Web-based CBT4CBT for Alcohol

Alcohol Abuse or Dependence Clinical Trial

— CBT4CBT Etoh  

Official title:

Computer Based Training in Cognitive Behavioral Therapy Web-based Delivery of CBT4CBT for Alcohol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615497
• Other study ID #: 1204010157
• Secondary ID: R21AA021405-01
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: June 2015

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 (Computer Based Training for Cognitive Behavioral Therapy) program specifically designed for alcohol to evaluate its effectiveness relative to standard outpatient counseling at the Substance Abuse Treatment Unit (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:

Ninety alcohol 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) standard outpatient counseling plus web-based CBT, or (3) web-based CBT4CBT with minimal clinical monitoring. Treatments will be delivered over an 8-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in alcohol use (frequency of alcohol use by time, confirmed by urine toxicology screens and breathalyzers). 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: 68
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 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 alcohol abuse or dependence.

• Are sufficiently stable for 8 weeks of outpatient treatment.

• Can commit to 8 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 8-week protocol is likely.

• Are physically dependent on alcohol, opioids or benzodiazepines

Related Conditions & MeSH terms

• Alcohol Abuse or Dependence
• Alcoholism

Intervention

Behavioral:
• Standard Treatment as Usual (TAU)
Treatment normally offered at this clinic which could include individual or group alcohol and drug counseling sessions one time per week lasting one hour each time.
• Web-based CBT4CBT for alcohol plus TAU
Subjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus TAU
• Web-based CBT with minimal clinical contact
Subjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus 10 minute check in with clinician.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA), 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 alcohol use		8 weeks
Secondary	Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework		8 weeks