Computer-Based Training in Cognitive Behavior Therapy (CBT4CBT)

December 22, 2014 updated by: VA Connecticut Healthcare System

Computer-Assisted Cognitive Behavior Therapy for Veterans With Substance Use Disorder

In this behavioral trial 80 substance abusing individuals will be randomly assigned to either treatment as usual in the substance abuse clinic of the Newington, CT VA hospital OR treatment as usual plus 8 hours of access to the 'CBT for CBT' computer program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in substance use (percent days abstinent, confirmed by urine toxicology screens). The patients' ability to demonstrate coping skills through a computerized role-play evaluation will be a secondary outcome. A six-month follow-up will assess durability and/or delayed emergence of effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This pilot study aims to evaluate the feasibility and effectiveness of adding a computer based training program in Cognitive Behavior Therapy ("CBT4CBT") for the treatment of addictions in a VA substance abuse outpatient clinic. Key secondary aims are to assess the impact of adding CBT4CBT to standard care on treatment attendance, engagement, retention, and to investigate if certain process measures are associated with substance use outcomes. Approximately 80 patients enrolled in the Newington Outpatient Substance Abuse Treatment Program (SATP) will be randomly assigned to either (A) treatment as usual, or (B) treatment as usual plus exposure to the CBT4CBT program.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Newington, Connecticut, United States, 06111
        • Connecticut VA Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years and older
  • Recent (within 3 months) substance use
  • meet current DSM-IV (Diagnostic and Statistical Manual-IV) criteria for substance use disorder
  • fluent in English or at least a 6th grade reading level
  • can commit to at least 8 weeks of treatment and willing to be randomized to treatment

Exclusion Criteria:

  • Unstable housing situation
  • Likelihood of going to prison during the intervention portion of study
  • Recent opiate or benzodiazepine prescription

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as Usual
Standard treatment as usual (TAU) in the VA Connecticut Healthcare System substance abuse clinic consisting of individual and group therapy sessions and regular urine monitoring.
Experimental: Computer-based treatment
Standard treatment as usual (TAU) plus coping skills computer program. In addition to the individual and group therapy sessions (TAU), individuals will work with a computerized program that teaches skills for stopping substance use and increasing coping skills twice weekly for 8 weeks.
Behavioral: Computer Based Treatment
Standard treatment as usual (TAU) plus coping skills computer program. In addition to the individual and group therapy sessions (TAU), individuals will work with a computerized program that teaches skills for stopping substance use and increasing coping skills twice weekly for 8 weeks.
Other Names:
  • Cognitive Behavioral Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in substance use
Time Frame: 8 weeks
percent days abstinent, confirmed by urine toxicology screens
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in treatment
Time Frame: 6 months
did patient continued to be enrolled in substance abuse treatment at follow-up
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Connecticut Healthcare System

Investigators

  • Study Director: Kathleen Carroll, Ph.D., Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 27, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimate)

August 1, 2011

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JC0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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