CPSS: Chronic Pain Skills Study

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT02653664
• Collaborator: VA Puget Sound Health Care System (U.S. Fed), Washington State University (Other)
• Enrollment: 343
• Locations: 5
• Arms: 3
• Actual Duration (Months): 53.7
• Patients Per Site: 68.6
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

Chronic pain is a significant problem for many Veterans, including new Veterans returning from Iraq and Afghanistan. It is also associated with a number of other significant problems, such as post-traumatic stress disorder and sleep problems. All of these can have significant negative effects of the quality of life of Veterans

Three different types of treatment that have been used to treat chronic pain in the general population include self-hypnosis, education about chronic pain, and teaching individuals how to be more mindful. The purpose of this study is to see if these three treatments can help decrease pain in Veterans. Additionally, the researchers want to determine if each of these treatments can help reduce the negative consequences associated with pain, such as changes in mood, sleep, and enjoyment of life.

Different types of treatment that include self-hypnosis, education about chronic pain, and learning skills on how to change how a person perceives his/her pain have been used to treat chronic pain the general population.

The purpose of this study of this study is to see if these different treatments can help decrease pain and improve quality of life in Veterans with chronic pain, and determine how and why these treatments are effective. A subject must have a Veteran status, have chronic pain, speak English and be at least 18 years old to participate.

Sleep Sub-Study

Chronic pain and sleep problems are common among Veterans. Study researchers believe the treatment interventions provided as part of the main study will help improve pain and sleep. However, the main study does not include a "real time" measurement of sleep nor does it include any specific strategies for examining the relationship between sleep and pain.

Previous research has shown that adequate sleep has been linked to improvements in pain reports. Adversely, sleep deprivation has been found to increase pain perception since it decreases a person's ability to disengage from pain. Therefore, the purpose of this sub-study is to measure sleep in order to learn more about how it interacts with chronic pain.

All of the subjects in this sub-study will be Veterans recruited from VA Puget Sound who experience moderate-to-severe chronic pain on a regular basis and who have enrolled in the main study. Study investigators will enroll up to 135 subjects into the sub-study.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: PsychoEducation; Behavioral: Self-Hypnosis Training; Behavioral: Mindfulness Meditation	N/A

Detailed Description

Cognitive Assessment

Following enrollment, research staff will administer a battery of five neuropsychological measures assessing memory, information processing, and executive functioning. These measures take approximately 20-30 minutes to complete.

Hypnotic and Relaxation Exercise

A research staff member will administer in person the Modified Stanford Hypnotic Clinical Scale (SHCS) to assess hypnotizability for all participants following enrollment but prior to randomization. This measure takes approximately 15-20 minutes to complete.

Baseline Data and Demographic Form

A research staff member will then ask the participant to provide demographic data (age, sex, marital status, income, education level, employment status) and deployment history (number and month of deployments, whether deployment involved hostile duty) for descriptive purposes. Study investigators will also ask participants their history of receiving the study treatments, and the presence of history of military sexual trauma.

The baseline data and demographic form will take approximately 20-30 minutes to complete, and may be completed following enrollment either in person or over the telephone at a later time if more convenient for the participant.

Brain Wave Activity (or EEG) Assessment

Brain wave activity will be assessed following enrollment by conducting a brain wave activity or EEG assessment. The brain wave activity assessment will take place at the Integrated Brain Imaging Center (IBIC) at the University of Washington main campus. The IBIC is a research-dedicated technology center organized under the department of Radiology.

EEG will be sampled with an electrode array using an electrode net dipped in a saline solution. The research staff member, an IBIC employee with a Without Compensation (WOC) appointment at the VA Puget Sound Health Care System (VAPSHCS), will collect the EEG activity data, and ask the participant to remain as still as possible during portions of the assessment.

The EEG technician will collect from the participant data regarding medication used within 24 hours of assessment. He/she will also ask the participant to rate the intensity of his or her pain just before the assessment (current pain), after a few minutes of the assessment (current pain and worst, least, and average pain over the past few minutes), and at the end of the EEG session (current pain, and worst, least, and average pain over the past few minutes), using 0-10 Numerical Rating Scales.

The entire brain wave activity assessment will take approximately 45-60 minutes to complete. Subjects will be asked to complete the same brain activity assessment following completion of treatment following the same procedures above. Participants may still participate in the study if they decline to participate in the EEG assessments.

Assessment: Pre-Treatment and General Overview

Subjective reports of pain intensity vary over time, and to most accurately measure pain intensity (our primary outcome), it is most valid to assess multiple times and take an average. Hence, study investigators have developed a method of assessment that will seek to obtain up to four telephone assessments over a period of one week or 7 days with a minimum of 24 hours between each assessment. During each telephone contact, research staff will ask participants, at minimum, to rate their current, average, worst and least pain intensity over the past 24 hours, as well as their average pain intensity over the past 7 days. In addition, if possible, research staff will ask the participant to rate their current, average, worst and least pain intensity over the past week during the final telephone contact. These assessments will be referred to as "short assessments." The primary outcome will be an average of all of the 24-hour ratings (range=1-4 ratings) of average pain intensity obtained over a period of one week during each assessment period.

In addition, sometime during this assessment period researchers will ask questions regarding pain interference, depression, anxiety, sleep disturbance, post-traumatic stress disorder (PTSD) symptoms, medication use, medical services utilization, thoughts about pain and treatment motivation. This latter set of questions will only be asked once during the assessment period, and will be referred to as "the long assessment." Research staff will give participants the option to: 1) complete the long assessment during one of the four short telephone assessments described above; or 2) spread the long assessment across several days during the assessment period. The entire long assessment or portions thereof may fall up to two days outside the 7-day period for the four short assessments.

The entire time required to answer questions during the assessment period is 45-60 minutes.

The assessment period described above will be completed prior to initiating treatment, and then after completion of treatment sessions #2, 4 and 6 and 8 (i.e. post-treatment), and 3 and 6 months following the end of treatment for a total of seven times. These assessment periods that occur following the start of treatment will also include questions about group climate, therapeutic alliance with the group clinician, treatment satisfaction, and overall improvement since the participant began the pain program.

Randomization

Enrolled participants who complete the required baseline components (cognitive assessment, hypnotic and relaxation exercise, baseline data form, and pre-treatment assessment period) will be randomized in stratified blocks to ensure that participants with each sex and pain type (neuropathic, non-neuropathic, mixed or undetermined) have an equal chance of being randomized to one of the 3 conditions.

Treatment Scheduling

Cohorts of study intervention groups will be offered beginning every four months. In each 4-month period, there will be two class options for each condition, one based in Seattle and one at American Lake. Thus, there will be six classes offered per four month period, or a total of 18 classes per year.

Up to 15 participants can be enrolled in each intervention class; 10 spots will be protected for research participants, and the remaining 5 for Veterans who have completed the study and wish to try another type of intervention, or who are non-research participants. If any protected research spots are not filled at the start of a cohort, non-research participants will be offered those spots and vice versa.

Treatment

In all three treatment conditions, intervention appointments will be scheduled in regular group clinics at the VA facility (American Lake or Seattle). This means that treatment sessions will appear on the Veterans' lists of regular clinical appointments. Although the appointments are scheduled for 90 minutes, in practice they will last 60-80 minutes, with a 10 minute time cushion built in to allow for participants who may have mobility limitations to arrive, settle, and then vacate the group rooms without hurrying.

The group sessions will be conducted by VAPSHCS providers who have undergone a formal two-day training process that prepares clinicians to conduct each of the three treatment interventions in a group setting.

In all conditions, home practice activities will be assigned to increase engagement in the treatment. Participants will be asked to record the extent of engagement in these activities using a form provided to them by the clinician. Study investigators realize that adherence to interventions assigned outside of treatment sessions may influence study outcomes so will utilize data collected by the clinicians about homework compliance. In addition, all participants in all interventions will be given a treatment workbook with materials to refer to and discuss during the group sessions as well as additional materials to read between sessions.

Please see below for description of study treatment interventions.

Data Collected during Treatment Sessions

Participants will complete and hand in a form regarding their completion of tasks or "homework" assigned by the clinician from the previous session.

In addition, participants will complete and hand in forms before and after each session that include questions regarding pain intensity and comfort level, as well as questions about what the participants have found helpful or non-helpful about the treatment. Finally, study clinicians will complete a form each session that captures information regarding the perceived engagement of each participant in that particular session. All of these forms will be labeled with a subject's name.

Audio Recordings

The group treatment sessions will be audio recorded to make sure the study clinician is following study procedures.

Optional Assessments

For the pre-treatment and post-treatment telephone assessment periods, research staff will use a script to invite participants upon completing the assessment period to participate in an optional assessment consisting of two measures developed by study researchers. The optional assessment should take approximately 10-15 minutes to complete, and consists of questions about how participants feel when they feel pain or think about their pain problem, and how participants respond to their pain.

Open Label Phase

Following the completion of the 6-month telephone assessment period research staff will invite participants to complete in one or both of the treatment groups they did not attend during participation in the main phase. Participants would only participate in one treatment group at a time. The open label phase does not include any screening procedures; all research participants are welcome to participate. Research staff will schedule a consent session if the participant is interested in participating in the 'open label phase' of the study.

Sleep Sub-Study

Subjects enrolled in the main study will be offered the opportunity to participate concurrently in the sleep sub-study. All subjects enrolled in the main study are eligible to participate in the sub-study. Interested subjects will participate in a separate informed consent process before participating in sub-study procedures.

Telephone Assessments

A research staff member will ask each sub-study subject two questions about how much the subject agrees with certain statements about his/her sleep, as well as two questions about how confident the subject is about carrying our certain sleep behaviors. These questions will be asked during the pre-treatment assessment period, 4-week assessment period, post-treatment assessment period, and the assessment period that takes place 3 months following the end of treatment.

Sleep Diary

Three times during his/her participation in the sub-study, study investigators will ask the subject to keep a sleep diary: once following enrollment but prior to randomization, once following the end of treatment, and once three months following the end of treatment. The subject will complete a diary entry twice a day (morning and night) for seven days. In the morning, the subject would answer basic questions about his/her sleep during the previous night, including time the subject thinks s/he fell asleep, the quality of his/her sleep, and any other experiences that might have affected his/her sleep. In the evening, the subject will answer questions about how the subject felt that day, any problems s/he experienced such as illness or discomfort, and basic activities s/he participated in like going to work, napping, drinking caffeinated beverages, etc.

Also, the subject will be instructed to call a toll free number twice a day to report when s/he woke up in the morning, and when s/he is going to sleep in the evening.

Actigraphy Device

Three times during his/her participation in the sub-study, study investigators will ask the subject to wear a sleep monitor device called an Actigraph: once following enrollment but prior to randomization, once following the end of treatment, and once three months following the end of treatment. The subject would wear the actigraph (Actiwatch , Philips Respironics, Bend, OR) like a wrist watch on his/her non-dominant arm. The device will measure how long the subject sleeps, as well as the overall quality of his/her sleep. The subject will wear the actigraph at all times during the same 7-day period s/he is completing the sleep diary except for when the subjects is participating in activities that might get the actigraph wet like swimming, showering, or bathing.

Study Design

• Study Type: Interventional
• Actual Enrollment: 343 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Hypnosis and Meditation for Pain Management in Veterans: Efficacy and Mechanisms
• Actual Study Start Date: Oct 9, 2015
• Actual Primary Completion Date: Mar 30, 2020
• Actual Study Completion Date: Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: PsychoEducation; Condition #1
Experimental: 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).	Behavioral: Self-Hypnosis Training; Condition #2
Experimental: 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.	Behavioral: Mindfulness Meditation; Condition #3

Outcome Measures

Primary Outcome Measures

1. Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale Immediately Following End of Treatment (Post-Treatment) [Change in Average Pain Intensity from Pre-Treatment to Immediately Following End of Approximately Eight Weeks of Treatment (Post-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 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.

Other Outcome Measures

1. Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale 3 Months Following End of Treatment [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.

2. Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale 6 Months Following End of Treatment [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18 years of age or older;

2. Veteran eligible for services through Veteran Health Affairs;

3. experience moderate to severe chronic pain on a regular basis; and

4. able to read, speak and understand English.

Exclusion Criteria:

1. severe cognitive impairment;

2. current or history of psychiatric or behavioral issues that require immediate attention and/or prevent the subject from participating effectively in the study;

3. reported use of a high dose of an opioid(s).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington, Ninth and Jefferson Building	Seattle	Washington	United States	98104
2	University of Washington- Harborview Medical Center	Seattle	Washington	United States	98104
3	VA Puget Sound Health Care System, Seattle Division	Seattle	Washington	United States	98108
4	University of Washington, Integrated Brain Imaging Center	Seattle	Washington	United States	98195
5	VA Puget Sound Health Care System, American Lake	Tacoma	Washington	United States	98493

Sponsors and Collaborators

• University of Washington
• VA Puget Sound Health Care System
• Washington State University

Investigators

• Principal Investigator: Mark Jensen, PhD, University of Washington
• Principal Investigator: Rhonda Williams, PhD, VA Puget Sound Healthcare System (VAPSHCS)

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 9, 2020
• Informed Consent Form - Mar 22, 2019

More Information

Publications

None provided.

• Responsible Party: Mark Jensen, Professor, Rehabilitation Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT02653664
• Other Study ID Numbers: 49799
• First Posted: Jan 12, 2016
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mark Jensen, Professor, Rehabilitation Medicine, University of Washington: Chronic Pain; Sleep
• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Arm/Group Title	Condition #1: PsychoEducation (ED)	Condition #2:Self-Hypnosis Training (HYP)	Condition #3: Mindfulness Meditation (MM)
Arm/Group Description	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	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	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
Period Title: Post-Treatment
STARTED	110	110	108
Primary and Secondary Data	93	104	91
Primary Outcome Data Only	3	0	3
COMPLETED	96	104	94
NOT COMPLETED	14	6	14
Period Title: Post-Treatment
STARTED	110	110	108
Primary and Secondary Data	83	95	82
Primary Outcome Data Only	6	0	1
COMPLETED	89	95	83
NOT COMPLETED	21	15	25
Period Title: Post-Treatment
STARTED	110	110	108
Primary and Secondary Outcome Data	85	87	83
Primary Outcome Data Only	2	2	2
COMPLETED	87	89	85
NOT COMPLETED	23	21	23

Baseline Characteristics

Arm/Group Title	Condition #1: PsychoEducation	Condition #2:Self-Hypnosis Training	Condition #3: Mindfulness Meditation	Total
Arm/Group Description	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	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	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 of all reporting groups
Overall Participants	110	110	108	328
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.5 (13.5)	51.0 (12.6)	55.0 (13.0)	53.2 (13.1)
Sex/Gender, Customized (Count of Participants)
Men	80 72.7%	81 73.6%	80 74.1%	241 73.5%
Women	27 24.5%	29 26.4%	28 25.9%	84 25.6%
Transgender	3 2.7%	0 0%	0 0%	3 0.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 5.5%	10 9.1%	14 13%	30 9.1%
Not Hispanic or Latino	101 91.8%	97 88.2%	91 84.3%	289 88.1%
Unknown or Not Reported	3 2.7%	3 2.7%	3 2.8%	9 2.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 3.6%	2 1.8%	2 1.9%	8 2.4%
Asian	3 2.7%	2 1.8%	4 3.7%	9 2.7%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.9%	1 0.9%	2 0.6%
Black or African American	19 17.3%	23 20.9%	16 14.8%	58 17.7%
White	68 61.8%	71 64.5%	68 63%	207 63.1%
More than one race	11 10%	5 4.5%	13 12%	29 8.8%
Unknown or Not Reported	5 4.5%	6 5.5%	4 3.7%	15 4.6%
Education Level (Count of Participants)
High School or Less	11 10%	9 8.2%	6 5.6%	26 7.9%
Some College/Technical	48 43.6%	54 49.1%	52 48.1%	154 47%
College Degree or Higher	51 46.4%	47 42.7%	50 46.3%	148 45.1%
Employment Status (Count of Participants)
Unemployed	54 49.1%	48 43.6%	36 33.3%	138 42.1%
Retired	45 40.9%	42 38.2%	47 43.5%	134 40.9%
Employed Full/Part Time	26 23.6%	32 29.1%	30 27.8%	88 26.8%
Student Full/Part Time	4 3.6%	4 3.6%	9 8.3%	17 5.2%
Home Maker	6 5.5%	7 6.4%	4 3.7%	17 5.2%
Married, Living with Partner (Count of Participants)
Count of Participants [Participants]	67 60.9%	60 54.5%	55 50.9%	182 55.5%
Homeless in Past Six Months (Count of Participants)
Count of Participants [Participants]	3 2.7%	3 2.7%	2 1.9%	8 2.4%
Type of Pain (Count of Participants)
Probable Neuropathic	58 52.7%	53 48.2%	49 45.4%	160 48.8%
Probable Non-Neuropathic	27 24.5%	26 23.6%	27 25%	80 24.4%
Uncertain	25 22.7%	31 28.2%	32 29.6%	88 26.8%
Very Good/ Excellent Health (Count of Participants)
Count of Participants [Participants]	12 10.9%	8 7.3%	12 11.1%	32 9.8%
Prior Pain Education (Count of Participants)
Count of Participants [Participants]	50 45.5%	42 38.2%	36 33.3%	128 39%
Prior Experience in Hypnosis (Count of Participants)
Count of Participants [Participants]	17 15.5%	24 21.8%	27 25%	68 20.7%
Prior Experience in Meditation (Count of Participants)
Count of Participants [Participants]	64 58.2%	63 57.3%	62 57.4%	189 57.6%
Average Pain Intensity (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	5.8 (1.6)	5.7 (1.8)	5.9 (1.6)	5.8 (1.7)
Worst Pain Intensity (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	7.3 (1.6)	7.0 (1.8)	7.2 (1.6)	7.2 (1.7)
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Instrument (T-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [T-score]	64.6 (5.0)	63.4 (5.0)	64.0 (5.8)	64.0 (5.3)
PROMIS Sleep Disturbance Instrument (T-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [T-score]	59.2 (8.5)	59.0 (8.5)	57.9 (9)	58.7 (8.7)
PROMIS Anxiety Instrument (T-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [T-score]	58.4 (8.9)	57.0 (9.5)	57.2 (9.3)	57.5 (9.2)
PROMIS Depression Instrument (T-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [T-score]	55.6 (8.8)	54.1 (9.3)	53.4 (8.9)	54.4 (9.0)
Posttraumatic Stress Disorder Checklist (PCL-5) Score (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	34.3 (17.4)	32.6 (18.6)	31.4 (17.3)	32.8 (17.8)
Classified As Having PTSD (Count of Participants)
Count of Participants [Participants]	63 57.3%	53 48.2%	49 45.4%	165 50.3%
Any Opioid Analgesic Use, Baseline (Count of Participants)
Count of Participants [Participants]	35 31.8%	19 17.3%	30 27.8%	84 25.6%
Morphine Equivalent Dose (milligrams, morphine equivalent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milligrams, morphine equivalent]	6.0 (15.3)	5.9 (20.6)	6.3 (16.1)	6.2 (17.5)

Outcome Measures

1. Primary Outcome

Title	Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale Immediately Following End of Treatment (Post-Treatment)
Description	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.
Time Frame	Change in Average Pain Intensity from Pre-Treatment to Immediately Following End of Approximately Eight Weeks of Treatment (Post-Treatment)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Condition #1: PsychoEducation (ED)	Condition #2:Self-Hypnosis Training (HYP)	Condition #3: Mindfulness Meditation (MM)
Arm/Group Description	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	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	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
Measure Participants	110	110	108
Mean (95% Confidence Interval) [score on a scale]	-.57	-.61	-.85

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Condition #1: PsychoEducation (ED), Condition #2:Self-Hypnosis Training (HYP), Condition #3: Mindfulness Meditation (MM)
	Comments	Based on our prior work comparing similar interventions, assuming decreases in average pain intensity of 0.3 points (on a 0-10 scale) for ED, between 0.8 to 1.4 points for HYP, and between 0.6 to 1 for MM, with standard deviations (SD) ranging from 0.15 to 1, significance level of 0.05, and using ANOVA as the statistical method, we calculated that 80 participants per arm at immediate post-treatment would provide at least 80% power to detect between-groups differences as specified.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.39
	Comments	Statistical significance was set at p=.05
	Method	ANOVA
	Comments

2. Other Pre-specified Outcome

Title	Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale 3 Months Following End of Treatment
Description	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.
Time Frame	Change in Average Pain Intensity from Pre-Treatment to 3 Months Following End of Treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Condition #1: PsychoEducation	Condition #2:Self-Hypnosis Training	Condition #3: Mindfulness Meditation
Arm/Group Description	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	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	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
Measure Participants	110	110	108
Mean (95% Confidence Interval) [score on a scale]	-.48	-.95	-.67

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Condition #1: PsychoEducation (ED), Condition #2:Self-Hypnosis Training (HYP), Condition #3: Mindfulness Meditation (MM)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.05
	Comments	Statistical significance was set at p=.05.
	Method	ANOVA
	Comments

3. Other Pre-specified Outcome

Title	Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale 6 Months Following End of Treatment
Description	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.
Time Frame	Change in Average Pain Intensity from Pre-Treatment to 6 Months Following End of Treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Condition #1: PsychoEducation	Condition #2:Self-Hypnosis Training	Condition #3: Mindfulness Meditation
Arm/Group Description	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	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	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
Measure Participants	110	110	108
Mean (95% Confidence Interval) [score on a scale]	-.28	-1.04	-.86

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Condition #1: PsychoEducation (ED), Condition #2:Self-Hypnosis Training (HYP), Condition #3: Mindfulness Meditation (MM)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	Statistical significance was set at p= .05
	Method	ANOVA
	Comments

Adverse Events

Time Frame	Adverse event data were collected for each subject following enrollment until study completion, approximately 9-12 months.
Arm/Group Title	Condition #1: PsychoEducation		Condition #2:Self-Hypnosis Training		Condition #3: Mindfulness Meditation
Arm/Group Description	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		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		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
All Cause Mortality
	Condition #1: PsychoEducation		Condition #2:Self-Hypnosis Training		Condition #3: Mindfulness Meditation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/110 (0%)		0/110 (0%)		0/108 (0%)
Serious Adverse Events
	Condition #1: PsychoEducation		Condition #2:Self-Hypnosis Training		Condition #3: Mindfulness Meditation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/110 (20%)		12/110 (10.9%)		18/108 (16.7%)
Blood and lymphatic system disorders
Inpatient Hospitalization, Unrelated to Study Procedures	0/110 (0%)	0	0/110 (0%)	0	1/108 (0.9%)	1
Cardiac disorders
Inpatient Hospitalization, Unrelated to Study Procedures	1/110 (0.9%)	1	1/110 (0.9%)	2	1/108 (0.9%)	1
Gastrointestinal disorders
Inpatient Hospitalization, Unrelated to Study Procedures	1/110 (0.9%)	1	0/110 (0%)	0	0/108 (0%)	0
General disorders
New/Unusual/ Worsening Pain or Physical Discomfort At Least Possibly Related to Study Procedures	1/110 (0.9%)	1	0/110 (0%)	0	0/108 (0%)	0
Medically Important Surgery or Medical Procedure, Unrelated to Study Procedures	13/110 (11.8%)	15	5/110 (4.5%)	5	6/108 (5.6%)	8
New Cancer Diagnosis, Unrelated to Study Procedures	1/110 (0.9%)	1	0/110 (0%)	0	0/108 (0%)	0
Inpatient Hospitalization, Unrelated to Study Procedures	1/110 (0.9%)	1	3/110 (2.7%)	3	3/108 (2.8%)	3
New/Unusual/ Worsening Pain or Physical Discomfort Unrelated to Study Procedures	0/110 (0%)	0	1/110 (0.9%)	1	0/108 (0%)	0
Injury, poisoning and procedural complications
New Physical Injury, Unrelated to Study Procedures	2/110 (1.8%)	3	2/110 (1.8%)	2	3/108 (2.8%)	3
Inpatient Hospitalization, Unrelated to Study Procedures	0/110 (0%)	0	1/110 (0.9%)	1	1/108 (0.9%)	1
Nervous system disorders
Seizures, Unrelated to Study Procedures	1/110 (0.9%)	1	0/110 (0%)	0	0/108 (0%)	0
Psychiatric disorders
Life Threatening Suicidal Ideation/Attempt, Unrelated to Study Procedures	0/110 (0%)	0	0/110 (0%)	0	2/108 (1.9%)	3
Homicidal Ideation, Unrelated to Study Procedures	0/110 (0%)	0	1/110 (0.9%)	1	0/108 (0%)	0
Inpatient Hospitalization, Unrelated to Study Procedures	1/110 (0.9%)	1	0/110 (0%)	0	1/108 (0.9%)	1
Renal and urinary disorders
Inpatient Hospitalization, Unrelated to Study Procedures	0/110 (0%)	0	0/110 (0%)	0	1/108 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Inpatient Hospitalization, Unrelated to Study Procedures	1/110 (0.9%)	1	1/110 (0.9%)	1	0/108 (0%)	0
Other (Not Including Serious) Adverse Events
	Condition #1: PsychoEducation		Condition #2:Self-Hypnosis Training		Condition #3: Mindfulness Meditation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	73/110 (66.4%)		63/110 (57.3%)		69/108 (63.9%)
General disorders
New Physical Injury, Unrelated to Study Procedures	9/110 (8.2%)	10	13/110 (11.8%)	15	15/108 (13.9%)	20
New/Unusual/ Worsening Nausea, At Least Possibly Related to EEG Procedures	1/110 (0.9%)	1	0/110 (0%)	0	0/108 (0%)	0
New/Unusual/ Worsening Nausea, At Least Possibly Related to Treatment Procedures	0/110 (0%)	0	1/110 (0.9%)	1	0/108 (0%)	0
New/Unusual/ Worsening Nausea, Unrelated to Study Procedures	0/110 (0%)	0	0/110 (0%)	0	1/108 (0.9%)	1
Adverse Medication Reaction, Unrelated to Study Procedures	1/110 (0.9%)	1	2/110 (1.8%)	2	4/108 (3.7%)	4
New Diagnosis, Not Life Threatening, Unrelated to Study Procedures	0/110 (0%)	0	1/110 (0.9%)	1	1/108 (0.9%)	1
New Illness/Infection/Untoward Medical Occurrence Unrelated to Study Procedures	35/110 (31.8%)	60	31/110 (28.2%)	60	28/108 (25.9%)	41
New Illness/Infection/Untoward Medical Occurrence, At Least Possibly Related to Treatment Procedures	0/110 (0%)	0	2/110 (1.8%)	2	0/108 (0%)	0
New/Unusual/ Worsening Cognitive Difficulties, Unrelated to Study Procedures	0/110 (0%)	0	1/110 (0.9%)	1	1/108 (0.9%)	2
New/Unusual/ Worsening Fatigue, Unrelated to Study Procedures	3/110 (2.7%)	3	4/110 (3.6%)	5	4/108 (3.7%)	4
New/Unusual/ Worsening Headache/Migraine, At Least Possibly Related to Study Self-Report Measures	0/110 (0%)	0	0/110 (0%)	0	1/108 (0.9%)	1
New/Unusual/ Worsening Headache/Migraine, At Least Possibly Related to EEG Procedures	0/110 (0%)	0	1/110 (0.9%)	1	0/108 (0%)	0
New/ Worsening Headache/Migraine, At Least Possibly Related to Baseline Hypnotizability Assessment	0/110 (0%)	0	1/110 (0.9%)	1	0/108 (0%)	0
New/Unusual/ Worsening Headache/Migraine, Unrelated to Study Procedures	10/110 (9.1%)	11	10/110 (9.1%)	16	5/108 (4.6%)	7
New/Unusual/ Worsening Pain or Physical Discomfort Unrelated to Study Procedures	23/110 (20.9%)	36	21/110 (19.1%)	34	23/108 (21.3%)	42
New/Worsening Psych. Discomfort At Least Possibly Related to Baseline Hypnotizability Assessment	2/110 (1.8%)	2	4/110 (3.6%)	4	6/108 (5.6%)	6
New/Worsening Psychological Discomfort At Least Possibly Related to Study Procedures, General	1/110 (0.9%)	1	0/110 (0%)	0	0/108 (0%)	0
New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to EEG Procedures	2/110 (1.8%)	2	6/110 (5.5%)	6	3/108 (2.8%)	3
New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to Self-Report Measures	1/110 (0.9%)	1	3/110 (2.7%)	3	4/108 (3.7%)	5
New/Unusual/ Worsening Psychological Discomfort At Least Possibly Related to Treatment Procedures	1/110 (0.9%)	1	7/110 (6.4%)	8	3/108 (2.8%)	3
New/Unusual/ Worsening Psychological Discomfort, Unrelated to Study Procedures	7/110 (6.4%)	8	12/110 (10.9%)	16	11/108 (10.2%)	11
New/Worsening Skin Irritation, At Least Possibly Related to Wearing Sleep Sub-Study Actigraph Device	1/110 (0.9%)	1	5/110 (4.5%)	6	1/108 (0.9%)	1
New/Unusual/ Worsening Sleep Problems, At Least Possibly Related to Sleep Sub-Study Procedures	0/110 (0%)	0	0/110 (0%)	0	1/108 (0.9%)	1
New/Unusual/ Worsening Sleep Problems, At Least Possibly Related to Treatment Procedures	1/110 (0.9%)	1	0/110 (0%)	0	0/108 (0%)	0
New/Unusual/ Worsening Sleep Problems Unrelated to Study Procedures	2/110 (1.8%)	2	5/110 (4.5%)	5	3/108 (2.8%)	3
New/Worsening Pain, Phys. Discomfort at Least Possibly Related to Baseline Hypno. Assessment	7/110 (6.4%)	7	3/110 (2.7%)	3	2/108 (1.9%)	2
New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to Consent Session	0/110 (0%)	0	2/110 (1.8%)	2	0/108 (0%)	0
New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to EEG Procedures	8/110 (7.3%)	8	3/110 (2.7%)	3	4/108 (3.7%)	5
New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to Self-Report Measures	0/110 (0%)	0	0/110 (0%)	0	1/108 (0.9%)	1
New/Unusual/Worsening Pain or Physical Discomfort at Least Possibly Related to Treatment Procedures	1/110 (0.9%)	1	7/110 (6.4%)	7	8/108 (7.4%)	8
Non-Life Threatening Suicidal Ideation, Unrelated to Study Procedures	1/110 (0.9%)	1	0/110 (0%)	0	1/108 (0.9%)	1
Non-Life Threatening/ Outpatient Surgery or Medical Procedure, Unrelated to Study Procedures	22/110 (20%)	24	14/110 (12.7%)	20	18/108 (16.7%)	25

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.