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

NCT ID: NCT04441593

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-23

Study Completion Date

2024-02-02

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

Conditions

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Alcohol Drinking and Chronic Pain Intervention Control Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Compare Intervention to Control Condition in a Between Subjects Design
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Three and six month assessments will be conducted by RA who is masked to intervention condition

Study Groups

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Intervention

Videoconferencing Intervention for Heavy Drinking and Chronic Pain

Group Type EXPERIMENTAL

Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)

Intervention Type BEHAVIORAL

Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity

Control

Treatment as Usual

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type BEHAVIORAL

Psychoeducation and Information about Treatment Resources

Interventions

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Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)

Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity

Intervention Type BEHAVIORAL

Treatment as Usual

Psychoeducation and Information about Treatment Resources

Intervention Type BEHAVIORAL

Other Intervention Names

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Intervention Control

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Boston University Charles River Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Boston University Department of Psychological and Brain Sciences

Boston, Massachusetts, United States

Site Status

General Clinical Research Unit, Boston University

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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UH3AA026192

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4546 [Study 3]

Identifier Type: -

Identifier Source: org_study_id

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