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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John E. Helzer, MD, University of Vermont
ClinicalTrials.gov Identifier:
NCT00132795
First received: August 19, 2005
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Alcoholism
Behavioral: Daily monitoring of alcohol & drug use, & therapy skills
Behavioral: control group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Therapeutic IVR to Augment CBT in Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Amount of alcohol and use [ Time Frame: 4 months and one year ] [ Designated as safety issue: No ]
    drinks per day, drinks per drinking day, percent days abstinent, heavy drinking days


Secondary Outcome Measures:
  • Utilization of the telephone system components during the study [ Time Frame: 4 months and one year ] [ Designated as safety issue: No ]
    call rate, access of coping skills reviews and practices, access of monthly messages.


Enrollment: 158
Study Start Date: May 2005
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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)
Other Name: Control group

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).

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132795

Locations
United States, Vermont
UVM Health Behavior Research Center
Burlington, Vermont, United States, 05403
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: John E. Helzer, MD University of Vermont
  More Information

Additional Information:
No publications provided

Responsible Party: John E. Helzer, MD, Professor of Psychiatry, University of Vermont
ClinicalTrials.gov Identifier: NCT00132795     History of Changes
Other Study ID Numbers: NIAAAHEL014270, R01AA014270
Study First Received: August 19, 2005
Last Updated: June 20, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Vermont:
Cognitive Therapy
Recurrence
Prevention
Educational Technology

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014