Clinical trial NCT02043210: CBT for Spanish Speakers
Official title: Computer Based Training in CBT for Spanish-speaking Substance Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Keywords: substance use, Spanish speaking, CBT4CBT
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-01-23
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction in substance use
timeFrame: 8 weeks
Secondary outcomes:
measure: Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Fair Haven Community Health
state: Connecticut
city: New Haven
country: United States
facility: MAAS
state: Connecticut
city: New Haven
country: United States
facility: Hispanic Clinic
state: Connecticut
city: New Haven
country: United States
facility: Substance Abuse Treatment Unit (SATU)
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathleen Carroll, PhD
role: PRINCIPAL_INVESTIGATOR
References: