Pragmatic RCT of SBIRT-PM
NCT04062214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1101
Last updated 2026-03-03
Summary
Veterans seeking compensation for musculoskeletal (MSD) conditions often develop chronic pain and are at high risk for substance misuse. The Investigators propose to test the effectiveness and cost-effectiveness of Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM), designed to reduce pain and reduce risky substance use, in part by helping Veterans get comprehensive pain treatment. The study will involve clinicians at a single site contacting Veterans throughout New England by phone to deliver SBIRT-PM counseling in a pragmatic, randomized, clinical trial.
Conditions
Interventions
- BEHAVIORAL
-
SBIRT-PM
SBIRT-PM involves an initial telephone-delivered session followed by up to three calls to Veterans in a 12-week period to support Veteran engagement in multi-modal non-pharmacological pain care and to motivate those who misuse substances to change this problematic behavior. SBIRT-PM also includes coordination between the SBIRT-PM clinicians and the PACT nurse case manager after the initial session to support these patient outcomes.
Sponsors & Collaborators
-
National Center for Complementary and Integrative Health (NCCIH)
collaborator NIH -
National Institute on Drug Abuse (NIDA)
collaborator NIH -
US Department of Veterans Affairs
collaborator FED -
Yale University
lead OTHER
Principal Investigators
-
Marc Rosen, MD · Yale University/ VA Connecticut Healthcare System
-
Steve Martino, PhD · Yale University/ VA Connecticut Healthcare System
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-23
- Primary Completion
- 2024-04-11
- Completion
- 2024-04-11
Countries
- United States
Study Locations
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