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Clinical Trials/NCT03982433
NCT03982433
Completed
Not Applicable

Internet-based Video-conferencing to Address Alcohol Use and Pain Among Heavy Drinkers in HIV-care

Boston University Charles River Campus1 site in 1 country8 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Boston University Charles River Campus
Enrollment
8
Locations
1
Primary Endpoint
Brief Pain Inventory Pain Severity
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This research seeks to develop a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing. This first open trial pilot study seeks to recruit patients in the clinic through posted flyers, cards and physician referral.

Detailed Description

This study seeks to develop an integrated, behavioral video telehealth approach to address pain and heavy alcohol use among patients living with HIV and determine its feasibility and acceptability. Through an open pilot trial, this phase of this project will deliver an integrated alcohol-pain behavioral intervention to people living with HIV/AIDS (PLWHA) through videoconferencing. Intervention evaluation outcomes for this initial phase will include reduction of standard number of drinks per week, reduction in heavy drinking days, reduction of chronic pain severity and interference, ratings of patient satisfaction with treatment, and rate of treatment adherence.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
June 27, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Boston University Charles River Campus
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • engaged in HIV care, heavy drinking by more than 7/14 drinks per week (women/men) or by 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 Brief Pain Inventory (BPI) non-cancer related pain.

Exclusion Criteria

  • psychoactive medication for pain or alcohol use for few than 2 months
  • history of bipolar disorder, schizophrenia, other psychotic disorder
  • current suicidal intent
  • prior history of alcohol withdrawal related seizures or delirium tremens
  • current behavioral treatment for pain or alcohol use
  • any scheduled surgery within 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 consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where "0" is best and "10" is worst. Pain interference is measures as the mean of 7-items, each also rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10

Alcohol Time Line Follow Back...Average Drinks Per Week

Time Frame: past 30 days

average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28)

Client Satisfaction Questionnaire-8 [Modified]

Time Frame: past 30 days

Evaluative ratings of the intervention received. Eight Likert-scale items regarding different components of treatment satisfaction are rated from 1-4. Some items are reversed scored and then they are summed so that higher scores reflect higher satisfaction with treatment. The possible range of scores is 8-32.

Brief Pain Inventory Pain Interference

Time Frame: past 7 days

BPI consists of 11-point scale items that reflect pain severity and pain interference Pain interference is measured as the mean of 7-items, each rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10

Alcohol Time Line Follow Back...Heavy Drinking Episodes

Time Frame: past 30 days

number of heavy drinking episodes in the past 30 days

Perceptions of Treatment Questionnaire

Time Frame: past 30 days

Participants were asked about their experiences with different facets of the intervention using items that were scored from 0 - 8 with higher scores reflecting greater satisfaction with the treatment components.

Secondary Outcomes

  • Goal Systems Assessment Battery-Alcohol(past 30 days)
  • Goal Systems Assessment Battery-Pain(past 30 days)

Study Sites (1)

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