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

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

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.

Study Overview

• Status: Completed
• Conditions: Control Condition; Alcohol Drinking and Chronic Pain Intervention
• Intervention / Treatment: Behavioral: Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP); Behavioral: Treatment as Usual

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

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University Department of Psychological and Brain Sciences
    • 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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Actual): February 2, 2024
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Pain; Neurologic Manifestations; Alcohol Drinking; Chronic Pain
• Other Study ID Numbers: 4546 [Study 3]; UH3AA026192 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For proposals that contain analyses that are not already planned or in progress, the investigators will make data available for collaboration with a study investigator, provided IRB and other appropriate regulatory approvals are obtained (including but not limited to Federal and Boston University IRB review and approval). Data to be shared will be de-identified to minimize the risk of deductive disclosure. Documentation will be provided for all shared data including copies of data collection forms, schedule of study assessments, data dictionaries documenting all original and derived variables, descriptive statistics for all variables included in the data sets, and a written description of the study conduct and noteworthy details anticipated to potentially affect data interpretation. Costs associated with producing data sets and analysis will be the responsibility of investigators seeking the data.
• IPD Sharing Time Frame: Twelve months following request, de-identified data will be available to investigators upon request. This access will be provided for 7 years following publication of main trial
• IPD Sharing Access Criteria: Specific data may be shared based on proposals received and reviewed by the study investigators and determined to have scientific merit. Limited public-use data sets may also be prepared and made available in a web-data archive to be developed and maintained by the data coordinating center (BEDAC).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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