Managing chronic pain in primary care with behavioral health support

Targeting Chronic Pain in Primary Care Settings Using Behavioral Health Consultants, A Randomized Pragmatic Trial

This study is testing if adding extra support sessions to a pain management therapy helps military members with chronic pain feel better and manage their pain more effectively.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 716 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (Academic / other)
• Locations: 5 sites (Bethesda, Maryland and 4 other locations)
• Trial ID: NCT04680000 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) with and without monthly booster contacts for military health beneficiaries experiencing chronic pain. Participants will be randomly assigned to receive either standard BCBT-CP or BCBT-CP with additional booster sessions to enhance long-term pain management outcomes. The study aims to gather data on pain outcomes, healthcare utilization, and patient satisfaction, with assessments conducted at multiple time points over 18 months. Focus groups will also be conducted to gather insights from patients and clinic staff regarding the intervention's usability and effectiveness.

Who should consider this trial

Good fit: Ideal candidates include active duty service members, veterans, and their family members aged 18 and older who are experiencing chronic pain.

Not a fit: Patients scheduled for pain-related surgery or those with other health issues that take priority may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve pain management and quality of life for patients with chronic pain.

How similar studies have performed: Preliminary studies of similar cognitive-behavioral therapy approaches have shown promise, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. DoD/MHS beneficiary (including active duty service members, veterans, and family members) age 18 and older.
2. Presenting with a chronic pain complaint (pain occurring more days than not over the past three months that is ongoing at the time of baseline evaluation).
3. Referred for BCBT-CP with a BHC by a Primary Care provider.
4. Speaks and reads/understands English well enough to fully participate in the intervention and to reliably complete assessment measures.

Exclusion Criteria:

1. Scheduled for a planned pain-related surgery or pain intervention within 6 weeks of enrollment (because the intervention may obscure BCBT-CP outcomes).
2. Inability or unwillingness of individual to give written informed consent.
3. Experiencing another health problem of higher priority for care or that prohibits ability to attend BCBT-CP or research appointments.

Some research activities (i.e., Focus Groups) will include Clinic Providers and Staff:

Inclusion Criteria for Clinic Provider/Staff Participants

1. BHC trained to deliver care according to the Chronic Pain Clinical Pathway
2. Clinic providers/staff caring for patient participants enrolled in this study

Exclusion Criteria for Clinic Provider/Staff Participants: none

Where this trial is running

Bethesda, Maryland and 4 other locations

• Uniformed Services University for the Health Sciences — Bethesda, Maryland, United States (Recruiting)
• Fort Cavazos — Fort Hood, Texas, United States (Active_not_recruiting)
• University of Texas Health Science Center San Antonio — San Antonio, Texas, United States (Recruiting)
• Wilford Hall Ambulatory Surgical Center — San Antonio, Texas, United States (Recruiting)
• Brooke Army Medical Center — San Antonio, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Donald J McGeary, PhD — UT Health San Antonio
• Study coordinator: Donald McGeary, PhD

Conditions Chronic Pain; CBT; Behavioral Health Consultant; Primary Care