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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA024122-01A1 | U.S. NIH Grant/Contract | View source | |
| 1K02AA027300-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment for reducing alcohol use
Evaluate the efficacy of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) and clinician-delivered Cognitive Behavioral Therapy (CBT) relative to standard treatment for reducing alcohol use through an 8-week randomized trial with 6-month follow-up. Our primary hypothesis is that either form of CBT will be more effective than standard treatment at increasing the percentage of days abstinent during treatment (8 weeks) and through the follow-up (6 months), assessed via Timeline FollowBack interviews.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment as usual (TAU) | No Intervention | This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or 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 participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. | |
| Individual clinician-provided CBT | Active Comparator | This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. |
|
| CBT4CBT | Experimental | 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. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual clinician-provided CBT | Behavioral | Individual clinician-provided CBT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back | The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure alcohol use over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use. | Baseline up to 8 weeks |
| Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure change over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use summarized monthly. | from end of treatment at week 8 up to 6 months |
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Inclusion Criteria:
Individuals will be included who:
Exclusion Criteria:
Individuals will be excluded who:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Kiluk, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MCCA | Bridgeport | Connecticut | 06604 | United States | ||
| SATU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39325452 | Derived | Kiluk BD, Benitez B, DeVito EE, Frankforter TL, LaPaglia DM, O'Malley SS, Nich C. A Digital Cognitive Behavioral Therapy Program for Adults With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2435205. doi: 10.1001/jamanetworkopen.2024.35205. |
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Initiated is the number that attended at least 1 treatment session. Every attempt was made to get post treatment and follow up interviews on everyone randomized, regardless of how much of the active treatment the participant received.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment as Usual (TAU) | This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or 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 participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. |
| FG001 | Individual Clinician-provided Cognitive Behavioral Therapy (CBT) | This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. Individual clinician-provided CBT: Individual clinician-provided CBT |
| FG002 | Computer Based Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) | 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. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. CBT4CBT: CBT computer program assisted therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants randomized to a treatment Assignment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment as Usual (TAU) | This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or 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 participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. |
| 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 | Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back | The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure alcohol use over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use. | Intention to treat analysis | Posted | Mean | Standard Deviation | percentage of days abstinent | Baseline up to 8 weeks |
|
Up to 8 months
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| 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 as Usual (TAU) | This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or 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 participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Alcohol Use symptoms | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Kiluk, Associate Professor of Psychiatry | Yale University School of Medicine | 203-737-1544 | Brian.kiluk@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2021 | Dec 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| CBT4CBT | Behavioral | CBT computer program assisted therapy |
|
| New Haven |
| Connecticut |
| 06511 |
| United States |
| Death |
|
| BG001 | Individual Clinician-provided CBT | This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. Individual clinician-provided CBT: Individual clinician-provided CBT |
| BG002 | CBT4CBT | 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. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. CBT4CBT: CBT computer program assisted therapy |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Completed High School | Count of Participants | Participants |
|
| never married/living alone | Count of Participants | Participants |
|
| Unemployed | Count of Participants | Participants |
|
| Lifetime anxiety disorder | Count of Participants | Participants |
|
| Lifetime major depression | Count of Participants | Participants |
|
| AUD Severity Rating | Alcohol Use Disorder (AUD) Severity Rating is a standardized scale from the Structured Clinical Interview Diagnosis (SCID) that assess Alcohol Use Disorder based on the DSM -V criteria. The scale ranges from (0-3 ) 0= absent, 1=Mild, 2 = Moderate, 3 = Severe | Count of Participants | Participants |
|
| Audit Score 16 or higher | The Alcohol Use Disorders Identification Test (AUDIT) is a 10 item questionnaire. The Range of the score is (0 - 40) with higher scores meaning more severe alcohol use disorder. The cut off score of 16 was used to create a dichotomous variable with the value of 0 = No, (AUDIT score less than 16) and 1= Yes,( AUDIT Score is 16 or higher) | Count of Participants | Participants |
|
| On probation/ court referred | Count of Participants | Participants |
|
| Mean days of alcohol use during the past 28 days | Mean | Standard Deviation | days |
|
| Mean days of heavy drinking during the past 28 days | Heavy drinking is considered 4 or more drinks for a women in a 24 hour period and 5 or more drinks for men in a 24 hour period | Mean | Standard Deviation | days |
|
| Mean number of Drinks per drinking day during the past 28 days | The average number of drinks a person consumed on a day that they drank alcohol | Mean | Standard Deviation | drinks per drinking day |
|
| Mean number of Years of regular alcohol use | number of years of alcohol use where the frequency was 3 or more times per week | Mean | Standard Deviation | years |
|
| Audit Score | The Alcohol Use Disorders Identification Test (AUDIT) is a 10 item questionnaire. The Range of the total score is (0 - 40) with higher scores meaning more severe alcohol use disorder. | Mean | Standard Deviation | units on a scale |
|
| pre-treatment SCID Alcohol Symptom Count | Mean | Standard Deviation | symptoms |
|
| OG001 | Individual Clinician-provided CBT | This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. Individual clinician-provided CBT: Individual clinician-provided CBT |
| OG002 | CBT4CBT | 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. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. CBT4CBT: CBT computer program assisted therapy |
|
|
|
| Primary | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure change over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use summarized monthly. | Intention to treat process was used for data collection. All randomized participants were tracked and follow up data collection was attempted for the 6 months post treatment. Contact attempts were at 1 month, 3 month and 6 month post treatment. Analysis population numbers start at the number of randomized participants that completed the 1 month post treatment interview. Months 2 and 3 numbers reflex number of randomized participants that attended the 3 month post treatment interview and so on. | Posted | Mean | Standard Deviation | percentage of days abstinent | from end of treatment at week 8 up to 6 months |
|
|
|
|
| 1 |
| 34 |
| 8 |
| 34 |
| 0 |
| 34 |
| EG001 | Individual Clinician-provided CBT | This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. Individual clinician-provided CBT: Individual clinician-provided CBT | 0 | 32 | 1 | 32 | 0 | 32 |
| EG002 | CBT4CBT | 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. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. CBT4CBT: CBT computer program assisted therapy | 0 | 33 | 7 | 33 | 0 | 33 |
| Hospitalization for Detox | Psychiatric disorders | Systematic Assessment |
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| Hospitalization for Mental health | Psychiatric disorders | Systematic Assessment |
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| Hospitalization for Lacerations to body | General disorders | Systematic Assessment |
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| Hospitalization for Intestinal issue | Gastrointestinal disorders | Systematic Assessment |
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| Follow Up Month 1 |
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| Follow Up Month 2 |
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| Follow Up Month 3 |
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| Follow Up Month 4 |
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| Follow Up Month 5 |
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| Follow Up Month 6 |
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