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Using Telephone Technology to Prevent Relapse After Alcoholism Treatment

This study is currently recruiting participants.
Verified by National Institute on Alcohol Abuse and Alcoholism (NIAAA), September 2008

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00132795
  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
Device: Alcohol Therapeutic Interactive Voice Response System
Phase II

MedlinePlus related topics:   Alcoholism   

Drug Information available for:   Ethanol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Therapeutic IVR to Augment CBT in Alcohol Dependence

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • Amount of alcohol and drug use [ Time Frame: 4 months and one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Utilization of the telephone system components during the study [ Time Frame: 4 months and one year ] [ Designated as safety issue: No ]

Estimated Enrollment:   200
Study Start Date:   May 2005
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1 Therapeutic Phone System: Active Comparator
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).
Device: Alcohol Therapeutic Interactive Voice Response System
Patients will have unlimited access to the therapeutic telephone system for 4 months.
2 Standard care: Active Comparator
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).
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).

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

Contacts
Contact: Gail L. Rose, Ph.D.     802-847-1430     Gail.Rose@vtmednet.org    

Locations
United States, Vermont
UVM Health Behavior Research Center     Recruiting
      South Burlington, Vermont, United States, 05403
      Contact: Gail L. Rose, Ph.D.     802-847-1430     Gail.Rose@vtmednet.org    
      Principal Investigator: John E. Helzer, MD            

Sponsors and Collaborators

Investigators
Principal Investigator:     John E. Helzer, MD     University of Vermont    
  More Information


Responsible Party:   The University of Vermont ( John E. Helzer, M.D., Principal Investigator )
Study ID Numbers:   NIAAAHEL014270, NIH Grant 5 R01 AA014270-02
First Received:   August 19, 2005
Last Updated:   September 26, 2008
ClinicalTrials.gov Identifier:   NCT00132795
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Cognitive Therapy  
Recurrence  
Prevention  
Educational Technology  

Study placed in the following topic categories:
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Recurrence
Ethanol

ClinicalTrials.gov processed this record on November 05, 2008




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