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Clinical Trials/NCT00132795
NCT00132795CompletedPhase 2

Therapeutic IVR to Augment CBT in Alcohol Dependence

University of Vermont2 sites in 1 country158 target enrollmentStarted: May 2005Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
158
Locations
2
Primary Endpoint
Amount of alcohol and use

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Utilization of the telephone system components during the study(4 months and one year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

John E. Helzer, MD

Professor of Psychiatry

University of Vermont

Study Sites (2)

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