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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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. Additionally, patient participants and clinic providers and staff will be offered the opportunity to participate in separate post-treatment Focus Groups using a semi-structured interview format designed to assess the usability, ease of use, perceived effectiveness, helpfulness, and barriers to the pain management intervention. 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• DoD/MHS beneficiary (including active duty service members, veterans, and family members) age 18 and older.

• 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).

• Referred for BCBT-CP with a BHC by a Primary Care provider.

• Speaks and reads/understands English well enough to fully participate in the intervention and to reliably complete assessment measures.

• BHC trained to deliver care according to the Chronic Pain Clinical Pathway

• Clinic providers/staff caring for patient participants enrolled in this study

Locations
United States
Maryland
Uniformed Services University for the Health Sciences
RECRUITING
Bethesda
Texas
Fort Cavazos
ACTIVE_NOT_RECRUITING
Fort Hood
Brooke Army Medical Center
RECRUITING
San Antonio
University of Texas Health Science Center San Antonio
RECRUITING
San Antonio
Wilford Hall Ambulatory Surgical Center
RECRUITING
San Antonio
Contact Information
Primary
Donald McGeary, PhD
mcgeary@uthscsa.edu
210-567-5454
Time Frame
Start Date: 2021-08-17
Estimated Completion Date: 2027-01
Participants
Target number of participants: 716
Treatments
Active_comparator: Standard BCBT-CP
Brief Cognitive Behavior Therapy for Chronic Pain (BCBT-CP) is a seven-module intervention for chronic pain based on the efficacious specialty-care, ten-session version of this treatment called Cognitive Behavioral Therapy for Chronic Pain (CBT-CP).
Experimental: Standard BCBT-CP with Telephone Booster
Participants will receive standard BCBT-CP as described in the Standard BCBT-CP arm. They will also receive telephone or video teleconference booster contacts as follows:~BCBT-CP Booster Contacts are intended to refresh BCBT-CP content without introducing new skills. To accomplish this, Booster Contacts are manualized (see appended Booster Protocol form) to cover assessment of pain since last contact, review of most recent BCBT-CP module(s) and reminder about the next BCBT-CP appointment (if one is scheduled).
Related Therapeutic Areas
Sponsors
Collaborators: Brooke Army Medical Center, 59th Medical Wing, Defense Health Agency, C.R.Darnall Army Medical Center, Massachusetts General Hospital, Uniformed Services University of the Health Sciences
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov