Using Telephone Technology to Prevent Relapse After Alcoholism Treatment (ATIVR)

June 20, 2012 updated by: John E. Helzer, MD, University of Vermont

Therapeutic IVR to Augment CBT in Alcohol Dependence

The purpose of this study is to determine whether a telephone based self-help program will prevent relapse among individuals undergoing standard substance abuse treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Relapse rates in the first few months following substance abuse treatment are as high as 50%, in spite of the immediate effectiveness of treatments such as Cognitive Behavioral Therapy (CBT). Continuing use of therapy skills following treatment is associated with maintenance of treatment gains. We have programmed a telephone to deliver pre-recorded summaries and rehearsal sessions of skills learned in therapy. The system also includes monthly feedback messages from therapists. We expect that this ad-lib access to therapy skills would allow patients to generalize skills to their personal post-treatment lives. It would also allow individuals in remote or rural areas to obtain access to assistance without travel barriers.

Comparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention).

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 2

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
    • Vermont
      • Burlington, Vermont, United States, 05403
        • UVM Health Behavior Research Center

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets current DSM-IV criteria for alcohol dependence
  • Active drinking during the three months prior to entry into treatment
  • Minimum age of 19
  • Minimum sixth grade reading level.

Exclusion Criteria:

  • Meets criteria for a current psychotic illness
  • Imminent plans to move or be incarcerated
  • Presence of such severe hearing, visual, or cognitive deficit(s) that participation in CBT or use of an Interactive Voice Response (IVR) system are not possible
  • Inability to identify at least one "locator" person to assist in tracking for follow-up assessments
  • Does not have telephone service within the home
  • Incarceration while in active protocol in the study
  • Attendance of less than 8 of 12 CBT sessions

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Therapeutic Phone System
patients assigned to this condition will have unlimited access to the therapeutic telephone system for 4 months.
Behavioral: Daily monitoring of alcohol & drug use, & therapy skills
Comparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention).
Other Names:
  • relapse prevention
Active Comparator: 2 Standard care
Standard post-CBT care (i.e., no formal relapse prevention or professional treatment).
Behavioral: control group
standard care (no added treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of alcohol and use
Time Frame: 4 months and one year
drinks per day, drinks per drinking day, percent days abstinent, heavy drinking days
4 months and one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utilization of the telephone system components during the study
Time Frame: 4 months and one year
call rate, access of coping skills reviews and practices, access of monthly messages.
4 months and one year

Collaborators and Investigators

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

Sponsor

University of Vermont

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: John E. Helzer, MD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

May 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

August 19, 2005

First Submitted That Met QC Criteria

August 19, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 20, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAHEL014270
  • R01AA014270 (U.S. NIH Grant/Contract)

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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