Telehealth for Pain and Unhealthy Drinking Among PLWH

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University
Study ID
NCT05503173
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pain
  • HIV
  • Unhealthy Alcohol Use

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MCBMAP — BEHAVIORAL
    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.
  • Brief Advice and Information — OTHER
    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.

Study Details

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.

Key Dates

Start date
Mar 3, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
385 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Motivational and Cognitive-Behavioral Management for Alcohol and Pain Intervention (MCBMAP)
    Participants randomized to this arm will receive MCBMAP which utilizes a self-regulation framework to integrate evidence-based approaches for chronic pain and unhealthy drinking.
  • Active Comparator: Brief Advice and Information
    Participants randomized to this arm will be provided treatment as usual for their conditions.

Primary Outcome Measure

Number of alcoholic drinks consumed per week at 6 months [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Charles River Campus, Boston University, Psychology Department- remote studyBostonMassachusetts02115
Kara Magane, MS
[email protected]
617-358-1369

Find similar trials in Boston, MA

By condition
HIV
By specialty
Infectious disease
By research site
Charles River Campus, Boston University, Psychology Department- remote study· Boston, MA

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