NCT02043210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2017

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

3.6 years

First QC Date

January 10, 2014

Last Update Submit

March 4, 2020

Conditions

Substance Use

Keywords

substance use, Spanish speaking, CBT4CBT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework

    8 weeks

Study Arms (2)

Standard Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Standard Treatment as Usual

CBT4CBT plus Standard treatment as usual

EXPERIMENTAL

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.

Behavioral: CBT4CBT plus Standard treatment as usual

Interventions

Standard Treatment as UsualBEHAVIORAL

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.

Standard Treatment as Usual
CBT4CBT plus Standard treatment as usualBEHAVIORAL

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

CBT4CBT plus Standard treatment as usual

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fair Haven Community Health

New Haven, Connecticut, 06511, United States

Location

MAAS

New Haven, Connecticut, 06511, United States

Location

Hispanic Clinic

New Haven, Connecticut, 06519, United States

Location

Substance Abuse Treatment Unit (SATU)

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Benitez B, Frankforter T, Nich C, Paris M, Kiluk BD. Comparing content within a culturally-adapted digital treatment for Hispanic patients with alcohol use disorder. NPJ Digit Med. 2025 Dec 8;9(1):23. doi: 10.1038/s41746-025-02197-7.

    PMID: 41361015DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Kathleen Carroll, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 23, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2017

Study Completion

September 11, 2017

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

US(4)