Chronic Pain Management In Primary Care Using Behavioral Health Consultants (NCT04680000)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this randomized pragmatic trial is to assess the effect of monthly booster contacts on long-term Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) pain outcomes compared to BCBT-CP without a booster in 716 Military Health Systems (MHS) beneficiaries referred to a Behavioral Health Consultant (BHC) for pain management using BCBT-CP. Patients will be randomly assigned to receive either standard BCBT-CP (working with a BHC in the medical home clinic) or standard BCBT-CP with adjunctive monthly booster contacts. Patient participants will be assessed 3-, 6-, 12- and 18-Months following their first appointment for BCBT-CP. Prospective data will be supplemented by a national data pull in collaboration with the Defense Health Agency and the Uniformed Services University Center for Rehabilitation Sciences Research. Pulled data will include a national deidentified dataset of electronic health record data for all individuals treated in the military health system who had access to a Behavioral Health Consultant for the treatment under study in this trial.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (5 items).
Location: Uniformed Services University for the Health Sciences — Bethesda, Maryland
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Scheduled for a planned pain-related surgery or pain intervention within 6 weeks of enrollment (because the intervention may obscure BCBT-CP outcomes).
- Inability or unwillingness of individual to give written informed consent.
- 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
- BHC trained to deliver care according to the Chronic Pain Clinical Pathway
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (5 Sites)
- Uniformed Services University for the Health Sciences — Bethesda, Maryland
- Fort Cavazos — Fort Hood, Texas
- University of Texas Health Science Center San Antonio — San Antonio, Texas
- Wilford Hall Ambulatory Surgical Center — San Antonio, Texas
- Brooke Army Medical Center — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.