RCT of Brief Cognitive Behavioral Therapy for Chronic Pain

Va Western New York Healthcare System, Buffalo NY

Investigators

Linked publications, trials & patents

Abstract

The VHA's Stepped Care Model for Pain Management calls for biopsychosocial management of chronic pain at all levels, including primary care where the majority of patients with chronic pain are treated. Behavioral health providers embedded in primary care as part of the Primary Care-Mental Health Integration (PC-MHI) program are well-positioned to support Veterans with chronic pain by delivering brief behavioral and psychological therapies. However, VHA's gold standard behavioral treatment, cognitive behavioral therapy (CBT) for chronic pain, cannot feasibly be delivered by integrated care providers. Despite its effectiveness in treating pain, full-length CBT for chronic pain was developed as part of VA's evidence-based psychotherapy program for use in specialized care settings (e.g., multidisciplinary pain clinics) that can accommodate up to twelve 50-minute therapy sessions. In contrast, PC-MHI services are designed to be a brief (30-minute appointments), time-limited (?6 sessions) treatment that aligns with the PACT approach. To address the critical gap in treatment options for Veterans in primary care, we have developed an abbreviated version of CBT, Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP), specifically for use in PC-MHI. 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. This single-site study will be a two-arm, parallel randomized controlled trial. Thirty eligible participants will be randomized in a 1:1 ratio 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 weekly 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 primary care stakeholders' (patients and providers) 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 the protocol and study 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 been designed specifically for PC-MHI providers and therefore 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 VA care.