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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Alcohol Drinking and Chronic Pain Intervention, Control Condition

Intervention / Treatment
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* Behavioral: Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Compare Intervention to Control Condition in a Between Subjects Design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Videoconferencing Intervention for Heavy Drinking and Chronic Pain | Behavioral: Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)<br>* Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity<br>* Other names: Intervention;|
| Active Comparator: Control<br>Treatment as Usual | Behavioral: Treatment as Usual<br>* Psychoeducation and Information about Treatment Resources<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes | Number of heavy drinking episodes NIAAA criteria (5+drinks men/ 4+ drinks women) | Past 30 days | 
| Alcohol Time Line Follow-Back (30) - Average Drinks per Week | Average number of standard alcohol-containing drinks in the past 30 days | Past 30 days | 
| Brief Pain Inventory - Pain Severity | BPI is an 11-point scale anchored with 0 best and 10 is worst Scale range 0-10 | Past 7 days | 
| Brief Pain Inventory - Pain Interference | 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 | Past 7-Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Inventory of Alcohol Problems-Revised | 17-item measure with 4-point Likert scale items ranging from 0 never to 3 daily/almost daily. Scale range 0-51 | 3 months | 
| Goal Systems Assessment Battery-Alcohol | 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 | Past 30 days | 
| Goal Systems Assessment Battery-Pain | 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 | Past 30 days |