Telehealth for Pain and Unhealthy Drinking Among PLWH
NCT05503173 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 385
Last updated 2025-06-17
Summary
This randomized controlled trial is a between-groups design to compare the Motivational and Cognitive Behavioral Management for Alcohol and Pain (MCBMAP) Intervention to a Brief Advice and Information Control condition.
Two-hundred and fifty participants who have HIV with moderate or greater chronic pain will be randomized for the trial. Recruitment will take place through digital media. A unique feature of this intervention trial is that most of the procedures will be conducted remotely which will minimize barriers of transportation and time for participants. Consent and baseline assessment will be completed remotely. Following baseline assessment, participants will complete two weeks of ecological momentary assessment (EMA) to assess alcohol use, chronic pain, physical function and mechanisms of behavior change for alcohol and pain management. Following the two-week phase, participants will be randomly assigned to either the intervention or control condition and meet the interventionist through videoconferencing. Participants will complete outcome assessment measures at 3- and 6-months post-baseline. Following the 3-month outcome assessment, participants will complete another two weeks of EMA.
Conditions
- HIV
- Chronic Pain
- Unhealthy Alcohol Use
Interventions
- BEHAVIORAL
-
MCBMAP
MCBMAP integrates motivational interviewing (MI) and cognitive-behavioral skill training interventions for unhealthy drinking with cognitive-behavioral and self- management approaches for chronic pain. The intervention is delivered through internet-based videoconferencing and supplemented with web-based content to support the intervention. The initial treatment session provides a rationale for addressing alcohol and pain together in the context of HIV management, and initiates MI related to alcohol use. Participants receive 6 additional treatment sessions over the subsequent weeks.
- OTHER
-
Brief Advice and Information
Through videoconferencing an interventionist will provide participants psychoeducation about the effects of alcohol and pain on HIV symptoms, advice/recommendations to reduce alcohol use, and a list of local treatment resources for alcohol and chronic pain.
Sponsors & Collaborators
-
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
collaborator NIH -
Boston University
lead OTHER
Principal Investigators
-
Tibor P Palfai, PhD · Boston Medical Center, Psychiatry; BU Psychological & Brain Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-03
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
Countries
- United States
Study Locations
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