N/A
N=184
Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functioning Among Veterans
Musculoskeletal Pain · Pain
Bottom Line
View on ClinicalTrials.gov: NCT04724694 ↗Enrolled (actual)
184
Serious AEs
3.3%
Results posted
Jan 2026
Primary outcome: Primary: Brief Pain Inventory -- Interference Subscale (BPI-I) to Assess 12 Week Follow-up — 4.58; 5.35 score on instrument — p=0.026
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief CBT for Chronic Pain (Behavioral); Treatment as usual (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory -- Interference Subscale (BPI-I) to Assess 12 Week Follow-up |
4.58; 5.35 | 0.026 sig |
| SECONDARY Brief Pain Inventory -- Pain Intensity Subscale (BPI-P) to Assess 12 Week Follow-up |
5.01; 5.43 | 0.124 |
| SECONDARY Patient Health Questionnaire -- 9 (PHQ-9) to Assess 12 Week Follow-up |
6.75; 8.10 | 0.746 |
| SECONDARY World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Physical Health at 12 Week Follow up |
13.016; 12.10 | 0.0002 sig |
| SECONDARY World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Psychological Quality of Life at 12 Week Follow up |
15.16; 13.85 | 0.046 sig |
| SECONDARY World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Social Relationships at 12 Week Follow up |
14.54; 13.85 | 0.161 |
| SECONDARY World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Environmental Health at 12 Week Follow up |
16.28; 15.67 | 0.719 |
| SECONDARY Ability to Participate in Social Roles and Activities - Short Form (APSRA) to Assess 12 Week Follow up |
28.32; 26.90 | 0.098 |
Summary
Chronic pain is very common among primary care Veterans and can seriously impact overall patient functioning and well-being. Currently, behavioral treatments for pain management are not often provided in primary care because they are designed to be delivered in specialty care settings, such as chronic pain clinics. To address this gap in care, the proposed study will test if Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is an effective treatment. Therefore, the first objective of the proposed study is to conduct a randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to assess treatment effectiveness by examining changes in pain-related physical activity interference, psychological distress, pain intensity, and other related outcomes. 178 eligible participants will be randomized into either Brief CBT-CP and primary care treatment as usual or primary care treatment as usual only. Eligible Veterans will include those with chronic musculoskeletal pain and pain-related functional impairment identified from primary care. Participants assigned to Brief CBT-CP will receive six sessions of treatment in 30-minute appointments. This intervention will include education and goal setting, activities and pacing, relaxation skills, cognitive coping, and relapse prevention. Assessments will include validated self-report measures that will take place at pre-treatment (baseline), mid-treatment, post-treatment, and at 6-month follow-up. The second objective of this study is examine the mechanisms by which Brief CBT-CP leads to improvement in patient outcomes. Statistical analysis will reveal if changes pain self-efficacy (i.e., perceived ability to manage pain or engage in usual activities despite being in pain) and catastrophizing (i.e., unhelpful, negative though patterns about pain and pain management) lead to improvements in patient functioning. The third objective of this study will be to explore perceptions of Brief CBT-CP among patients who experience significant improvement in outcomes compared to those who did not experience improvement. Participants will include up to 40 patients who were treated with Brief CBT-CP. Participants will be interviewed about key components of the treatment and their perception of effectiveness. Interview data will be compared to the results of statistical analysis to help understand the mechanisms by which Brief CBT-CP is effective or identify areas for improvement. Results of this study will provide information needed to determine if Brief CBT-CP should be widely disseminated across VA primary care clinics.
Eligibility Criteria
Inclusion Criteria
- Veterans age >=18 and three months
- PEG score of >= 4 on pain intensity item and both interference items at screening
- BPI interference and pain intensity score of at least 4.0 at baseline
- If currently prescribed pain medication (other than topicals or NSAIDS), a stable dose in the last two months
- If currently prescribed psychiatric medicine, a stable dose in the last two months
- Established history of VA primary care utilization (i.e., at least one primary care visit in the past year)
Exclusion Criteria
- Current or prior (past 12 months) engagement in psychotherapy or behavioral intervention provided by behavioral medicine services or specialty mental health for chronic pain.
- Medication management through psychiatric services or an on-going course of mental health services for issues other than chronic pain are not excluded.
- Endorsement of imminent suicide risk
- Current significant substance use problems (i.e., alcohol, opioids, benzodiazepines, or other drugs)
- Unstable psychiatric status (e.g., active psychosis, current mania)
- Diagnosed with major or minor neurocognitive disorder
- Unwilling to have treatment sessions audio recorded
- Pending disability claim
- Recent or planned surgical/interventional procedure for pain
Data sourced from ClinicalTrials.gov (NCT04724694). 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.