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Internet-based Video-conferencing to Address Alcohol Use and Pain: a Pilot Trial

Not Applicable
Completed
Conditions
Alcohol Drinking and Chronic Pain Intervention
Control Condition
Interventions
Behavioral: Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)
Behavioral: Treatment as Usual
Registration Number
NCT04441593
Lead Sponsor
Boston University Charles River Campus
Brief Summary

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.

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
49
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionMotivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)Videoconferencing Intervention for Heavy Drinking and Chronic Pain
ControlTreatment as UsualTreatment as Usual
Primary Outcome Measures
NameTimeMethod
Brief Pain Inventory - Pain SeverityPast 7 days

BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10

Brief Pain Inventory - Pain InterferencePast 7-Days

BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10. Pain Interference is measured as the mean of 7-items each rated on an 11-point scale

Alcohol Time Line Follow-Back (30)- Heavy Drinking EpisodesPast 30 days

Number of heavy drinking episodes NIAAA criteria (5+drinks men/ 4+ drinks women)

Alcohol Time Line Follow-Back (30) - Average Drinks per WeekPast 30 days

Average number of standard alcohol-containing drinks in the past 30 days

Secondary Outcome Measures
NameTimeMethod
Short Inventory of Alcohol Problems-Revised3 months

17-item measure with 4-point Likert scale items ranging from "0" never to "3" daily/almost daily. Scale range 0-51

Goal Systems Assessment Battery-PainPast 30 days

Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes

Goal Systems Assessment Battery-AlcoholPast 30 days

Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes

Trial Locations

Locations (2)

Boston University Department of Psychological and Brain Sciences

🇺🇸

Boston, Massachusetts, United States

General Clinical Research Unit, Boston University

🇺🇸

Boston, Massachusetts, United States

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