Internet-based Videoconferencing to Address Alcohol Use and Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain, Alcohol Use, Unspecified

Intervention / Treatment
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* Behavioral: Motivation and Cognitive Behavioral Management for Alcohol and Pain


Participation Criteria
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Eligibility Criteria
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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

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
Intervention Model: Single Group Assignment
Interventional Model Description: Participants all undergo assessment and intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>participants all receive the intervention | Behavioral: Motivation and Cognitive Behavioral Management for Alcohol and Pain<br>* Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory Pain Severity | 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 | past 7 days | 
| Brief Pain Inventory Pain Interference | 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 | past 7 days | 
| Alcohol Time Line Follow Back...Heavy Drinking Episodes | number of heavy drinking episodes in the past 30 days | past 30 days | 
| Alcohol Time Line Follow Back...Average Drinks Per Week | average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28) | past 30 days | 
| Client Satisfaction Questionnaire-8 [Modified] | 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. | past 30 days | 
| Perceptions of Treatment Questionnaire | 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. | past 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goal Systems Assessment Battery-Pain | Ratings self-regulatory capacities related to pain. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes. | past 30 days | 
| Goal Systems Assessment Battery-Alcohol | Ratings self-regulatory capacities related to moderating alcohol use. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes. | past 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV