Internet-based Videoconferencing to Address Alcohol Use and Pain

Not Applicable

Completed

Conditions: Chronic Pain
Alcohol Use, Unspecified

Interventions: Behavioral: Motivation and Cognitive Behavioral Management for Alcohol and Pain

Registration Number: NCT03982433

Lead Sponsor: Boston University Charles River Campus

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Motivation and Cognitive Behavioral Management for Alcohol and Pain	participants all receive the intervention

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory Pain Severity	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	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]	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	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	past 30 days	number of heavy drinking episodes in the past 30 days
Perceptions of Treatment Questionnaire	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 Outcome Measures

Name	Time	Method
Goal Systems Assessment Battery-Alcohol	past 30 days	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.
Goal Systems Assessment Battery-Pain	past 30 days	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.