Computer Based Training in Cognitive Behavioral Therapy Web-based (Man VS Machine)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01442597
First received: September 26, 2011
Last updated: September 11, 2014
Last verified: September 2014

September 26, 2011
September 11, 2014
January 2012
December 2016   (final data collection date for primary outcome measure)
Reduction in drug abuse [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01442597 on ClinicalTrials.gov Archive Site
Subjects ability to demonstrate coping skills through a computerized role-playing evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Computer Based Training in Cognitive Behavioral Therapy Web-based
Computer Based Training in Cognitive Behavioral Therapy Web-based

The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT program to evaluate its effectiveness relative to standard outpatient counseling at SATU. The computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.

One hundred eighty drug-using individuals seeking treatment at the Substance Abuse Treatment Unit (SATU) of the Connecticut Mental Health Center will be randomized to (1) standard outpatient counseling at SATU (typically consisting of weekly group counseling), (2) individual clinician delivered CBT, or (3) web-based CBT4CBT. Treatments will be delivered over a 12-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in substance use (frequency of drug use by time, confirmed by urine toxicology screens). Secondary outcomes will include treatment utilization and cost, several measures intended to detect whether web-based CBT4CBT retains key characteristics of traditional clinician-administered CBT (e.g., acquisition of coping skills, use of change strategies), participant characteristics which will be evaluated as potential moderators of outcome, as well as participant satisfaction and treatment credibility.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Substance Abuse
  • Behavioral: Standard Treatment As Usual (TAU)
    Treatment normally offered at this clinic which could include individual or group drug counseling sessions one time per week last one hour each time.
  • Behavioral: Individual clinician-provided CBT
    Individual drug counseling sessions with trained clinicians using CBT one time per week last one hour per session.
  • Behavioral: CBT4CBT
    Subjects work with a computerized program that teaches skills for stopping drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session.
  • Active Comparator: Individual clinician-provided CBT
    Individual treatment provided by a trained Cognitive Behavioral Therapy (CBT)clinician who will cover the same skills provided by the CBT4CBT computer program.
    Intervention: Behavioral: Individual clinician-provided CBT
  • Experimental: CBT4CBT
    A computerized program that teaches skills for stopping drug use and increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc.
    Intervention: Behavioral: CBT4CBT
  • Active Comparator: Standard Treatment as Usual (TAU)
    Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on substance abuse.
    Intervention: Behavioral: Standard Treatment As Usual (TAU)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Are 18 years of age or older.
  • Are applying for outpatient, non-agonist substance abuse treatment at SATU.
  • Meet current DSM-IV criteria for cocaine, marijuana,opioid,or amphetamine dependence.
  • Are sufficiently stable for 12 weeks of outpatient treatment.
  • Can commit to 12 weeks of treatment and are willing to be randomized to treatment
  • Are willing to provide locator information for follow-up.
  • Are fluent in English and have a 6th grader or higher reading level

Exclusion Criteria:

  • Have an untreated bipolar or schizophrenic disorder.
  • Who have a current legal case pending such that incarceration during 12-week protocol is likely.
  • Are physically dependent on alcohol, opioids or benzodiazepines
Both
18 Years to 65 Years
No
Contact: Elizabeth Vollono, MSW 203-974-5732 elizabeth.vollono@yale.edu
United States
 
NCT01442597
1004006632
Yes
Yale University
Yale University
Not Provided
Principal Investigator: Kathleen Carroll, PhD Yale University
Yale University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP