Integrated Telehealth Intervention To Reduce Chronic Pain And Unhealthy Drinking Among People Living With HIV (PLWH)

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Able to confirm HIV diagnosis, via visual evidence of antiretroviral (ART) medication bottle or medical record presented to study staff over Zoom.

• Engaged in unhealthy drinking, defined as:

• \>7 drinks for women / \> 14 drinks for men per week.

• OR ≥ 3 drinks for women / ≥4 drinks for men on one occasion in the past month.

• Experiencing moderate or greater chronic pain (4 or greater on the numerical pain rating scale) for at least 3 months.

• Own a smart phone.

• Lives in the USA.

• Has a US mailing address.

Locations
United States
Massachusetts
Charles River Campus, Boston University, Psychology Department- remote study
RECRUITING
Boston
Contact Information
Primary
Tibor P Palfai, PhD
palfai@bu.edu
(617) 353-9345
Backup
Kara Magane, MS
maganek@bu.edu
(617) 358-1369
Time Frame
Start Date: 2023-03-03
Estimated Completion Date: 2026-05
Participants
Target number of participants: 385
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Leads: Boston University

This content was sourced from clinicaltrials.gov