Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AA025605 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
Not provided
Not provided
Not provided
Not provided
Specific aims are as follows:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
|
| 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:
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard treatment (ST) PLUS web-based CBT4CBT | Behavioral | 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 |
| 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, 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Manuel Paris, PsyD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwestern Connecticut Council on Alcoholism (MCCA) | Bridgeport | Connecticut | 06511 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41361015 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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 |
| FG001 | 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:
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. 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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:
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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One participant was lost to follow up beginning week 4 in the Standard treatment (ST) PLUS web-based CBT4CBT. | Posted | Mean | Standard Deviation | percentage of days abstinent per week | By week for 8 weeks |
|
8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment | Hospitalization for Alcohol Use symptoms |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Kiluk, Ph.D. | Yale University Department of Psychiatry | 203-737-1544 | brian.kiluk@yale.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2019 | Jul 10, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2019 | Nov 14, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 12, 2021 | Feb 1, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
Number of individuals with no heavy drinking days in the last 4 weeks of treatment
| last 4 weeks of treatment (4 weeks) |
| Cornell Scott - Hill Health Center |
| New Haven |
| Connecticut |
| 06511 |
| United States |
| Hispanic Clinic of CMHC | New Haven | Connecticut | 06511 | United States |
| Midwestern Connecticut Council on Alcoholism (MCCA) | New Haven | Connecticut | 06511 | United States |
| Multi-Cultural Ambulatory Addiction Services (MAAS) | New Haven | Connecticut | 06511 | United States |
| BG001 | 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:
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. 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Client Origin of birth | Count of Participants | Participants |
|
| Completed High School | Count of Participants | Participants |
|
| Never married/living alone | Count of Participants | Participants |
|
| Unemployed | Count of Participants | Participants |
|
| On parole or probation | Count of Participants | Participants |
|
| Referred by criminal justice system | Count of Participants | Participants |
|
| On Public Assistance | Count of Participants | Participants |
|
| Previous computer experience | Count of Participants | Participants |
|
| Lifetime anxiety disorder | Count of Participants | Participants |
|
| Lifetime major depression | Count of Participants | Participants |
|
| Lifetime PTSD by SCID | Count of Participants | Participants |
|
| Current PTSD by SCID | Count of Participants | Participants |
|
| Current anxiety disorder | Count of Participants | Participants |
|
| Current major depression | Count of Participants | Participants |
|
| Alcohol Use Disorder (AUD) Severity Rating | AUD scale: Mild: The presence of 2 to 3 symptoms, Moderate: The presence of 4 to 5 symptoms, Severe: The presence of 6 or more symptoms. | Count of Participants | Participants |
|
| Diagnosed PTSD by PCL-5 | The PCL-5 is a questionnaire used to assess symptom criteria for PTSD. | Count of Participants | Participants |
|
| Alcohol Use Disorders Identification Test (Audit) Score 16 or higher | Total score range of 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption, scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | Count of Participants | Participants |
|
| Days paid for work in past 28 | Mean | Standard Deviation | days |
|
| Days of alcohol use in the past 28 | Mean | Standard Deviation | days |
|
| Days of heavy alcohol use in the past 28 | Mean | Standard Deviation | days |
|
| Drinks per drinking days in the past 28 | Mean | Standard Deviation | drinks |
|
| Percent days of alcohol abstinence in the past 28 | Mean | Standard Deviation | percentage of days |
|
| Percent days of heavy drinking in the past 28 | Mean | Standard Deviation | percentage of days |
|
| Percent days of alcohol abstinence at week 0 | Mean | Standard Deviation | percentage of days |
|
| Percent days of heavy drinking at week 0 | Mean | Standard Deviation | percentage of days |
|
| Age first used alcohol | Mean | Standard Deviation | years |
|
| Years of alcohol use | Mean | Standard Deviation | years |
|
| Pre-treatment Alcohol Symptom Count | Mean | Standard Deviation | symptom count |
|
| Pre-treatment AUDIT Score | Total score range of 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption, scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | Mean | Standard Deviation | score on a scale |
|
| Years living in United States | Mean | Standard Deviation | years |
|
| OG001 | 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:
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 |
|
|
|
| Primary | 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. | All participants assessed during the period. | Posted | Mean | Standard Deviation | percentage of days abstinent in a month | Months 3 through 8 (6 months total) |
|
|
|
|
| Secondary | Secondary Outcomes Include Percent Heavy Drinking Days | Percent heavy drinking days during 8 weeks of trial | Participants completing the full study. | Posted | Mean | Standard Deviation | percentage of heavy drinking days | 8 weeks |
|
|
|
|
| Secondary | 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 | Participants completing the study. | Posted | Count of Participants | Participants | last 4 weeks of treatment (4 weeks) |
|
|
|
|
| 0 |
| 28 |
| 2 |
| 28 |
| 0 |
| 28 |
| EG001 | 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:
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. 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 | 1 | 23 | 4 | 23 | 0 | 23 |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment | Hospitalization for Detox |
|
| Psychiatric disorders - Other, specify | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment | Hospitalization for Mental health |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE v5.0 | Systematic Assessment | Hospitalization for Infection |
|
| Renal calculi | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment | Hospitalization for Kidney stones |
|
Not provided
Not provided
Not provided
| South American country |
|
| Mexico |
|
| Other Central American country |
|
| Carribean Island |
|
| South American country |
|
| Mexico |
|
| Other Central American country |
|
| Carribean Island |
|
| month 5 |
|
| month 6 |
|
| month 7 |
|
| month 8 |
|