Brief Cognitive Behavioral Therapy for Chronic Pain

NCT03490981 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-03-03

Study results available
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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.

Conditions

Interventions

OTHER

Treatment as usual (TAU)

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.

BEHAVIORAL

Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Gregory P. Beehler, PhD · VA Western New York Healthcare System, Buffalo, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-01-20
Completion
2020-05-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03490981 on ClinicalTrials.gov