Computer-Based Training in Cognitive Behavior Therapy (CBT4CBT)
Primary Purpose
Substance-Related Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computer Based Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Substance-Related Disorders
Eligibility Criteria
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
Sites / Locations
- Connecticut VA Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment as Usual
Computer-based treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Reduction in substance use
percent days abstinent, confirmed by urine toxicology screens
Secondary Outcome Measures
Retention in treatment
did patient continued to be enrolled in substance abuse treatment at follow-up
Full Information
NCT ID
NCT01406899
First Posted
July 27, 2011
Last Updated
December 22, 2014
Sponsor
VA Connecticut Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT01406899
Brief Title
Computer-Based Training in Cognitive Behavior Therapy (CBT4CBT)
Official Title
Computer-Assisted Cognitive Behavior Therapy for Veterans With Substance Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
Computer-based treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computer Based Treatment
Other Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in substance use
Description
percent days abstinent, confirmed by urine toxicology screens
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Retention in treatment
Description
did patient continued to be enrolled in substance abuse treatment at follow-up
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Carroll, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
Connecticut VA Healthcare System
City
Newington
State/Province
Connecticut
ZIP/Postal Code
06111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Computer-Based Training in Cognitive Behavior Therapy (CBT4CBT)
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