Computer-Based Training in Cognitive Behavior Therapy (CBT4CBT)

Substance-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406899
• Other study ID #: JC0008
• Status: Completed
• Phase: Phase 1
• First received: July 27, 2011
• Last updated: December 22, 2014
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2012
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Connecticut VA Healthcare System	Newington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in substance use	percent days abstinent, confirmed by urine toxicology screens	8 weeks	No
Secondary	Retention in treatment	did patient continued to be enrolled in substance abuse treatment at follow-up	6 months	No