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An Evaluation of MBSR and CBT for Veterans With Chronic Pain

CompletedNot applicableNCT04486066
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Official title
An Evaluation of MBSR and CBT for Veterans With Chronic Pain
Sponsor
VA Office of Research and Development
Start date
2021-01-27
Primary completion
2024-05-01
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 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) Exclusion Criteria: At baseline, the MINI psychiatric interview will determine psychiatric exclusion criteria: * 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 Additional exclusion criteria include prior formal participation in MBSR or CBT-CP. The investigators will include subjects with Alcohol Use Disorder (AUD; defined by the MINI) but exclude those for whom alcohol use poses a safety threat (defined as current drinking and a past-year history of alcohol-related seizures or delirium tremens). The investigators will also include those with Opioid Use Disorder (OUD) and other Substance Use Disorder (SUD; each defined by the MINI).

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04486066