CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 217 enrolled
Drug / intervention
Mindfulness-Based Stress Reduction +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/NCT04486066
NCT04486066N/ACompleted

An Evaluation of MBSR and CBT for Veterans With Chronic Pain

VA Office of Research and Development·interventional·Posted Jul 24, 2020·Updated Jun 25, 2025

In Brief

A clinical study evaluating Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy for Chronic Pain, and 1 other intervention for Chronic Pain and Pain. Completed, enrolled 217 participants across 1 site.

Detailed Summary

Approximately fifty percent of Veterans report chronic pain. Management of chronic pain is often compounded by other life problems, including depression and posttraumatic stress disorder. Use of opioids for pain management entails risk of harm, and effective non-pharmacologic approaches to chronic pain management are needed. Mindfulness-Based Stress Reduction (MBSR) and group Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) are programs that teach skills to improve functionality and quality of life for people with chronic pain. However, studies of MBSR and the group form of CBT-CP for chronic pain remain limited. In the proposed trial, MBSR will be compared to CBT-CP and usual care, with assessment of pain interference and other outcomes at 6-month follow-up. If MBSR and group CBT-CP are shown to be effective in improving outcomes, it would support use of these modalities for chronic pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain, Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 24, 2020
Enrollment StartJan 27, 2021
Primary CompletionMay 1, 2024
Study CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.9 years ago

Interventions

Mindfulness-Based Stress Reductionbehavioral

In MBSR, participants meet by video for 2 hours per week for 8 weeks in a group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.

Cognitive Behavioral Therapy for Chronic Painbehavioral

Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 video sessions in a group format, while retaining all essential elements.

Usual Careother

Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.