An Evaluation of MBSR and CBT for Veterans With Chronic Pain

NCT04486066 | Completed Results

• 2 other identifiers: D3283-RIO1RX003283-01A2
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Pain

Keywords

mindfulness; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Pain Interference Subscale of Brief Pain Inventory (BPI)

  The primary outcome is the Brief Pain Inventory Short Form Interference subscale (BPI). This is a 7-item scale that assesses the extent to which pain interferes with activities in daily life, such as general activity, mood, walking ability, work, relations with other people, sleep, and enjoyment of life. Scores range from 0 to 10 with higher scores indicating greater pain interference.

  Baseline, Immediate post-treatment, 6 months after completing treatment

Study Arms (3)

Mindfulness-Based Stress Reduction (MBSR)

EXPERIMENTAL

In MBSR, participants meet for 2 hours per week for 8 weeks in a video 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.

Behavioral: Mindfulness-Based Stress Reduction

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

EXPERIMENTAL

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 sessions in a video group format, while retaining all essential elements.

Behavioral: Cognitive Behavioral Therapy for Chronic Pain

Usual Care

OTHER

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.

Other: Usual Care

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

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.

Mindfulness-Based Stress Reduction (MBSR)

Cognitive Behavioral Therapy for Chronic Pain BEHAVIORAL

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.

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants must meet criteria for chronic musculoskeletal pain, defined as:
• musculoskeletal pain of low back
• cervical spine, or extremities (hip, knee, or shoulder)
• pain for at least 3 months
• pain severity (worst or average pain score equal to or greater than 4)(i.e., score of 4 or greater on BPI items 3 or 5) and average pain interference (BPI items 9A-9G) rated equal to or great than 3 of 10 over prior week, as measured using the Brief Pain Inventory (BPI)

You may not qualify if:

• uncontrolled psychotic disorder
• current bipolar affective disorder with mania
• current suicidal or homicidal ideation with intent in the last month
• inpatient psychiatric admission within the past month
• severe medical conditions that would limit participation (e.g., Class III or IV heart failure)
• pending back surgery

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain

Interventions

Mindfulness-Based Stress Reduction; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Tracy Simpson
• Organization: VA Puget Sound

tracy.simpson@va.gov

(206) 277-3337

Study Officials

• Tracy L Simpson, PhD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: January 27, 2021
• Primary Completion: May 1, 2024
• Study Completion: September 30, 2024
• Last Updated: June 25, 2025
• Results First Posted: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)