CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 91 enrolled / 91 target
Drug / intervention
Cognitive Therapy (CT) +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03916276
NCT03916276N/ACompletedOn Track (1.3/mo)Completion was 41mo ago

Mechanisms of Psychosocial Treatments on Opioid Use in Chronic Pain

University of Washington·interventional·Posted Apr 16, 2019·Updated Jun 25, 2026

In Brief

A clinical study evaluating Cognitive Therapy (CT), Mindfulness Meditation (MM), and 1 other intervention for Musculoskeletal Pain and Chronic Pain. Completed, enrolled 91 participants across 1 site.

Detailed Summary

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.

Study Details

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 16, 2019
Enrollment StartJun 16, 2020
Primary CompletionJan 25, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.2 years ago

Arms & Interventions

Cognitive Therapy (CT) Conditionactive_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.

Behavioral: Cognitive Therapy (CT)
Mindfulness Meditation (MM) Conditionactive_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.

Behavioral: Mindfulness Meditation (MM)
Behavioral Activation (BA) Conditionactive_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.

Behavioral: Behavioral Activation (BA)

Interventions

Cognitive Therapy (CT)behavioral

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)behavioral

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)behavioral

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.