Talk Therapy by Phone to Promote Treatment for Alcohol Problems

October 3, 2023 updated by: Kenneth Conner, University of Rochester

Cognitive Behavioral Treatment by Phone to Promote Use of Alcohol Related Care and Reduce Drinking

A small percentage of individuals with alcohol use disorder (AUD) obtain alcohol-related care despite research showing that treatment is effective. This randomized controlled trial tests the efficacy of a brief, phone based cognitive behavioral intervention to increase treatment engagement, improve alcohol related outcomes, and show that treatment engagement is a mechanism for the improved outcomes in individuals with AUD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 18-plus;
  • score ≥ 16 on AUDIT;
  • within the past 30 days, exceeding the limits for low-risk drinking adopted by NIAAA: >3 standard drinks on any occasion or >7 drinks per week (women); >4 drinks on any occasion or >14 drinks per week (men).

Exclusion Criteria:

  • unable to communicate with the researcher in English;
  • unable to comprehend the nature of the study;
  • history of alcohol-related care;
  • alcohol withdrawal necessitating medical evaluation;
  • residency outside of The Greater Rochester Area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT Phone Intervention
Cognitive-Behavioral Therapy for Treatment Seeking, CBT-TS, a manualized behavioral intervention, administered by telephone in a single session.
Behavioral: CBT by Phone to Promote Treatment
Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles.
Active Comparator: Being Read A Pamphlet on Alcohol Treatment
Guided review of a National Institute on Alcohol Abuse and Alcoholism (NIAAA) pamphlet on AUD treatment, administered by telephone in a single session.
Other: Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment
The pamphlet was created by the National Institute on Alcohol Abuse and Alcoholism to describe evidence based treatments available for alcohol use disorder and how to obtain such treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Drinks Per Drinking Day
Time Frame: prior 30 days (at 3-month follow-up)
Average number of standard drinks on days of alcohol consumption at 3-month follow-up
prior 30 days (at 3-month follow-up)
Days Abstinent
Time Frame: prior 30 days (at 3-month follow-up)
Number of days abstinent from alcohol use in prior 30 days
prior 30 days (at 3-month follow-up)
Number Initiating Alcohol Use Disorder Treatment
Time Frame: over 3 months
Number Attending any Alcohol Use Disorder Treatment Session(s) over 3-month follow-up
over 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Syracuse University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

July 21, 2022

Study Completion (Actual)

July 21, 2022

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB00072850
  • R01AA026815-01 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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