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Clinical Trials/NCT03758274
NCT03758274CompletedNot Applicable

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

University of Rochester1 site in 1 country400 target enrollmentStarted: March 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
400
Locations
1
Primary Endpoint
Days Abstinent

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes 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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

CBT Phone Intervention

Experimental

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

Intervention: CBT by Phone to Promote Treatment (Behavioral)

Being Read A Pamphlet on Alcohol Treatment

Active Comparator

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

Intervention: Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment (Other)

Outcomes

Primary Outcomes

Days Abstinent

Time Frame: prior 30 days (at 3-month follow-up)

Number of days abstinent from alcohol use in prior 30 days

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kenneth Conner

Professor, Emergency Medicine

University of Rochester

Study Sites (1)

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