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Clinical Trials/NCT04441593
NCT04441593
Completed
N/A

Internet-based Videoconferencing to Address Alcohol Use and Pain Among People With HIV

Boston University Charles River Campus2 sites in 1 country49 target enrollmentDecember 23, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alcohol Drinking and Chronic Pain Intervention
Sponsor
Boston University Charles River Campus
Enrollment
49
Locations
2
Primary Endpoint
Brief Pain Inventory - Pain Severity
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 23, 2020
End Date
February 2, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Boston University Charles River Campus
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Brief Pain Inventory - Pain Severity

Time Frame: Past 7 days

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

Brief Pain Inventory - Pain Interference

Time Frame: Past 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 Episodes

Time Frame: Past 30 days

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

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

Time Frame: Past 30 days

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

Secondary Outcomes

  • Short Inventory of Alcohol Problems-Revised(3 months)
  • Goal Systems Assessment Battery-Pain(Past 30 days)
  • Goal Systems Assessment Battery-Alcohol(Past 30 days)

Study Sites (2)

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