N/A N=217 Randomized Treatment

An Evaluation of MBSR and CBT for Veterans With Chronic Pain

Chronic Pain · Pain

Bottom Line

View on ClinicalTrials.gov: NCT04486066 ↗

Enrolled (actual)

217

Serious AEs

0.9%

Results posted

Jun 2025

Primary outcome: Primary: Pain Interference Subscale of Brief Pain Inventory (BPI) — 4.7; 4.8; 4.9; 4.4 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mindfulness-Based Stress Reduction (Behavioral); Cognitive Behavioral Therapy for Chronic Pain (Behavioral); Usual Care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Interference Subscale of Brief Pain Inventory (BPI)	4.7; 4.8; 4.9; 4.4; 3.7; 4.8	—

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.

Eligibility Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04486066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.