Purpose

This pilot study seeks to provide effect size estimates and test feasibility of a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing.

Conditions

Eligibility

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

Inclusion Criteria

  • engaged in HIV care, heavy drinking defined as more than 7/14 drinks per week for women/men or by a single episode of 4/5 (women/men), chronic (at least 3 months duration) moderate or greater (4 or more on the severity scale of the BPI, and non-cancer related pain

Exclusion Criteria

  • psychoactive medication for pain or alcohol use for fewer than 2 months - history of bipolar disorder or schizophrenia - current expressed suicidal intent - prior history of alcohol withdrawal related seizures or delirium tremens - current behavioral treatment for pain or alcohol use - any scheduled surgery within the next 6 months or acute life threatening illness that requires treatment

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Compare Intervention to Control Condition in a Between Subjects Design
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Three and six month assessments will be conducted by RA who is masked to intervention condition

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention
Videoconferencing Intervention for Heavy Drinking and Chronic Pain
  • Behavioral: Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)
    Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity
    Other names:
    • Intervention
Active Comparator
Control
Treatment as Usual
  • Behavioral: Treatment as Usual
    Psychoeducation and Information about Treatment Resources
    Other names:
    • Control

Recruiting Locations

Boston University Department of Psychological and Brain Sciences
Boston, Massachusetts 02215
Contact:
Tibor P. Palfai, PhD
617-353-9345
palfai@bu.edu

General Clinical Research Unit, Boston University
Boston, Massachusetts 02215
Contact:
Ridiane Denis, MD
617-358-7558
ridianed@bu.edu

More Details

Status
Recruiting
Sponsor
Boston University Charles River Campus

Study Contact

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

Detailed Description

This pilot study is a between-groups design to compare a novel integrated behavioral video telehealth intervention for heavy drinking PLWH with chronic pain to a control condition. Forty-eight heavy drinking patients in HIV-care with moderate or greater pain will be recruited for the study. Following baseline assessment, participants will be randomly assigned to either intervention or control conditions. Participants will complete assessment measures of heavy drinking and pain interference/severity at 3 and 6 months post-baseline. Secondary alcohol outcomes will include alcohol-related consequences

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.