Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functioning Among Veterans

NCT04724694 | Completed Results

• 2 other identifiers: D3485-RRX003485-01A1
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is very common among primary care Veterans and can seriously impact overall patient functioning and well-being. Currently, behavioral treatments for pain management are not often provided in primary care because they are designed to be delivered in specialty care settings, such as chronic pain clinics. To address this gap in care, the proposed study will test if Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is an effective treatment. Therefore, the first objective of the proposed study is to conduct a randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to assess treatment effectiveness by examining changes in pain-related physical activity interference, psychological distress, pain intensity, and other related outcomes. 178 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), mid-treatment, post-treatment, and at 6-month follow-up. The second objective of this study is examine the mechanisms by which Brief CBT-CP leads to improvement in patient outcomes. Statistical analysis will reveal if changes pain self-efficacy (i.e., perceived ability to manage pain or engage in usual activities despite being in pain) and catastrophizing (i.e., unhelpful, negative though patterns about pain and pain management) lead to improvements in patient functioning. The third objective of this study will be to explore perceptions of Brief CBT-CP among patients who experience significant improvement in outcomes compared to those who did not experience improvement. Participants will include up to 40 patients who were treated with Brief CBT-CP. Participants will be interviewed about key components of the treatment and their perception of effectiveness. Interview data will be compared to the results of statistical analysis to help understand the mechanisms by which Brief CBT-CP is effective or identify areas for improvement. Results of this study will provide information needed to determine if Brief CBT-CP should be widely disseminated across VA primary care clinics.

Conditions

Pain; Musculoskeletal Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory -- Interference Subscale (BPI-I) to Assess 12 Week Follow-up

  This measure is a validated 7-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning. Average scores range from 0 to 10, with higher scores indicating higher pain-related interference.

  12-weeks

Secondary Outcomes (7)

• Brief Pain Inventory -- Pain Intensity Subscale (BPI-P) to Assess 12 Week Follow-up

  12-weeks

• Patient Health Questionnaire -- 9 (PHQ-9) to Assess 12 Week Follow-up

  12-weeks

• World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Physical Health at 12 Week Follow up

  12-weeks

• World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Psychological Quality of Life at 12 Week Follow up

  12-weeks

• World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Social Relationships at 12 Week Follow up

  12-weeks

Study Arms (2)

Brief CBT for Chronic Pain and treatment as usual

EXPERIMENTAL

Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. 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.

Behavioral: Brief CBT for Chronic Pain; Other: Treatment as usual

Treatment as usual only

OTHER

Participants assigned to treatment as usual 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.

Other: Treatment as usual

Interventions

Brief CBT for Chronic Pain BEHAVIORAL

Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. 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.

Also known as: Brief CBT-CP

Brief CBT for Chronic Pain and treatment as usual

Treatment as usual 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.

Also known as: Primary care treatment as usual

Brief CBT for Chronic Pain and treatment as usual; Treatment as usual only

Eligibility Criteria

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

You may qualify if:

• Veterans age \>=18 and \<=79 years
• Conversant in English
• A diagnosis of musculoskeletal pain of \>three months
• PEG score of \>= 4 on pain intensity item and both interference items at screening
• BPI interference and pain intensity score of at least 4.0 at baseline
• If currently prescribed pain medication (other than topicals or NSAIDS), a stable dose in the last two months
• If currently prescribed psychiatric medicine, a stable dose in the last two months
• Established history of VA primary care utilization (i.e., at least one primary care visit in the past year)

You may not qualify if:

• Current or prior (past 12 months) engagement in psychotherapy or behavioral intervention provided by behavioral medicine services or specialty mental health for chronic pain.
• Medication management through psychiatric services or an on-going course of mental health services for issues other than chronic pain are not excluded.
• Endorsement of imminent suicide risk
• Current significant 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
• Pending disability claim
• Recent or planned surgical/interventional procedure for pain

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215-1129, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Pain; Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Gregory Beehler, PhD, MA
• 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, NY

  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: January 14, 2021
• First Posted: January 26, 2021
• Study Start: October 1, 2021
• Primary Completion: January 27, 2025
• Study Completion: January 27, 2025
• Last Updated: March 17, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-02

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 Data Use Agreement (DUA).

Locations

US (1)