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

August 19, 2005
June 20, 2012
May 2005
December 2009   (final data collection date for primary outcome measure)
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
Amount of alcohol and drug use 4 months and one year after therapy ends.
Complete list of historical versions of study NCT00132795 on ClinicalTrials.gov Archive Site
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.
Utilization of the telephone system components during the study.
Not Provided
Not Provided
 
Using Telephone Technology to Prevent Relapse After Alcoholism Treatment
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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Alcoholism
  • 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
  • Behavioral: control group
    standard care (no added treatment)
    Other Name: Control group
  • Experimental: 1 Therapeutic Phone System
    patients assigned to this condition will have unlimited access to the therapeutic telephone system for 4 months.
    Intervention: Behavioral: Daily monitoring of alcohol & drug use, & therapy skills
  • Active Comparator: 2 Standard care
    Standard post-CBT care (i.e., no formal relapse prevention or professional treatment).
    Intervention: Behavioral: control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
July 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00132795
NIAAAHEL014270, R01AA014270
No
John E. Helzer, MD, University of Vermont
University of Vermont
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: John E. Helzer, MD University of Vermont
University of Vermont
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP