Clinical trial NCT03982433: Internet-based Videoconferencing to Address Alcohol Use and Pain
Official title: Internet-based Video-conferencing to Address Alcohol Use and Pain Among Heavy Drinkers in HIV-care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Alcohol Use, Unspecified
Keywords: HIV
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-06-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants all undergo assessment and intervention
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Brief Pain Inventory Pain Severity
timeFrame: past 7 days
measure: Brief Pain Inventory Pain Interference
timeFrame: past 7 days
measure: Alcohol Time Line Follow Back...Heavy Drinking Episodes
timeFrame: past 30 days
measure: Alcohol Time Line Follow Back...Average Drinks Per Week
timeFrame: past 30 days
measure: Client Satisfaction Questionnaire-8 [Modified]
timeFrame: past 30 days
measure: Perceptions of Treatment Questionnaire
timeFrame: past 30 days
Secondary outcomes:
measure: Goal Systems Assessment Battery-Pain
timeFrame: past 30 days
measure: Goal Systems Assessment Battery-Alcohol
timeFrame: past 30 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: General Clinical Research Unit, Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Tibor P Palfai, PhD
role: PRINCIPAL_INVESTIGATOR
References: