Chronic Pain Management In Primary Care Using Behavioral Health Consultants

NCT04680000 | Active Not Recruiting DMC

• 1 other identifier: HSC20200520H
• Study Type: interventional
• Target: 716
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Chronic Pain

Keywords

Chronic Pain; CBT; Behavioral Health Consultant; Primary Care

Outcome Measures

Primary Outcomes (2)

• Defense and Veterans Pain Rating Scale (DVPRS)

  Change in score on a Five-item self-report assessment of pain and pain interference. Scoring on each item is from 0, no pain to 10, as bad as the pain could be, nothing else matters. Total possible minimum score is 0 and maximum 50, with 50 being the worst pain.

  Baseline to 18 months

• Behavioral Health Measure-20 (BHM-20)

  Change in score on a Twenty-item self-report mental health assessment. Scoring is from 0-4 on each item. Possible total scores range from 0 to 80, with lower scores indicating poorer behavioral health.

  Baseline to 18 months

Secondary Outcomes (6)

• Pain Intensity, Enjoyment and General Activity (PEG-3)

  Baseline to 18 months

• Modified Oswestry Disability Index (ODI)

  Baseline to 18 months

• Pain Catastrophizing Scale (PCS)

  Baseline to 18 months

• Chronic Pain Acceptance Questionnaire (CPAQ)

  Baseline to 18 months

• Insomnia Severity Index (ISI)

  Baseline to 18 months

Other Outcomes (7)

• Alcohol Use Disorders Identification Test (AUDIT-C)

  Baseline to 18 months

• Pain Collaboratory Questionnaires

  Baseline to 18 months

• UCLA 3-Item Loneliness Scale

  Baseline to 18 months

Study Arms (2)

Standard BCBT-CP

ACTIVE COMPARATOR

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).

Behavioral: Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP)

Standard BCBT-CP with Telephone Booster

EXPERIMENTAL

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).

Behavioral: Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP); Other: BCBT-CP Booster

Interventions

Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) BEHAVIORAL

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; Standard BCBT-CP with Telephone Booster

BCBT-CP Booster OTHER

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.

Standard BCBT-CP with Telephone Booster

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• BHC trained to deliver care according to the Chronic Pain Clinical Pathway
• Clinic providers/staff caring for patient participants enrolled in this study

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: collaborator
• Defense Health Agency: collaborator
• The University of Texas Health Science Center at San Antonio: lead
• Massachusetts General Hospital: collaborator
• 59th Medical Wing: collaborator
• Brooke Army Medical Center: collaborator
• C.R.Darnall Army Medical Center: collaborator

Study Sites (5)

Uniformed Services University for the Health Sciences

Bethesda, Maryland, 20814, United States

Location

Fort Cavazos

Fort Hood, Texas, 76544, United States

Location

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

Wilford Hall Ambulatory Surgical Center

San Antonio, Texas, 78236-9908, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78257, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Donald J McGeary, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Pragmatic trial using a behavioral intervention. Treatment condition cannot be masked to the provider, patient or booster contact personnel. Assessments are self-report.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic trial randomizing to two conditions (standard BCBT-CP and BCBT-CP + Booster) in a 1:1 ratio at the level of the individual

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: August 17, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: At study completion and in peer reviewed scientific journals after review and publication.
• Access Criteria: Access will be granted to those with explicit permission from the PIs and in accordance with regulatory protocols.

Locations

US (5)