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

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Daily monitoring of alcohol & drug use, & therapy skills
control group
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcoholism focused on measuring Cognitive Therapy, Recurrence, Prevention, Educational Technology

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UVM Health Behavior Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 Therapeutic Phone System

2 Standard care

Arm Description

patients assigned to this condition will have unlimited access to the therapeutic telephone system for 4 months.

Standard post-CBT care (i.e., no formal relapse prevention or professional treatment).

Outcomes

Primary Outcome Measures

Amount of alcohol and use
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
call rate, access of coping skills reviews and practices, access of monthly messages.

Full Information

First Posted
August 19, 2005
Last Updated
June 20, 2012
Sponsor
University of Vermont
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00132795
Brief Title
Using Telephone Technology to Prevent Relapse After Alcoholism Treatment
Acronym
ATIVR
Official Title
Therapeutic IVR to Augment CBT in Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Cognitive Therapy, Recurrence, Prevention, Educational Technology

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Therapeutic Phone System
Arm Type
Experimental
Arm Description
patients assigned to this condition will have unlimited access to the therapeutic telephone system for 4 months.
Arm Title
2 Standard care
Arm Type
Active Comparator
Arm Description
Standard post-CBT care (i.e., no formal relapse prevention or professional treatment).
Intervention Type
Behavioral
Intervention Name(s)
Daily monitoring of alcohol & drug use, & therapy skills
Other Intervention Name(s)
relapse prevention
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
control group
Intervention Description
standard care (no added treatment)
Primary Outcome Measure Information:
Title
Amount of alcohol and use
Description
drinks per day, drinks per drinking day, percent days abstinent, heavy drinking days
Time Frame
4 months and one year
Secondary Outcome Measure Information:
Title
Utilization of the telephone system components during the study
Description
call rate, access of coping skills reviews and practices, access of monthly messages.
Time Frame
4 months and one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E. Helzer, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVM Health Behavior Research Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.med.uvm.edu/hbrc/
Description
Investigator's home page

Learn more about this trial

Using Telephone Technology to Prevent Relapse After Alcoholism Treatment

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