CBT for Spanish Speakers

Substance Use Clinical Trial

Official title:

Computer Based Training in CBT for Spanish-speaking Substance Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043210
• Other study ID #: 1110009151
• Secondary ID: 1R01DA030369-01A
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: September 11, 2017

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) in Spanish. This program specifically designed for Spanish-speaking substance users to evaluate its effectiveness relative to standard outpatient counseling at the Hispanic Clinic. 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 use treatment.

Description:

100 Spanish-speaking substance using individuals seeking treatment at the Hispanic Clinic of the Connecticut Mental Health Center will be randomized to (1) standard outpatient counseling at the Hispanic Clinic (typically consisting of weekly group counseling), OR (2) CBT4CBT plus standard outpatient counseling. 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 substance use (frequency of substance 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: 99
• Est. completion date: September 11, 2017
• Est. primary completion date: August 2017
• 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 the Hispanic Clinic.

• Meet current DSM-IV criteria for cocaine, marijuana, opioid, alcohol or other stimulant 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.

• Speak Spanish as their preferred or principal (most commonly spoken)language

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

• Substance Use

Intervention

Behavioral:
• Standard Treatment as Usual
Treatment normally offered at this clinic which could include individual or group substance use counseling sessions one time per week lasting one hour each time.
• CBT4CBT plus Standard treatment as usual
Subjects work with a computerized program in Spanish that teaches skills for stopping substance use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus Standard treatment as usual

Locations

Country	Name	City	State
United States	Fair Haven Community Health	New Haven	Connecticut
United States	Hispanic Clinic	New Haven	Connecticut
United States	MAAS	New Haven	Connecticut
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 substance use	Reduction in substance use will be measured by Time Line Follow back self report and urine toxicology screening	8 weeks
Secondary	Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework	Computerized role-playing will be used to demonstrate ability to use learned coping skills in various settings.	8 weeks