Brief Cognitive Behavioral Therapy for Chronic Pain

NCT03490981 | Completed Results

• 2 other identifiers: D2741-P1I21RX002741-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Pain; Musculoskeletal Pain

Keywords

primary care; chronic pain; musculoskeletal pain; cognitive behavioral therapy; integrated primary care

Outcome Measures

Primary Outcomes (1)

• West Haven-Yale Multidimensional Pain Inventory - Interference (WHYMPI-I) to Assess Change at Follow up

  The WHYMPI-I is a validated 9-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning. Average scores range from 0 to 6, with higher scores indicating higher pain-related interference.

  12 weeks

Secondary Outcomes (7)

• Patient Health Questionnaire-9 (PHQ-9) to Assess Change at Follow up

  12 weeks

• Generalized Anxiety Disorder-7 (GAD-7) to Assess Change at Follow up

  12 weeks

• Pain Numeric Rating Scale (NRS) to Assess Change at Follow up

  12 weeks

• Pain Self-Efficacy Questionnaire (PSEQ) to Assess Change at Follow up

  12 weeks

• Pain Catastrophizing Scale (PCS) to Assess Change at Follow up

  12 weeks

Study Arms (2)

Treatment as usual (TAU) only

OTHER

Primary care treatment as usual

Other: Treatment as usual (TAU)

Treatment as usual (TAU) plus Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)

EXPERIMENTAL

Primary care treatment as usual and Brief CBT-CP

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

Interventions

Treatment as usual (TAU) OTHER

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.

Treatment as usual (TAU) only

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

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.

Treatment as usual (TAU) plus Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Western New York Healthcare System, Buffalo, New York

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Dr. Gregory P. Beehler, Associate Director of Research
• Organization: VA Center for Integrated Healthcare

gregory.beehler@va.gov

716-862-7934

Study Officials

• Gregory P. Beehler, PhD

  VA Western New York Healthcare System, Buffalo, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcomes assessor will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 6, 2018
• Study Start: October 1, 2018
• Primary Completion: January 20, 2020
• Study Completion: May 1, 2020
• Last Updated: March 3, 2021
• Results First Posted: March 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be made available for up to three years starting six months after final publication.
• Access Criteria: Data will be shared upon completion of a written request and within 90 days of a completed DUA.

Locations

US (1)