Using Telephone Technology to Prevent Relapse After Alcoholism Treatment

Alcoholism Clinical Trial

— ATIVR  

Official title:

Therapeutic IVR to Augment CBT in Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132795
• Other study ID #: NIAAAHEL014270
• Secondary ID: R01AA014270
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2005
• Last updated: June 20, 2012
• Start date: May 2005
• Est. completion date: July 2010

Study information

• Verified date: June 2012
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: July 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcoholism

Intervention

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).
• control group
standard care (no added treatment)

Locations

Country	Name	City	State
United States	UVM Health Behavior Research Center	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of alcohol and use	drinks per day, drinks per drinking day, percent days abstinent, heavy drinking days	4 months and one year	No
Secondary	Utilization of the telephone system components during the study	call rate, access of coping skills reviews and practices, access of monthly messages.	4 months and one year	No