Computer Based Training in Cognitive Behavioral Therapy Web-based

Substance Abuse Clinical Trial

— Man VS Machine  

Official title:

Computer Based Training in Cognitive Behavioral Therapy Web-based

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442597
• Other study ID #: 1004006632
• Secondary ID: 2P50DA009241-21
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2012
• Est. completion date: January 2018

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Abuse
• Substance-Related Disorders

Intervention

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.
• Individual clinician-provided CBT
Individual drug counseling sessions with trained clinicians using CBT one time per week last one hour per session.
• 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.

Locations

Country	Name	City	State
United States	Substance Abuse Treatment Unit (SATU)	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in drug abuse		12 weeks
Secondary	Subjects ability to demonstrate coping skills through a computerized role-playing evaluation		12 weeks