CBT4CBT With Spanish Alcohol Users

Computer Based Training in CBT for Spanish-Speaking Alcohol Users

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Standard Treatment (ST); Behavioral: Standard treatment (ST) PLUS web-based CBT4CBT

Detailed Description

The investigators will conduct a Stage 1 randomized clinical trial evaluating the program in which 90 Spanish-speaking individuals with alcohol use disorder will be randomized to (1) standard outpatient counseling at the Hispanic Clinic (ST; typically consisting of weekly individual and group supportive counseling) or (2) CBT4CBT-Spanish as an adjunct to ST. Other aspects of the trial will parallel those in the investogators completed trial of the English version of CBT4CBT-Alcohol to facilitate comparability across studies. Treatments will be delivered over an 8-week period with a 6-month follow-up to assess durability and/or delayed emergence of treatment effects. The primary outcome measure will be percent days of abstinence (PDA) by week. Secondary outcomes include percent heavy drinking days and number of individuals with no heavy drinking days in the last 4 weeks of treatment.

Participants will be 90 individuals seeking treatment for alcohol use at the Hispanic Clinic of CMHC. The clinic treats a heterogeneous population, where 42% of those in the co-occurring treatment program report alcohol as their principal substance related issue and 43% are women. As reported above, the investigators have demonstrated the ability to recruit, randomize, retain, and follow-up high numbers of closely related samples in this setting.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06511
      • Midwestern Connecticut Council on Alcoholism (MCCA)
    • New Haven, Connecticut, United States, 06511
      • Cornell Scott - Hill Health Center
    • New Haven, Connecticut, United States, 06511
      • Hispanic Clinic of CMHC
    • New Haven, Connecticut, United States, 06511
      • Midwestern Connecticut Council on Alcoholism (MCCA)
    • New Haven, Connecticut, United States, 06511
      • Multi-Cultural Ambulatory Addiction Services (MAAS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Are 18 years of age or older.
2. Are applying for outpatient alcohol treatment, with some alcohol use in the past 30 days
3. Speak Spanish as their preferred or principal (most commonly spoken) language.
4. Are sufficiently stable for 8 weeks of outpatient treatment
5. Can commit to 8 weeks of treatment and are willing to be randomized to treatment
6. Are willing to provide locator information for follow-up.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Treatment (ST); 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); 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
Experimental: 2. Standard treatment (ST) PLUS web-based CBT4CBT; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	By week for 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcomes include percent heavy drinking days	Percent heavy drinking days during 8 weeks of trial	8 weeks
Number of individuals with no heavy drinking days in the last 4 weeks of treatment	Number of individuals with no heavy drinking days in the last 4 weeks of treatment	last 4 weeks of treatment

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Manuel Paris, PsyD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2019
• Primary Completion (Actual): August 16, 2023
• Study Completion (Actual): August 16, 2023

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 2000020677; R01AA025605 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No