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NCT04680000
Chronic Pain Management In Primary Care Using Behavioral Health Consultants
Conditions: Chronic Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 716
Sponsor: The University of Texas Health Science Center at San Antonio
Location: Uniformed Services University for the Health Sciences Bethesda Maryland
Summary
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.
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
Source: ClinicalTrials.gov (NCT04680000). StuddyBuddy aggregates publicly available trial information.