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Internet-based Videoconferencing to Address Alcohol Use and Pain

NCT ID: NCT03982433

Last Updated: 2019-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-06-27

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.

Conditions

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Chronic Pain Alcohol Use, Unspecified

Keywords

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HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants all undergo assessment and intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

participants all receive the intervention

Group Type EXPERIMENTAL

Motivation and Cognitive Behavioral Management for Alcohol and Pain

Intervention Type BEHAVIORAL

Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference

Interventions

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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

Intervention Type BEHAVIORAL

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
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

Principal Investigators

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Tibor P Palfai, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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General Clinical Research Unit, Boston University

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Palfai TP, Kratzer MPL, Taylor JL, Otis JD, Winter MR. Addressing Pain and Heavy Drinking among Patients in HIV-Care: A Pilot Study of an Integrated Telehealth Intervention. AIDS Behav. 2025 Jun;29(6):1930-1943. doi: 10.1007/s10461-025-04660-8. Epub 2025 Feb 25.

Reference Type DERIVED
PMID: 39998790 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UH2AA026192

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4546

Identifier Type: -

Identifier Source: org_study_id