NCT03474588

Brief Summary

Specific aims are as follows:

  • To adapt our existing CBT4CBT program for use with Spanish-speaking alcohol users in a web-based platform
  • To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT-Spanish to treatment as usual in a community based treatment program in a population of 90 Spanish-speaking individuals who meet current criteria for alcohol use disorder
  • To evaluate the long-term durability and/or delayed emergence of treatment effects through a six month follow-up after termination of the study treatments. Given previous evidence regarding the durability of standard clinician-delivered CBT and computer-assisted CBT4CBT, we hypothesize that CBT4CBTSpanish will be significantly more effective than standard treatment alone through the follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

5 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

First Submitted

Initial submission to the registry

March 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 6, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 26, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

4 years

First QC Date

March 15, 2018

Results QC Date

August 15, 2024

Last Update Submit

November 18, 2024

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

  • The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week

    The primary outcome measure will be percent days of abstinence (PDA) by week, presented are the raw means at each time point.

    By week for 8 weeks

  • Monthly Abstinence From Alcohol

    Estimated means of sustained abstinence calculated as percent days per month from month 3 through 8 in post intervention follow up.

    Months 3 through 8 (6 months total)

Secondary Outcomes (2)

  • Secondary Outcomes Include Percent Heavy Drinking Days

    8 weeks

  • Number of Individuals With no Heavy Drinking Days in the Last 4 Weeks of Treatment

    last 4 weeks of treatment (4 weeks)

Study Arms (2)

Standard Treatment (ST)

ACTIVE COMPARATOR

This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as: * Teaching about the treatment program * Teaching important ideas about recovery * Increasing knowledge about specific problems about addiction * Demonstrating new ways of coping with skills designed to fit each participant

Behavioral: Standard Treatment (ST)

2. Standard treatment (ST) PLUS web-based CBT4CBT

EXPERIMENTAL

This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as: * Teaching about the treatment program * Teaching important ideas about recovery * Increasing knowledge about specific problems about addiction * Demonstrating new ways of coping with skills designed to fit each participant PLUS Participants will have access the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on.

Behavioral: Standard treatment (ST) PLUS web-based CBT4CBT

Interventions

Standard treatment (ST) PLUS web-based CBT4CBTBEHAVIORAL

Participants will have access to the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on

2. Standard treatment (ST) PLUS web-based CBT4CBT
Standard Treatment (ST)BEHAVIORAL

ST includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks

Standard Treatment (ST)

Eligibility Criteria

Age18 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 alcohol treatment, with some alcohol use in the past 30 days
  • Speak Spanish as their preferred or principal (most commonly spoken) language.
  • 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.

You may not qualify if:

  • Have an untreated bipolar or schizophrenic disorder
  • Have a current legal case pending such that incarceration during the 8 week protocol is likely
  • Meet DSM-5 criteria for another current substance use disorder (other than nicotine).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Midwestern Connecticut Council on Alcoholism (MCCA)

Bridgeport, Connecticut, 06511, United States

Location

Cornell Scott - Hill Health Center

New Haven, Connecticut, 06511, United States

Location

Hispanic Clinic of CMHC

New Haven, Connecticut, 06511, United States

Location

Midwestern Connecticut Council on Alcoholism (MCCA)

New Haven, Connecticut, 06511, United States

Location

Multi-Cultural Ambulatory Addiction Services (MAAS)

New Haven, Connecticut, 06511, 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

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Brian Kiluk, Ph.D.
Organization
Yale University Department of Psychiatry
brian.kiluk@yale.edu
203-737-1544

Study Officials

  • Manuel Paris, PsyD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

March 15, 2018

First Posted

March 22, 2018

Study Start

August 6, 2019

Primary Completion

August 16, 2023

Study Completion

August 16, 2023

Last Updated

November 26, 2024

Results First Posted

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(5)