Chronic Pain Management In Primary Care Using Behavioral Health Consultants
NCT ID: NCT04680000
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
716 participants
INTERVENTIONAL
2021-08-17
2027-01-31
Brief Summary
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Detailed Description
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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.
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). CBT-CP has been disseminated throughout the VA healthcare system as a manualized, non-pharmacological intervention for chronic pain (Stewart et al., 2015). Preliminary studies of CBT-CP found that most patients completed all ten CBT-CP modules (Stewart et al., 2015) and better outcomes were associated with home-based skills practice (Edmond et al., 2017). One study of CBT-CP in the VA found that over 50% of patients who were offered the treatment declined and individuals with a history of opioid use were under-engaged for this efficacious treatment (Higgins et al., 2018). Thus, the DHA abbreviated CBT-CP to only seven modules for implementation in primary care, where most patients with pain are seen (including those with active and past opioid use). The seven modules are:
(A) Assessment, engagement and goal setting, (B) Education on chronic pain and relaxation training, (C) Discussion of the importance of activity engagement and pacing, (D) Progressive muscle relaxation and guided imagery, (E) Identifying thoughts that negatively impact pain, (F) Modifying thoughts that negatively impact pain, and (G) Developing an action plan.
Patients are encouraged to complete a minimum of four modules with their provider (i. e., A, B, G, and at least one additional module). BCBT-CP was developed in collaboration with the developers of CBT-CP to establish a brief version of protocol suitable for delivery by BHCs working in MHS Primary Care clinics.
Each module appointment lasts approximately 30 minutes and includes the following treatment components:
Introduction to the module and confirmation of session agenda Check on mood and completion of patient measures (DVPRS, PEG-3, BHM-20, PHQ-9, PCL-5) Review of material from previous modules, including home practice Introduction of the new material and answer questions Module wrap-up BHCs are trained by the DHA on how to effectively introduce and "sell" BCBT-CP to patients and have access to supplemental and appended materials to address comorbidities.
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 BCBT-CP appointment, refresh BCBT-CP module content, and remind about next BCBT-CP appointment.
Booster contacts will be scheduled 1-week following each BCBT-CP module. Booster contacts will occur at least one week after a BCBT-CP module but no more than 2 weeks after a BCBT-CP module. Following completion of care on the BCBT-CP pathway, booster contacts will continue monthly through month 12 of study participation. Depending on how often the BHC can meet with the patient-participant to receive module care, participants could have a varying number of booster calls, but based on the investigators' pilot study when patients could only meet with their BHC on average once a month, the investigators believe that most patients will receive 12 booster contacts. The booster contacts may occur via telephone or video conferencing and will be audio-recording using and independent device (separate from the conferencing platform, e.g. Zoom).
All Booster providers (research staff) will receive a two-hour training on conducting Booster Contacts from the study PIs including description of how to complete the BCBT-CP Booster Protocol Form.
National data pull for will include healthcare utilization data for all individuals with identified musculoskeletal pain treated in the Military Health System in a clinic with an identified BHC trained to provide BCBT-CP between Jan 2018 and Dec 2024. The data pull will be coordinated in collaboration with the Defense Health Agency and the Uniformed Services University Center for Rehabilitation Sciences Research. The group will complete a DRT request to identify data items to collect, establish a data management and transfer plan (including a plan for deidentifying data) and an analysis plan (analysis to complete with collaborators at Harvard Medical School).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP)
BCBT-CP is the standard of care for behavioral management of acute and chronic pain in the Defense Health Agency Stepped Care Pain Pathway. BCBT-CP is a 7-module, CBT-based intervention for the treatment of acute and chronic pain in the primary care setting. The BCBT-CP manual was developed in a collaboration between the Defense Health Agency and the Department of Veterans Affairs as an intervention tailored for use by Behavioral Health Consultants embedded in Military Health System primary care clinics and Patient Centered Medical Homes. Details on BCBT-CP content can be found in the treatment arm description section of this listing.
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).
Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP)
BCBT-CP is the standard of care for behavioral management of acute and chronic pain in the Defense Health Agency Stepped Care Pain Pathway. BCBT-CP is a 7-module, CBT-based intervention for the treatment of acute and chronic pain in the primary care setting. The BCBT-CP manual was developed in a collaboration between the Defense Health Agency and the Department of Veterans Affairs as an intervention tailored for use by Behavioral Health Consultants embedded in Military Health System primary care clinics and Patient Centered Medical Homes. Details on BCBT-CP content can be found in the treatment arm description section of this listing.
BCBT-CP Booster
The BCBT-CP Booster is a telephone or videoteleconference-based booster contact designed to extend the benefits of the standard of care BCBT-CP intervention. BCBT-CP Booster contacts are not clinical interventions (i.e., no new clinical content is provided), but are intended to help motivate patients to use BCBT-CP module content, problem-solve BCBT-CP skills practice and offer reminders for future appointments. BCBT-CP Booster content was developed using feedback from focus groups with patients who completed standard BCBT-CP treatment in a military primary care clinic. Details on BCBT-CP Booster contacts can be found in the treatment arm description section of this listing.
Interventions
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Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP)
BCBT-CP is the standard of care for behavioral management of acute and chronic pain in the Defense Health Agency Stepped Care Pain Pathway. BCBT-CP is a 7-module, CBT-based intervention for the treatment of acute and chronic pain in the primary care setting. The BCBT-CP manual was developed in a collaboration between the Defense Health Agency and the Department of Veterans Affairs as an intervention tailored for use by Behavioral Health Consultants embedded in Military Health System primary care clinics and Patient Centered Medical Homes. Details on BCBT-CP content can be found in the treatment arm description section of this listing.
BCBT-CP Booster
The BCBT-CP Booster is a telephone or videoteleconference-based booster contact designed to extend the benefits of the standard of care BCBT-CP intervention. BCBT-CP Booster contacts are not clinical interventions (i.e., no new clinical content is provided), but are intended to help motivate patients to use BCBT-CP module content, problem-solve BCBT-CP skills practice and offer reminders for future appointments. BCBT-CP Booster content was developed using feedback from focus groups with patients who completed standard BCBT-CP treatment in a military primary care clinic. Details on BCBT-CP Booster contacts can be found in the treatment arm description section of this listing.
Eligibility Criteria
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Inclusion Criteria
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.
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
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:
18 Years
ALL
No
Sponsors
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Uniformed Services University of the Health Sciences
FED
Massachusetts General Hospital
OTHER
Defense Health Agency
FED
59th Medical Wing
FED
Brooke Army Medical Center
FED
C.R.Darnall Army Medical Center
FED
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Donald J McGeary, PhD
Role: PRINCIPAL_INVESTIGATOR
UT Health San Antonio
Locations
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Uniformed Services University for the Health Sciences
Bethesda, Maryland, United States
Fort Cavazos
Fort Hood, Texas, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
Wilford Hall Ambulatory Surgical Center
San Antonio, Texas, United States
Brooke Army Medical Center
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC20200520H
Identifier Type: -
Identifier Source: org_study_id
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