Chronic Pain Management In Primary Care Using Behavioral Health Consultants
Purpose
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.
Condition
- Chronic Pain
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Pragmatic trial randomizing to two conditions (standard BCBT-CP and BCBT-CP + Booster) in a 1:1 ratio at the level of the individual
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- Pragmatic trial using a behavioral intervention. Treatment condition cannot be masked to the provider, patient or booster contact personnel. Assessments are self-report.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
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Recruiting Locations
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center at San Antonio
Detailed Description
The proposed study is the first effort to test a manualized cognitive-behavioral therapy intervention for chronic pain delivered by behavioral health providers working in primary care clinics. If successful, findings from this study will inform Defense Health Agency (DHA) policy nationwide. The study teams' DHA collaborators write these policies and the PIs are active participants in the DHA MHS Stepped Care Pain Pathway workgroup. Data from this study will inform military, VA and civilian primary care services about the contribution of integrated behavioral health pain management to pain outcomes, healthcare utilization, and satisfaction with care. 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.