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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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
History of Changes
  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:

MedlinePlus related topics: Alcoholism
U.S. FDA Resources

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
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: John E. Helzer, MD University of Vermont
  More Information

Additional Information:
Investigator's home page  This link exits the ClinicalTrials.gov site

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 June 17, 2013