Trial Outcomes & Findings for Chronic Pain Skills Study (NCT NCT02653664)

Last Updated: 2021-10-29

Results Overview

An average of all of the 24-hour ratings (range=1-4 ratings) of average pain intensity was obtained over a period of one week during each assessment period, pre-treatment and post-treatment. Range: 0-10, 0='no pain' and 10 ='pain as bad as you can imagine' The difference between the two average scores from the different assessment periods (pre-treatment and post-treatment) was computed by subtracting the pre-treatment score from the post-treatment score, resulting in a change score. A negative value denotes a decrease in pain intensity between the two assessment periods, whereas a positive value denotes an increase.

Recruitment status

COMPLETED

Study phase

Target enrollment

343 participants

Primary outcome timeframe

Change in Average Pain Intensity from Pre-Treatment to Immediately Following End of Approximately Eight Weeks of Treatment (Post-Treatment)

Results posted on

2021-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Condition #1: PsychoEducation (ED) Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to. PsychoEducation: Condition #1	Condition #2:Self-Hypnosis Training (HYP) In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality). Self-Hypnosis Training: Condition #2	Condition #3: Mindfulness Meditation (MM) In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice. Mindfulness Meditation: Condition #3
Post-Treatment STARTED	110	110	108
Post-Treatment Primary and Secondary Data	93	104	91
Post-Treatment Primary Outcome Data Only	3	0	3
Post-Treatment COMPLETED	96	104	94
Post-Treatment NOT COMPLETED	14	6	14
3 Month Follow-Up STARTED	110	110	108
3 Month Follow-Up Primary and Secondary Data	83	95	82
3 Month Follow-Up Primary Outcome Data Only	6	0	1
3 Month Follow-Up COMPLETED	89	95	83
3 Month Follow-Up NOT COMPLETED	21	15	25
6 Month Follow-Up STARTED	110	110	108
6 Month Follow-Up Primary and Secondary Outcome Data	85	87	83
6 Month Follow-Up Primary Outcome Data Only	2	2	2
6 Month Follow-Up COMPLETED	87	89	85
6 Month Follow-Up NOT COMPLETED	23	21	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Condition #1: PsychoEducation (ED) Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to. PsychoEducation: Condition #1	Condition #2:Self-Hypnosis Training (HYP) In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality). Self-Hypnosis Training: Condition #2	Condition #3: Mindfulness Meditation (MM) In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice. Mindfulness Meditation: Condition #3
Post-Treatment Withdrawal by Subject	6	5	7
Post-Treatment Lost to Follow-up	8	1	7
3 Month Follow-Up Withdrawal by Subject	9	5	9
3 Month Follow-Up Lost to Follow-up	9	8	16
3 Month Follow-Up Investigator Withdrawn, Behavioral Issues	0	2	0
3 Month Follow-Up Subject Declined Assessment Period, Remained Enrolled in Trial	3	0	0
6 Month Follow-Up Withdrawal by Subject	13	7	14
6 Month Follow-Up Lost to Follow-up	10	11	9
6 Month Follow-Up Investigator Withdrawn, Behavioral Issues	0	2	0
6 Month Follow-Up Subject Declined Assessment Period	0	1	0

Baseline Characteristics

Chronic Pain Skills Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Condition #1: PsychoEducation n=110 Participants Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to. PsychoEducation: Condition #1	Condition #2:Self-Hypnosis Training n=110 Participants In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality). Self-Hypnosis Training: Condition #2	Condition #3: Mindfulness Meditation n=108 Participants In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice. Mindfulness Meditation: Condition #3	Total n=328 Participants Total of all reporting groups
Age, Continuous	53.5 years STANDARD_DEVIATION 13.5 • n=5 Participants	51.0 years STANDARD_DEVIATION 12.6 • n=7 Participants	55.0 years STANDARD_DEVIATION 13.0 • n=5 Participants	53.2 years STANDARD_DEVIATION 13.1 • n=4 Participants
Sex/Gender, Customized Gender, n · Men	80 Participants n=5 Participants	81 Participants n=7 Participants	80 Participants n=5 Participants	241 Participants n=4 Participants
Sex/Gender, Customized Gender, n · Women	27 Participants n=5 Participants	29 Participants n=7 Participants	28 Participants n=5 Participants	84 Participants n=4 Participants
Sex/Gender, Customized Gender, n · Transgender	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants	30 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	101 Participants n=5 Participants	97 Participants n=7 Participants	91 Participants n=5 Participants	289 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	23 Participants n=7 Participants	16 Participants n=5 Participants	58 Participants n=4 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants	71 Participants n=7 Participants	68 Participants n=5 Participants	207 Participants n=4 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Education Level High School or Less	11 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	26 Participants n=4 Participants
Education Level Some College/Technical	48 Participants n=5 Participants	54 Participants n=7 Participants	52 Participants n=5 Participants	154 Participants n=4 Participants
Education Level College Degree or Higher	51 Participants n=5 Participants	47 Participants n=7 Participants	50 Participants n=5 Participants	148 Participants n=4 Participants
Employment Status Unemployed	54 Participants n=5 Participants	48 Participants n=7 Participants	36 Participants n=5 Participants	138 Participants n=4 Participants
Employment Status Retired	45 Participants n=5 Participants	42 Participants n=7 Participants	47 Participants n=5 Participants	134 Participants n=4 Participants
Employment Status Employed Full/Part Time	26 Participants n=5 Participants	32 Participants n=7 Participants	30 Participants n=5 Participants	88 Participants n=4 Participants
Employment Status Student Full/Part Time	4 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	17 Participants n=4 Participants
Employment Status Home Maker	6 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Married, Living with Partner	67 Participants n=5 Participants	60 Participants n=7 Participants	55 Participants n=5 Participants	182 Participants n=4 Participants
Homeless in Past Six Months	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Type of Pain Probable Neuropathic	58 Participants n=5 Participants	53 Participants n=7 Participants	49 Participants n=5 Participants	160 Participants n=4 Participants
Type of Pain Probable Non-Neuropathic	27 Participants n=5 Participants	26 Participants n=7 Participants	27 Participants n=5 Participants	80 Participants n=4 Participants
Type of Pain Uncertain	25 Participants n=5 Participants	31 Participants n=7 Participants	32 Participants n=5 Participants	88 Participants n=4 Participants
Very Good/ Excellent Health	12 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	32 Participants n=4 Participants
Prior Pain Education	50 Participants n=5 Participants	42 Participants n=7 Participants	36 Participants n=5 Participants	128 Participants n=4 Participants
Prior Experience in Hypnosis	17 Participants n=5 Participants	24 Participants n=7 Participants	27 Participants n=5 Participants	68 Participants n=4 Participants
Prior Experience in Meditation	64 Participants n=5 Participants	63 Participants n=7 Participants	62 Participants n=5 Participants	189 Participants n=4 Participants
Average Pain Intensity	5.8 scores on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	5.7 scores on a scale STANDARD_DEVIATION 1.8 • n=7 Participants	5.9 scores on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	5.8 scores on a scale STANDARD_DEVIATION 1.7 • n=4 Participants
Worst Pain Intensity	7.3 scores on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	7.0 scores on a scale STANDARD_DEVIATION 1.8 • n=7 Participants	7.2 scores on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	7.2 scores on a scale STANDARD_DEVIATION 1.7 • n=4 Participants
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Instrument	64.6 T-score STANDARD_DEVIATION 5.0 • n=5 Participants	63.4 T-score STANDARD_DEVIATION 5.0 • n=7 Participants	64.0 T-score STANDARD_DEVIATION 5.8 • n=5 Participants	64.0 T-score STANDARD_DEVIATION 5.3 • n=4 Participants
PROMIS Sleep Disturbance Instrument	59.2 T-score STANDARD_DEVIATION 8.5 • n=5 Participants	59.0 T-score STANDARD_DEVIATION 8.5 • n=7 Participants	57.9 T-score STANDARD_DEVIATION 9 • n=5 Participants	58.7 T-score STANDARD_DEVIATION 8.7 • n=4 Participants
PROMIS Anxiety Instrument	58.4 T-score STANDARD_DEVIATION 8.9 • n=5 Participants	57.0 T-score STANDARD_DEVIATION 9.5 • n=7 Participants	57.2 T-score STANDARD_DEVIATION 9.3 • n=5 Participants	57.5 T-score STANDARD_DEVIATION 9.2 • n=4 Participants
PROMIS Depression Instrument	55.6 T-score STANDARD_DEVIATION 8.8 • n=5 Participants	54.1 T-score STANDARD_DEVIATION 9.3 • n=7 Participants	53.4 T-score STANDARD_DEVIATION 8.9 • n=5 Participants	54.4 T-score STANDARD_DEVIATION 9.0 • n=4 Participants
Posttraumatic Stress Disorder Checklist (PCL-5) Score	34.3 scores on a scale STANDARD_DEVIATION 17.4 • n=5 Participants	32.6 scores on a scale STANDARD_DEVIATION 18.6 • n=7 Participants	31.4 scores on a scale STANDARD_DEVIATION 17.3 • n=5 Participants	32.8 scores on a scale STANDARD_DEVIATION 17.8 • n=4 Participants
Classified As Having PTSD	63 Participants n=5 Participants	53 Participants n=7 Participants	49 Participants n=5 Participants	165 Participants n=4 Participants
Any Opioid Analgesic Use, Baseline	35 Participants n=5 Participants	19 Participants n=7 Participants	30 Participants n=5 Participants	84 Participants n=4 Participants
Morphine Equivalent Dose	6.0 milligrams, morphine equivalent STANDARD_DEVIATION 15.3 • n=5 Participants	5.9 milligrams, morphine equivalent STANDARD_DEVIATION 20.6 • n=7 Participants	6.3 milligrams, morphine equivalent STANDARD_DEVIATION 16.1 • n=5 Participants	6.2 milligrams, morphine equivalent STANDARD_DEVIATION 17.5 • n=4 Participants

PRIMARY outcome

Timeframe: Change in Average Pain Intensity from Pre-Treatment to Immediately Following End of Approximately Eight Weeks of Treatment (Post-Treatment)

Population: Intent to treat population (all participants assigned to one of the three interventions). Multiple imputation was performed for missing values of change in score at each follow-up time prior to final data analysis. Twenty sets of imputed data for the changes outcome at each time were modeled using pre-treatment values of the outcome, age, gender, employment (yes/no), and treatment group as explanatory variables, using a chained equations approach.

Outcome measures

Outcome measures
Measure	Condition #1: PsychoEducation (ED) n=110 Participants Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to. PsychoEducation: Condition #1	Condition #2:Self-Hypnosis Training (HYP) n=110 Participants In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality). Self-Hypnosis Training: Condition #2	Condition #3: Mindfulness Meditation (MM) n=108 Participants In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice. Mindfulness Meditation: Condition #3
Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale Immediately Following End of Treatment (Post-Treatment)	-.57 score on a scale Interval -0.63 to -0.52	-.61 score on a scale Interval -0.67 to -0.56	-.85 score on a scale Interval -90.0 to -0.79

OTHER_PRE_SPECIFIED outcome

Timeframe: Change in Average Pain Intensity from Pre-Treatment to 3 Months Following End of Treatment

An average of all of the 24-hour ratings (range=1-4 ratings) of average pain intensity was obtained over a period of one week during each assessment period, pre-treatment and 3 months following the end of treatment. Range: 0-10, 0='no pain' and 10 ='pain as bad as you can imagine' The difference between the two average scores from the different assessment periods (pre-treatment and 3 months following end of treatment) was computed by subtracting the pre-treatment score from the 3 months following end of treatment score, resulting in a change score. A negative value denotes a decrease in pain intensity between the two assessment periods, whereas a positive value denotes an increase.

Outcome measures

Outcome measures
Measure	Condition #1: PsychoEducation (ED) n=110 Participants Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to. PsychoEducation: Condition #1	Condition #2:Self-Hypnosis Training (HYP) n=110 Participants In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality). Self-Hypnosis Training: Condition #2	Condition #3: Mindfulness Meditation (MM) n=108 Participants In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice. Mindfulness Meditation: Condition #3
Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale 3 Months Following End of Treatment	-.48 score on a scale Interval -0.55 to -0.42	-.95 score on a scale Interval -1.02 to -0.88	-.67 score on a scale Interval -0.74 to -0.61

OTHER_PRE_SPECIFIED outcome

Timeframe: Change in Average Pain Intensity from Pre-Treatment to 6 Months Following End of Treatment

An average of all of the 24-hour ratings (range=1-4 ratings) of average pain intensity was obtained over a period of one week during each assessment period, pre-treatment and 6 months following the end of treatment. Range: 0-10, 0='no pain' and 10 ='pain as bad as you can imagine' The difference between the two average scores from the different assessment periods (pre-treatment and 6 months following end of treatment) was computed by subtracting the pre-treatment score from the 6 months following end of treatment score, resulting in a change score. A negative value denotes a decrease in pain intensity between the two assessment periods, whereas a positive value denotes an increase.

Outcome measures

Outcome measures
Measure	Condition #1: PsychoEducation (ED) n=110 Participants Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to. PsychoEducation: Condition #1	Condition #2:Self-Hypnosis Training (HYP) n=110 Participants In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality). Self-Hypnosis Training: Condition #2	Condition #3: Mindfulness Meditation (MM) n=108 Participants In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice. Mindfulness Meditation: Condition #3
Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale 6 Months Following End of Treatment	-.28 score on a scale Interval -0.34 to -0.22	-1.04 score on a scale Interval -1.11 to -0.98	-.86 score on a scale Interval -0.92 to -0.8

Adverse Events

Condition #1: PsychoEducation

Serious events: 22 serious events

Other events: 73 other events

Deaths: 0 deaths

Condition #2:Self-Hypnosis Training

Serious events: 12 serious events

Other events: 63 other events

Deaths: 0 deaths

Condition #3: Mindfulness Meditation

Serious events: 18 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Mark Jensen

University of Washington

Phone: 206-543-3185

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Condition #1: PsychoEducation n=110 participants at risk Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to. PsychoEducation: Condition #1	Condition #2:Self-Hypnosis Training n=110 participants at risk In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality). Self-Hypnosis Training: Condition #2	Condition #3: Mindfulness Meditation n=108 participants at risk In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice. Mindfulness Meditation: Condition #3
General disorders New/Unusual/ Worsening Pain or Physical Discomfort At Least Possibly Related to Study Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders Medically Important Surgery or Medical Procedure, Unrelated to Study Procedures	11.8% 13/110 • Number of events 15 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	4.5% 5/110 • Number of events 5 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	5.6% 6/108 • Number of events 8 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New Cancer Diagnosis, Unrelated to Study Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
Nervous system disorders Seizures, Unrelated to Study Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
Injury, poisoning and procedural complications New Physical Injury, Unrelated to Study Procedures	1.8% 2/110 • Number of events 3 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	1.8% 2/110 • Number of events 2 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	2.8% 3/108 • Number of events 3 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
Psychiatric disorders Life Threatening Suicidal Ideation/Attempt, Unrelated to Study Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	1.9% 2/108 • Number of events 3 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
Psychiatric disorders Homicidal Ideation, Unrelated to Study Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders Inpatient Hospitalization, Unrelated to Study Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	2.7% 3/110 • Number of events 3 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	2.8% 3/108 • Number of events 3 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
Blood and lymphatic system disorders Inpatient Hospitalization, Unrelated to Study Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
Cardiac disorders Inpatient Hospitalization, Unrelated to Study Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.91% 1/110 • Number of events 2 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
Gastrointestinal disorders Inpatient Hospitalization, Unrelated to Study Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
Injury, poisoning and procedural complications Inpatient Hospitalization, Unrelated to Study Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
Psychiatric disorders Inpatient Hospitalization, Unrelated to Study Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
Renal and urinary disorders Inpatient Hospitalization, Unrelated to Study Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
Respiratory, thoracic and mediastinal disorders Inpatient Hospitalization, Unrelated to Study Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Pain or Physical Discomfort Unrelated to Study Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.

Measure	Condition #1: PsychoEducation n=110 participants at risk Condition #1 will include 8 90-minute group sessions that will educate the subject about chronic pain, discuss the impact of pain, and inform the subject of different ways to manage it in hopes of decreasing pain and its impact on the subject's life. Participants in this condition will be given pre-recorded audio recordings of the content of the sessions to listen to. PsychoEducation: Condition #1	Condition #2:Self-Hypnosis Training n=110 participants at risk In condition #2, the facilitator will perform a standard hypnotic short induction followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the clinician read a standardized hypnotic script that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality). Self-Hypnosis Training: Condition #2	Condition #3: Mindfulness Meditation n=108 participants at risk In condition #3, the facilitator will teach participants Vipassana meditation, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Time will also be devoted to problem solving around any difficulties with MM practice. Mindfulness Meditation: Condition #3
General disorders New Physical Injury, Unrelated to Study Procedures	8.2% 9/110 • Number of events 10 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	11.8% 13/110 • Number of events 15 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	13.9% 15/108 • Number of events 20 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Nausea, At Least Possibly Related to EEG Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Nausea, At Least Possibly Related to Treatment Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Nausea, Unrelated to Study Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders Adverse Medication Reaction, Unrelated to Study Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	1.8% 2/110 • Number of events 2 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	3.7% 4/108 • Number of events 4 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New Diagnosis, Not Life Threatening, Unrelated to Study Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New Illness/Infection/Untoward Medical Occurrence Unrelated to Study Procedures	31.8% 35/110 • Number of events 60 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	28.2% 31/110 • Number of events 60 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	25.9% 28/108 • Number of events 41 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New Illness/Infection/Untoward Medical Occurrence, At Least Possibly Related to Treatment Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	1.8% 2/110 • Number of events 2 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Cognitive Difficulties, Unrelated to Study Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 2 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Fatigue, Unrelated to Study Procedures	2.7% 3/110 • Number of events 3 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	3.6% 4/110 • Number of events 5 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	3.7% 4/108 • Number of events 4 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Headache/Migraine, At Least Possibly Related to Study Self-Report Measures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Headache/Migraine, At Least Possibly Related to EEG Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/ Worsening Headache/Migraine, At Least Possibly Related to Baseline Hypnotizability Assessment	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Headache/Migraine, Unrelated to Study Procedures	9.1% 10/110 • Number of events 11 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	9.1% 10/110 • Number of events 16 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	4.6% 5/108 • Number of events 7 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Pain or Physical Discomfort Unrelated to Study Procedures	20.9% 23/110 • Number of events 36 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	19.1% 21/110 • Number of events 34 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	21.3% 23/108 • Number of events 42 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Worsening Psych. Discomfort At Least Possibly Related to Baseline Hypnotizability Assessment	1.8% 2/110 • Number of events 2 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	3.6% 4/110 • Number of events 4 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	5.6% 6/108 • Number of events 6 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Worsening Psychological Discomfort At Least Possibly Related to Study Procedures, General	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to EEG Procedures	1.8% 2/110 • Number of events 2 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	5.5% 6/110 • Number of events 6 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	2.8% 3/108 • Number of events 3 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to Self-Report Measures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	2.7% 3/110 • Number of events 3 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	3.7% 4/108 • Number of events 5 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to Treatment Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	6.4% 7/110 • Number of events 8 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	2.8% 3/108 • Number of events 3 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Psychological Discomfort, Unrelated to Study Procedures	6.4% 7/110 • Number of events 8 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	10.9% 12/110 • Number of events 16 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	10.2% 11/108 • Number of events 11 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Worsening Skin Irritation, At Least Possibly Related to Wearing Sleep Sub-Study Actigraph Device	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	4.5% 5/110 • Number of events 6 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Sleep Problems, At Least Possibly Related to Sleep Sub-Study Procedures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Sleep Problems, At Least Possibly Related to Treatment Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/ Worsening Sleep Problems Unrelated to Study Procedures	1.8% 2/110 • Number of events 2 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	4.5% 5/110 • Number of events 5 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	2.8% 3/108 • Number of events 3 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Worsening Pain, Phys. Discomfort at Least Possibly Related to Baseline Hypno. Assessment	6.4% 7/110 • Number of events 7 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	2.7% 3/110 • Number of events 3 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	1.9% 2/108 • Number of events 2 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to Consent Session	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	1.8% 2/110 • Number of events 2 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/108 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to EEG Procedures	7.3% 8/110 • Number of events 8 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	2.7% 3/110 • Number of events 3 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	3.7% 4/108 • Number of events 5 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to Self-Report Measures	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to Treatment Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	6.4% 7/110 • Number of events 7 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	7.4% 8/108 • Number of events 8 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders Non-Life Threatening Suicidal Ideation, Unrelated to Study Procedures	0.91% 1/110 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.00% 0/110 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	0.93% 1/108 • Number of events 1 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
General disorders Non-Life Threatening/ Outpatient Surgery or Medical Procedure, Unrelated to Study Procedures	20.0% 22/110 • Number of events 24 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	12.7% 14/110 • Number of events 20 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.	16.7% 18/108 • Number of events 25 • Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.