Internet-based Videoconferencing to Address Alcohol Use and Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Alcohol Use, Unspecified
• Intervention / Treatment: Behavioral: Motivation and Cognitive Behavioral Management for Alcohol and Pain

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • General Clinical Research Unit, Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Tibor P Palfai, PhD, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 27, 2019
• Study Completion (Actual): June 27, 2019

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: HIV
• Additional Relevant MeSH Terms: Drinking Behavior; Pain; Neurologic Manifestations; Alcohol Drinking; Chronic Pain
• Other Study ID Numbers: 4546 (Other Identifier: VA Portland Health Care System); UH2AA026192 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No