Brief Cognitive Behavioral Therapy for Chronic Pain
Condition: Chronic Pain; Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Chronic Pain
Study type: Interventional

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.
    

Detailed description: 
      We will recruit 30 Veterans from the primary care clinics located at the Buffalo Veterans
      Affairs medical center in Buffalo, New York. Thirty eligible participants will be randomized
      in a 1:1 ratio into either (1) Brief Cognitive Behavioral Therapy for Chronic Pain (Brief
      CBT-CP) plus treatment as usual (TAU) or (2) TAU only. We will engage in recruitment during
      the second quarter of Year 1 through the end of the first quarter of Year 2. We aim to
      recruit and enroll 7-8 participants per quarter during that time frame. Post-treatment
      follow-up will be conducted at eight weeks and at 12 weeks. Two recruitment methods will be
      used. Veterans with chronic musculoskeletal pain who self-report functional impairment will
      be referred by their primary care team, in response to a recruitment flyer posted in primary
      care, or by contacting the principal investigator or study staff directly after hearing of
      the study by word of mouth or other sources. This approach will be supplemented by a
      case-finding procedure in which study staff review electronic medical record data to identify
      potential patients, who will be subsequently contacted by letter and screened by telephone.
      Following telephone screening, potentially eligible participants will complete a baseline
      assessment to assess pain and related characteristics as well as remaining exclusion
      criteria. Those passing baseline measures will be randomized to (1) Brief CBT-CP plus TAU or
      (2) TAU only. Assignment to Brief CBT-CP will be stratified based on degree of pain
      interference.

      Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course
      of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix.
      Session one focuses on foundational pain education and the development of treatment goals.
      Session two emphasizes balanced engagement in physical activity and pleasurable events.
      Session three emphasizes skills training for easily implemented relaxation techniques.
      Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively
      impact pain. Session six focuses on relapse prevention and independent implementation of
      CBT-CP skills following treatment. Brief CBT-CP will be delivered by a masters-level
      interventionist either at the medical center or by telephone depending on the preference of
      the participant.

      Participants assigned to TAU only will receive standard medical care from their primary care
      provider including pain medications, brief advice (e.g., use of relative rest, application of
      heat or ice, other self-care strategies), or referral to pain-related adjunctive
      interventions (e.g., physical therapy), as indicated. Participants in TAU only will not
      receive behavioral intervention from the primary care clinic behavioral health provider.

      We will conduct brief interviews with up to 24 purposefully selected participants (i.e., 12
      providers and 12 patients). The provider group will include 6 primary care providers and 6
      behavioral health providers I providers who staff Veterans Affairs primary care clinics.
      Interview items are based on implementation constructs relevant for early stage intervention
      development: acceptability (or agreeableness and satisfaction with treatment components),
      appropriateness (or perceived fit/compatibility of the intervention), and feasibility (or
      whether the intervention is suitable for use.) Up to 12 patients who were randomized to Brief
      CBT-CP will be asked to complete a 30-minute interviews (i.e., telephone or face-to-face,
      depending on participant preference) following their 12-week assessment (as described in the
      consent procedures prior to the trial). We will include participants who completed all study
      procedures but will also attempt to include those who discontinued Brief CBT-CP.
    

Intervention name(s): Treatment as usual (TAU); Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)
Intervention type(s): Other; Behavioral
Intervention description(s): Participants assigned to TAU will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.; Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arm parallel design: 1) primary care treatment as usual, or 2) primary care treatment as usual and Brief Cognitive Behavioral Therapy for Chronic Pain
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: primary care; chronic pain; musculoskeletal pain; cognitive behavioral therapy; integrated primary care