depression and Anxiety Severity (Mechanism, Macro-level) Pre- to 3 months post-treatment change in Anxiety	-1.38 change score on a scale Standard Deviation 8.56	-2.20 change score on a scale Standard Deviation 8.97	-0.45 change score on a scale Standard Deviation 8.34
Change in Depression and Anxiety Severity (Mechanism, Macro-level) Pre- to 6 months post-treatment change in Depression	-2.34 change score on a scale Standard Deviation 7.70	-2.19 change score on a scale Standard Deviation 9.38	-1.87 change score on a scale Standard Deviation 7.44
Change in Depression and Anxiety Severity (Mechanism, Macro-level) Pre- to 6 months post-treatment change in Anxiety	-1.85 change score on a scale Standard Deviation 8.42	-1.41 change score on a scale Standard Deviation 9.40	0.06 change score on a scale Standard Deviation 8.92

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

Secondary Mechanism Variable Self-reported change in activity level will be measured via the Godin Leisure-Time Exercise Questionnaire (GLTEQ). The daily EMA items asked how many times that day did the participant engage in \>15mins of strenuous exercise, \>15mins of moderate exercise and \>15mins of mild exercise. The total frequencies for each category for a week were summed, and this scoring formula was applied to calculate overall units of activity: Activity Score = (9 x Freq. of Strenuous)+(5 x Freq. of Moderate)+(3 x Freq. of Mild). The lowest possible score is zero, while no theoretical maximum score exists. Higher scores indicate higher levels of activity. 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

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 (Self-report Mechanism, EMA) Early treatment slope	3.3 scores on a scale Standard Deviation 25.4	-1.0 scores on a scale Standard Deviation 23.2	-0.3 scores on a scale Standard Deviation 20.5
Change in Activity Level (Self-report Mechanism, EMA) Late treatment slope	-2.1 scores on a scale Standard Deviation 16.5	6.6 scores on a scale Standard Deviation 19.8	8.0 scores on a scale Standard Deviation 21.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

Population: Intent to treat

Secondary Mechanism Variable Self-reported change in activity level will be measured via the Godin Leisure-Time Exercise Questionnaire (GLTEQ). Participants were asked how many times in the past 7-days did they engage in \>15mins of strenuous exercise, \>15mins of moderate exercise and \>15mins of mild exercise. This scoring formula was applied to calculate overall units of activity: Activity Score = (9 x Freq. of Strenuous)+(5 x Freq. of Moderate)+(3 x Freq. of Mild). The lowest possible score is zero, while no theoretical maximum score exists. Higher scores indicate higher levels of activity. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Outcome measures

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 (Self-report Mechanism, Telephone Assessed) Change from pre- to 6 months post-treatment	0.89 change score on a scale Standard Deviation 114.42	0.59 change score on a scale Standard Deviation 34.73	0.05 change score on a scale Standard Deviation 33.12
Change in Activity Level (Self-report Mechanism, Telephone Assessed) Change from pre- to post-treatment	13.31 change score on a scale Standard Deviation 41.67	11.63 change score on a scale Standard Deviation 45.34	20.65 change score on a scale Standard Deviation 51.77
Change in Activity Level (Self-report Mechanism, Telephone Assessed) Change from pre- to 3 months post-treatment	16.40 change score on a scale Standard Deviation 151.63	1.83 change score on a scale Standard Deviation 53.54	45.75 change score on a scale Standard Deviation 193.01

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

Population: Intent to treat

Primary Mechanism Variable Change in non-judgment will be measured with items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. The full 6-item scale will be used. 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

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 (Cognitive Process Mechanism, Macro-level) Change from pre- to post-treatment	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 1.18
Change in Non-Judgment (Cognitive Process Mechanism, Macro-level) Change from pre- to 3 months post-treatment	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 (Cognitive Process Mechanism, Macro-level) Change from pre- to 6 months post-treatment	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

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

Population: Intent to treat

Primary Mechanism Variable 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

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 (Cognitive Content Mechanism, Macro-level) Change from pre- to post-treatment	-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 (Cognitive Content Mechanism, Macro-level) Change from pre- to 3 months post-treatment	-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 9.49
Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level) Change from pre- to 6 months post-treatment	-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 (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

Population: Intent to treat

Primary Mechanism Variable Change in pain intensity of chronic pain 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

Outcome measures
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 (Mechanism, Macro-level) Pre- to 6 months post-treatment change	-0.96 change score on a scale Standard Deviation 1.87	-1.03 change score on a scale Standard Deviation 1.99	-1.09 change score on a scale Standard Deviation 2.03
Change in Pain Intensity (Mechanism, Macro-level) Pre- to post-treatment change	-0.99 change score on a scale Standard Deviation 1.80	-1.18 change score on a scale Standard Deviation 2.13	-1.29 change score on a scale Standard Deviation 1.90
Change in Pain Intensity (Mechanism, Macro-level) Pre- to 3 months post-treatment change	-0.90 change score on a scale Standard Deviation 1.70	-0.82 change score on a scale Standard Deviation 1.89	-1.40 change score on a scale Standard Deviation 2.23

Adverse Events

Cognitive Therapy (CT) Condition

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Mindfulness Meditation (MM) Condition

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Behavioral Activation (BA) Condition

Serious events: 4 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cognitive Therapy (CT) Condition n=31 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=29 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=31 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 related to new infection/illness	3.2% 1/31 • 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% 0/29 • 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.	3.2% 1/31 • 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.
Respiratory, thoracic and mediastinal disorders Hospitalization due to new/existing respiratory illness	3.2% 1/31 • 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% 0/29 • 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.	3.2% 1/31 • 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 Hospitalization due to new/existing immune system illness	3.2% 1/31 • 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% 0/29 • 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% 0/31 • 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 related to a surgery/procedure	0.00% 0/31 • 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% 0/29 • 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.	3.2% 1/31 • 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 Hospitalization related to suicidal ideation	0.00% 0/31 • 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% 0/29 • 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.	3.2% 1/31 • 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.
General disorders Hospitalization due to illness of multiple organ systems	0.00% 0/31 • 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% 0/29 • 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.	3.2% 1/31 • 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.

Other adverse events

Additional Information

Dr. Melissa Day, Co-Principal Investigator

The University of Queensland

Phone: +61 7 3365 6421

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place