Clinical trial NCT04441593: Internet-based Video-conferencing to Address Alcohol Use and Pain: a Pilot Trial
Official title: Internet-based Videoconferencing to Address Alcohol Use and Pain Among People With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking and Chronic Pain Intervention
Control Condition
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-06-22
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare Intervention to Control Condition in a Between Subjects Design
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes
timeFrame: Past 30 days
measure: Alcohol Time Line Follow-Back (30) - Average Drinks per Week
timeFrame: Past 30 days
measure: Brief Pain Inventory - Pain Severity
timeFrame: Past 7 days
measure: Brief Pain Inventory - Pain Interference
timeFrame: Past 7-Days
Secondary outcomes:
measure: Short Inventory of Alcohol Problems-Revised
timeFrame: 3 months
measure: Goal Systems Assessment Battery-Alcohol
timeFrame: Past 30 days
measure: Goal Systems Assessment Battery-Pain
timeFrame: Past 30 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Department of Psychological and Brain Sciences
state: Massachusetts
city: Boston
country: United States
facility: General Clinical Research Unit, Boston University
state: Massachusetts
Study officials:
References: