CBT for Spanish Speakers

NCT ID: NCT02043210

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-09-11

Brief 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.

Detailed 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.

Conditions

Substance Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Treatment as Usual

Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on substance abuse.

Group Type: ACTIVE_COMPARATOR

Standard Treatment as Usual

Intervention Type: BEHAVIORAL

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

A computerized program that teaches skills for stopping substance use by increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc. plus standard treatment as usual.

Group Type: EXPERIMENTAL

CBT4CBT plus Standard treatment as usual

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Carroll, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Fair Haven Community Health

New Haven, Connecticut, United States

MAAS

New Haven, Connecticut, United States

Hispanic Clinic

New Haven, Connecticut, United States

Substance Abuse Treatment Unit (SATU)

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1R01DA030369-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1110009151

Identifier Type: -

Identifier Source: org_study_id