Musculoskeletal PainLIFENCT03916276

Living in Full Even With Pain Study

A study testing Cognitive Therapy (CT), Mindfulness Meditation (MM) and Behavioral Activation (BA) in people with Musculoskeletal Pain and Chronic Pain, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Musculoskeletal Pain, Chronic Pain
What is being tested?: Cognitive Therapy (CT), Mindfulness Meditation (MM) and Behavioral Activation (BA)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 1 siteUnited States
Study dates: 16 Jun 2020to 25 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years;
Meet criteria for having a chronic pain problem (≥3 months, with pain experienced on ≥50% of days in past 6 months);
Use of opioid medication in the past week;
Daily average opioid analgesic medication use in the past week of ≥20 MMEs;
Average intensity of chronic pain ≥3 on a 10-point scale for most days of the previous 3 months;
Able to read, speak, and understand English; and
Availability of a telephone, webcam, and microphone through computer or telephone, as well as daily internet access.

Who cannot join

Primary pain condition is headache;
Severe cognitive impairment;
Current alcohol or substance dependence;
Active malignancy (e.g., cancer not in remission), terminal illnesses, or serious medical conditions that may interfere with either study participation or with receiving potential treatment benefits (e.g., severe lupus);
Inability to walk (defined as unable to walk at least 50 yards), which would limit the ability of participants to benefit from the activation skills intervention;
Significant pain from a recent surgery or injury;

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Pain condition for which surgery has been recommended and is planned;
Any planned surgery, procedure, hospitalization, treatment, or event that may conflict with or otherwise influence participation in the study;
Currently receiving or had received other psychosocial treatments for any pain condition;
Current or past participation in a research study with treatment components that may overlap, conflict, or affect those in the current study;
Current or history of diagnosis of primary psychotic or major thought disorder within the past 5 years;
Psychiatric hospitalization within the past 6 months;
Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months;
Any psychiatric or behavioral issues as noted in the medical record or disclosed/observed during self-report screening that would indicate participant may be inappropriate in a group setting; and
Presenting symptoms at the time of screening that would interfere with participation, specifically active suicidal or homicidal ideation with intent to harm oneself or others or active delusional or psychotic thinking.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington, Ninth and Jefferson Building
Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Mechanisms of Psychosocial Treatments on Opioid Use in Chronic Pain

This project will increase our understanding of the mechanisms underlying changes in opioid medication use associated with three psychosocial chronic pain (CP) treatments. These treatments are: (1) Cognitive Therapy (CT), (2) Mindfulness Meditation (MM), and (3) Behavioral Activation (BA). The sample will be adults with CP who are at risk of opioid misuse. The purpose of this study is to understand the specific ways these treatments work for reducing opioid use. In addition, the investigators are interested in examining moderators of treatment response. The findings will potentially inform the future streamlining of psychosocial treatments, as well as the development of algorithms for matching individuals with CP who are at risk for opioid misuse to the specific treatment most likely to efficiently optimize benefit.

Read the detailed description

This study involves participating in eight videoconference group treatment sessions and telephone interviews over the course of approximately eight to nine months. All study procedures will take place over videoconferencing computer software, online, or by telephone. There are no in-person visits for the study. Participants wear an activity monitor for about two and a half months starting two weeks before treatment begins. They will also complete brief online surveys twice a day, once in the morning and once in the evening, for about two and a half months starting two weeks before treatment begins. These surveys will be completed on a computer, tablet, or smartphone.

Extended Assessments

During the study, participants would also complete four extended assessments with a research staff member. The first interview is completed before treatment begins, the second is completed after treatment ends, the third is completed three months after treatment ends, and the fourth and final is completed six months after treatment ends. The first two extended assessments (Pre- and Post-Treatment) are completed with a research staff member verbally over the telephone. The final two extended assessments (3-month and 6-month Follow-up) may be completed either with a research staff member verbally over the telephone or independently online.

Online Surveys

About two weeks before treatment starts, participants begin doing brief (~2-5 minutes) online surveys twice a day. The online surveys can be completed on a smartphone, tablet, laptop, or desktop computer. Automated notifications in the morning and in the evening remind the participant to complete the brief survey twice a day.

Activity Monitor

Participants wear an activity monitor 24 hours a day for the 2.5-month Monitoring Period (which spans two weeks before treatment to one month after treatment). The activity monitor is worn on the non-dominant wrist, like a wristwatch.

Weekly Interviews

Beginning two weeks prior to treatment, participants will be contacted weekly by a staff member to complete a telephone survey. Participants complete 10 total surveys over the course of 10 weeks, concluding about one month after treatment ends. Each survey takes approximately 10-15 minutes.

Treatment

Participants are randomly assigned to one of the three treatment groups. Treatment consists of eight group treatment sessions completed remotely over a videoconferencing platform. There will be, on average, two sessions per week, and each session will take up to 90 minutes. Each treatment session will take place over the internet on a computer, tablet, or smartphone using the videoconference application. Each session will be led by the same study clinician, who is a trained clinical psychologist. Participants will be required to use a video camera and audio through either a microphone or phone for each group treatment session.

All three treatment interventions will involve educating participants about pain, discussing the impact of pain, and discussing different ways to manage it in hopes of decreasing pain and its impact. The three treatments are: (1) Mindfulness Meditation, (2) Cognitive Therapy, and (3) Behavioral Activation (BA).

Each treatment intervention will have home practice activities to complete between sessions. Home practice activities may include, but are not limited to, creating thought records, listening to pre-recorded guided practices, and keeping track of activities and goals. Participants also receive a treatment workbook with materials to refer to and discuss during the group sessions as well as additional materials to read between sessions.

Conditions: Musculoskeletal Pain, Chronic Pain
Being tested: Cognitive Therapy (CT), Mindfulness Meditation (MM), Behavioral Activation (BA)
Keywords: Chronic Pain, Opioid, Heterogeneous Pain, Musculoskeletal Pain, Mindfulness Meditation, Behavioral Activation, Cognitive Therapy, Telehealth, Opioid Misuse, Mechanisms
Medical subject headings: Musculoskeletal Pain, Chronic Pain, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03916276
Study group	Role	What they receive
Cognitive Therapy (CT) Condition	Active comparator	Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Receives: Behavioral: Cognitive Therapy (CT)
Mindfulness Meditation (MM) Condition	Active comparator	Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Receives: Behavioral: Mindfulness Meditation (MM)
Behavioral Activation (BA) Condition	Active comparator	Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Receives: Behavioral: Behavioral Activation (BA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Morphine Milligram Equivalent (MME) Average Daily Dose
Respondents were asked to provide dosages and frequency of use of any opioid medications taken in the past seven days at the time of each telephone assessment. An average daily MME dose taken in the past week was computed for each assessment point, and a categorical variable was calculated to assess change throughout the trial (increase dose, decrease dose, no change).
Measured: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

Secondary outcomes (6)

Change in Pain Interference (Micro-level)
Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed and converted to a total T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Measured: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Change in Affect (Micro-level)
Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Measured: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Change in Physical Function
Change in extent of physical function will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form-4A. Responses are summed and the raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of physical function. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Measured: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Change in Sleep Quality
Change in sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form-4A. Responses from each item will be summed. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported sleep disturbance. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Measured: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Change in Pain Interference (Macro-level)
Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed and converted to a total T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Measured: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Change in Affect (Macro-level)
Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed via phone, responses from the positive affect items will be summed for a total positive score ranging from 5-25 while responses from the negative affect items will be separately summed for a total negative score ranging from 5-25. When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
Measured: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jun 202025 Jan 2023

First posted16 Apr 2019
Study start16 Jun 2020
Primary completion25 Jan 2023
Study completion25 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A randomized 3-group, 90-subject clinical trial to test the mediators and moderators of cognitive therapy, mindfulness meditation, and behavioral activation on individuals with heterogeneous chronic pain conditions who are at risk for opioid misuse.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03916276
Sponsor's protocol ID: STUDY00006474
Other IDs: R01AT008559-02S1
Acronym: LIFE
Status last verified: May 2026
First submitted: 12 Apr 2019
Last updated: 25 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We will make available to interested researchers a data file containing de-identified data used for each published article at the time the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, we will create a data file that includes all variables used in the published article and a list of the variables in the data file (along with variable labels) and mail to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) a CD of the data set (as an SPSS.sav file). Note, though, even though any data files that we share will be stripped of identifiers prior to release for sharing, it remains possible those who access the data could potentially use deduction to identify participants with unusual characteristics or combinations of unusual characteristics.

Publications

Day MA, Ciol MA, Ehde DM, Mendoza ME, Borckardt J, Newman AK, Chan JF, Friedly JL, Reed DE 2nd, Drever SA, Burns J, Thorn BE, Jensen MP. The Effects of Psychological Treatments for Chronic Pain on Reducing Opioid Use in People at Risk for Opioid Misuse: A Randomized Feasibility Trial. Pain Pract. 2026 Jan;26(1):e70107. doi: 10.1111/papr.70107.
PubMed 41230568

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Musculoskeletal Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanisms of Psychosocial Treatments on Opioid Use in Chronic Pain
ClinicalTrials.gov ID: NCT03916276
Acronym / sponsor ID: LIFE / STUDY00006474
Conditions: Musculoskeletal Pain, Chronic Pain
Keywords: Chronic Pain, Opioid, Heterogeneous Pain, Musculoskeletal Pain, Mindfulness Meditation, Behavioral Activation, Cognitive Therapy, Telehealth
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH), The University of Queensland, Medical University of South Carolina, Rush University
Study start: 16 Jun 2020 (actual)
Primary completion: 25 Jan 2023 (actual)
Study completion: 25 Jan 2023 (actual)
First posted: 16 Apr 2019 (actual)
Results: Posted 13 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Extended Assessments

Online Surveys

Activity Monitor

Weekly Interviews

Treatment

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: A randomized 3-group, 90-subject clinical trial to test the mediators and moderators of cognitive therapy, mindfulness meditation, and behavioral activation on individuals with heterogeneous chronic pain conditions who are at risk for opioid misuse.

Arm	Type	Receives
Cognitive Therapy (CT) Condition	Active comparator	Behavioral: Cognitive Therapy (CT)Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.
Mindfulness Meditation (MM) Condition	Active comparator	Behavioral: Mindfulness Meditation (MM)Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events.
Behavioral Activation (BA) Condition	Active comparator	Behavioral: Behavioral Activation (BA)Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age ≥18 years;
Meet criteria for having a chronic pain problem (≥3 months, with pain experienced on ≥50% of days in past 6 months);
Use of opioid medication in the past week;
Daily average opioid analgesic medication use in the past week of ≥20 MMEs;
Average intensity of chronic pain ≥3 on a 10-point scale for most days of the previous 3 months;

Key exclusion criteria (15 listed)

Primary pain condition is headache;
Severe cognitive impairment;
Current alcohol or substance dependence;
Active malignancy (e.g., cancer not in remission), terminal illnesses, or serious medical conditions that may interfere with either study participation or with receiving potential treatment benefits (e.g., severe lupus);
Inability to walk (defined as unable to walk at least 50 yards), which would limit the ability of participants to benefit from the activation skills intervention;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

Change in Morphine Milligram Equivalent (MME) Average Daily Dose
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Respondents were asked to provide dosages and frequency of use of any opioid medications taken in the past seven days at the time of each telephone assessment. An average daily MME dose taken in the past week was computed for each assessment point, and a categorical variable was calculated to assess change throughout the trial (increase dose, decrease dose, no change).

6 secondary outcomes

Change in Pain Interference (Micro-level)
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Change in Affect (Micro-level)
Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Change in Physical Function
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Change in Sleep Quality
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Change in Pain Interference (Macro-level)
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Change in Affect (Macro-level)
Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

Results and safety

Results posted to the registry on 13 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitive Therapy (CT) Condition	31	28
Mindfulness Meditation (MM) Condition	29	26
Activation Skills (AS) Condition	31	29

Primary outcome: Change in Morphine Milligram Equivalent (MME) Average Daily Dose

Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks). Number. Unit: participants

Measure	Cognitive Therapy (CT) Condition n = 28	Mindfulness Meditation (MM) Condition n = 26	Behavioral Activation (BA) Condition n = 29
Increase in dose from pre- to post-treatment	8	4	5
Increase in dose from pre- to 3 months post-treatment	5	4	4
Increase in dose from pre- to 6 months post-treatment	6	7	5
Decrease in dose from pre- to post-treatment	9	14	6
Decrease in dose from pre- to 3 months post-treatment	12	11	6
Decrease in dose from pre- to 6 months post-treatment	8	8	6
No change in dose from pre- to post-treatment	11	8	18
No change in dose from pre- to 3 months post-treatment	9	11	17

Cognitive Therapy (CT) Condition vs Mindfulness Meditation (MM) Condition vs Behavioral Activation (BA) Condition: p >.05, Chi-squared

Population analysed: Intent to treat

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cognitive Therapy (CT) Condition	2 of 31 (6.5%)	15 of 31 (48.4%)	0 of 31
Mindfulness Meditation (MM) Condition	0 of 29 (0%)	15 of 29 (51.7%)	0 of 29
Behavioral Activation (BA) Condition	4 of 31 (12.9%)	19 of 31 (61.3%)	1 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 41230568Day MA, Ciol MA, Ehde DM, Mendoza ME, Borckardt J, Newman AK, Chan JF, Friedly JL, Reed DE 2nd, Drever SA, Burns J, Thorn BE, Jensen MP. The Effects of Psychological Treatments for Chronic Pain on Reducing Opioid Use in People at Risk for Opioid Misuse: A Randomized Feasibility Trial. Pain Pract. 2026 Jan;26(1):e70107. doi: 10.1111/papr.70107.
Study websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. We will make available to interested researchers a data file containing de-identified data used for each published article at the time the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, we will create a data file that includes all variables used in the published article and a list of the variables in the data file (along with variable labels) and mail to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) a CD of the data set (as an SPSS.sav file). Note, though, even though any data files that we share will be stripped of identifiers prior to release for sharing, it remains possible those who access the data could potentially use deduction to identify participants with unusual characteristics or combinations of unusual characteristics.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Jensen, Ph.D. principal investigator

University of Washington

Melissa Day, Ph.D. principal investigator

The University of Queensland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Morphine Milligram Equivalent (MME) Average Daily Dose (time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03916276, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.