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CBT4CBT With Spanish Alcohol Users

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard treatment (ST) PLUS web-based CBT4CBT
Standard Treatment (ST)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Midwestern Connecticut Council on Alcoholism (MCCA)
  • Cornell Scott - Hill Health Center
  • Hispanic Clinic of CMHC
  • Midwestern Connecticut Council on Alcoholism (MCCA)
  • Multi-Cultural Ambulatory Addiction Services (MAAS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Treatment (ST)

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

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary outcomes include percent heavy drinking days
Percent heavy drinking days during 8 weeks of trial
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

Full Information

First Posted
March 15, 2018
Last Updated
August 17, 2023
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03474588
Brief Title
CBT4CBT With Spanish Alcohol Users
Official Title
Computer Based Training in CBT for Spanish-Speaking Alcohol Users
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
August 16, 2023 (Actual)
Study Completion Date
August 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Treatment (ST)
Arm Type
Active Comparator
Arm Description
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
Arm Title
2. Standard treatment (ST) PLUS web-based CBT4CBT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard treatment (ST) PLUS web-based CBT4CBT
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard Treatment (ST)
Intervention Description
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
Primary Outcome Measure Information:
Title
The primary outcome measure will be percent days of abstinence (PDA) by week
Description
The primary outcome measure will be percent days of abstinence (PDA) by week
Time Frame
By week for 8 weeks
Secondary Outcome Measure Information:
Title
Secondary outcomes include percent heavy drinking days
Description
Percent heavy drinking days during 8 weeks of trial
Time Frame
8 weeks
Title
Number of individuals with no heavy drinking days in the last 4 weeks of treatment
Description
Number of individuals with no heavy drinking days in the last 4 weeks of treatment
Time Frame
last 4 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Paris, PsyD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Midwestern Connecticut Council on Alcoholism (MCCA)
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Cornell Scott - Hill Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Hispanic Clinic of CMHC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Midwestern Connecticut Council on Alcoholism (MCCA)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Multi-Cultural Ambulatory Addiction Services (MAAS)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CBT4CBT With Spanish Alcohol Users

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