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Talk Therapy by Phone to Promote Treatment for Alcohol Problems

Primary Purpose

Alcohol Use Disorder, Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT by Phone to Promote Treatment
Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT Phone Intervention

Being Read A Pamphlet on Alcohol Treatment

Arm Description

Cognitive-Behavioral Therapy for Treatment Seeking, CBT-TS, a manualized behavioral intervention, administered by telephone in a single session.

Guided review of a National Institute on Alcohol Abuse and Alcoholism (NIAAA) pamphlet on AUD treatment, administered by telephone in a single session.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 27, 2018
Last Updated
October 3, 2023
Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Medical University of South Carolina, Syracuse University
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1. Study Identification

Unique Protocol Identification Number
NCT03758274
Brief Title
Talk Therapy by Phone to Promote Treatment for Alcohol Problems
Official Title
Cognitive Behavioral Treatment by Phone to Promote Use of Alcohol Related Care and Reduce Drinking
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
July 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Medical University of South Carolina, Syracuse University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Alcohol Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The University of Rochester based study team, led by MPI Conner, were masked to treatment assignment (which was performed at the Medical University of South Carolina), and the University of Rochester based team performed all follow-up assessments.
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT Phone Intervention
Arm Type
Experimental
Arm Description
Cognitive-Behavioral Therapy for Treatment Seeking, CBT-TS, a manualized behavioral intervention, administered by telephone in a single session.
Arm Title
Being Read A Pamphlet on Alcohol Treatment
Arm Type
Active Comparator
Arm Description
Guided review of a National Institute on Alcohol Abuse and Alcoholism (NIAAA) pamphlet on AUD treatment, administered by telephone in a single session.
Intervention Type
Behavioral
Intervention Name(s)
CBT by Phone to Promote Treatment
Intervention Description
Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles.
Intervention Type
Other
Intervention Name(s)
Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Drinks Per Drinking Day
Description
Average number of standard drinks on days of alcohol consumption at 3-month follow-up
Time Frame
prior 30 days (at 3-month follow-up)
Title
Days Abstinent
Description
Number of days abstinent from alcohol use in prior 30 days
Time Frame
prior 30 days (at 3-month follow-up)
Title
Number Initiating Alcohol Use Disorder Treatment
Description
Number Attending any Alcohol Use Disorder Treatment Session(s) over 3-month follow-up
Time Frame
over 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Talk Therapy by Phone to Promote Treatment for Alcohol Problems

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