N/A
N=30
Brief Cognitive Behavioral Therapy for Chronic Pain
Chronic Pain · Musculoskeletal Pain
Bottom Line
View on ClinicalTrials.gov: NCT03490981 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Mar 2021
Primary outcome: Primary: West Haven-Yale Multidimensional Pain Inventory - Interference (WHYMPI-I) to Assess Change at Follow up — 3.43; 3.10 units on a scale — p=.486
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Treatment as usual (TAU) (Other); Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY West Haven-Yale Multidimensional Pain Inventory - Interference (WHYMPI-I) to Assess Change at Follow up |
3.43; 3.10 | .486 |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) to Assess Change at Follow up |
7.35; 6.23 | .342 |
| SECONDARY Generalized Anxiety Disorder-7 (GAD-7) to Assess Change at Follow up |
4.97; 5.57 | .646 |
| SECONDARY Pain Numeric Rating Scale (NRS) to Assess Change at Follow up |
5.37; 4.24 | .205 |
| SECONDARY Pain Self-Efficacy Questionnaire (PSEQ) to Assess Change at Follow up |
37.50; 39.54 | .492 |
| SECONDARY Pain Catastrophizing Scale (PCS) to Assess Change at Follow up |
23.1; 18.8 | .272 |
| SECONDARY World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Change at Follow up |
92.1; 92.9 | .870 |
| SECONDARY Ability to Participate in Social Roles and Activities - Short Form (APSRA) to Assess Change at Follow up |
27.76; 26.80 | .570 |
Summary
Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is designed specifically for use in integrated care settings. The first objective of the proposed study is to conduct a pilot randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to assess feasibility (i.e., recruitment and retention of participants, appropriateness of measures, and assessment of fidelity of service delivery). This trial will also preliminarily assess treatment effectiveness by examining changes in pain-related physical interference, psychological distress, pain intensity, and other related outcomes. Thirty 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), post-treatment, and at 12-week follow-up. The second objective of this study will be to explore patient and provider perceptions of Brief CBT-CP to identify potential modifications that will improve its quality and overall feasibility of delivery in future work. Participants will include up to 12 staff members as well as up to 12 patients who were randomized to Brief CBT-CP. Participants will be interviewed by telephone about key components of the treatment. Participants will comment on protocol and procedures in terms of acceptability (the perception that a treatment is agreeable or that its specific components are satisfactory), appropriateness (the perceived fit or compatibility of the intervention for a given provider or consumer), and feasibility (the extent to which a new treatment can be successfully carried out or is suitable for everyday use). This intervention has clear implications for translation to clinical practice and for improving pain care quality by providing an evidence-based protocol. The potential direct benefit to Veterans includes offering a safe, accessible, non-pharmacological treatment for chronic pain early in the trajectory of care.
Eligibility Criteria
Inclusion Criteria
- A diagnosis of musculoskeletal pain of three months
- Pain-related functional impairment
- If currently prescribed pain or psychiatric medicine, a stable dose in the last three months (other than over-the-counter medicines)
- Conversant in English
- Established history of Veterans Affairs primary care utilization (i.e., at least one primary care visit in the past year)
Exclusion Criteria
- Current engagement in psychotherapy or behavioral intervention provided by behavioral medicine services, specialty mental health, or Primary Care Mental Health Integration services for any indication. Note that medication management through these services is not excluded.
- Receiving medical treatments (e.g., surgery, injections) known to impact pain-related outcomes
- Endorsement of imminent suicide risk
- Current 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
Data sourced from ClinicalTrials.gov (NCT03490981). 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.