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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • History of bipolar, schizoaffective disorder or schizophrenia per self report. - Unstable dose of psychoactive medication for pain or alcohol/substance use [i.e., if on medication, participant has not been on same dose for least 2 months] - History of withdrawal-related seizures or delirium tremens - Current non-pharmacological treatment for alcohol use disorder or chronic pain - Acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months. - Current cancer-related pain - Unable to provide one or more individuals for follow-up contact - Individual who is unwilling to provide their sex at birth - Limited or non-readers

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
Active Comparator
Brief Advice and Information 		Participants randomized to this arm will be provided treatment as usual for their conditions.
  • 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.
    Other names:
    • Treatment as usual

Recruiting Locations

Charles River Campus, Boston University, Psychology Department- remote study
Boston, Massachusetts 02115
Contact:
Kara Magane, MS
617-358-1369
maganek@bu.edu

More Details

Status
Recruiting
Sponsor
Boston University

Study Contact

Tibor P Palfai, PhD
(617) 353-9345
palfai@bu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.