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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA026815-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Medical University of South Carolina | OTHER |
| Syracuse University | OTHER |
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A small percentage of individuals with alcohol use disorder (AUD) obtain alcohol-related care despite research showing that treatment is effective. This randomized controlled trial tests the efficacy of a brief, phone based cognitive behavioral intervention to increase treatment engagement, improve alcohol related outcomes, and show that treatment engagement is a mechanism for the improved outcomes in individuals with AUD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT Phone Intervention | Experimental | Cognitive-Behavioral Therapy for Treatment Seeking, CBT-TS, a manualized behavioral intervention, administered by telephone in a single session. |
|
| Being Read A Pamphlet on Alcohol Treatment | Active Comparator | Guided review of a National Institute on Alcohol Abuse and Alcoholism (NIAAA) pamphlet on AUD treatment, administered by telephone in a single session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT by Phone to Promote Treatment | Behavioral | Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Drinks Per Drinking Day | Average number of standard drinks on days of alcohol consumption at 3-month follow-up | prior 30 days (at 3-month follow-up) |
| Days Abstinent | Number of days abstinent from alcohol use in prior 30 days | prior 30 days (at 3-month follow-up) |
| Number Initiating Alcohol Use Disorder Treatment | Number Attending any Alcohol Use Disorder Treatment Session(s) over 3-month follow-up | over 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT Phone Intervention | CBT by Phone to Promote Treatment: Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles. |
| FG001 | Being Read A Pamphlet on Alcohol Treatment | Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment: The pamphlet was created by the National Institute on Alcohol Abuse and Alcoholism to describe evidence based treatments available for alcohol use disorder and how to obtain such treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT Phone Intervention | CBT by Phone to Promote Treatment: Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles. |
| BG001 | Being Read A Pamphlet on Alcohol Treatment |
| 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 | Average Drinks Per Drinking Day | Average number of standard drinks on days of alcohol consumption at 3-month follow-up | Posted | Mean | Standard Deviation | drinks per occasion | prior 30 days (at 3-month follow-up) |
|
6 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 | CBT Phone Intervention | CBT by Phone to Promote Treatment: Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute alcohol withdrawal | Psychiatric disorders | Non-systematic Assessment | Acute alcohol withdrawal requiring alcohol detoxification |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth R. Conner | University of Rochester | 585-275-1211 | kenneth_conner@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2022 | Jul 13, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 2, 2018 | Jul 13, 2023 | SAP_001.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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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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The University of Rochester based study team, led by MPI Conner, were masked to treatment assignment (which was performed at the Medical University of South Carolina), and the University of Rochester based team performed all follow-up assessments.
| Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment | Other | The pamphlet was created by the National Institute on Alcohol Abuse and Alcoholism to describe evidence based treatments available for alcohol use disorder and how to obtain such treatment. |
|
Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment: The pamphlet was created by the National Institute on Alcohol Abuse and Alcoholism to describe evidence based treatments available for alcohol use disorder and how to obtain such treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Average Drinks Per Drinking Day (in past 30 days) | Mean | Standard Deviation | standard drinks |
|
| Days Abstinent (in past 30 days) | Mean | Standard Deviation | days (scale 0-30) |
|
| Number Initiating Alcohol Use Disorder Treatment | Count of Participants | Participants |
|
|
|
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| Primary | Days Abstinent | Number of days abstinent from alcohol use in prior 30 days | Posted | Mean | Standard Deviation | Days abstinent (in past 30 days) | prior 30 days (at 3-month follow-up) |
|
|
|
|
| Primary | Number Initiating Alcohol Use Disorder Treatment | Number Attending any Alcohol Use Disorder Treatment Session(s) over 3-month follow-up | Posted | Count of Participants | Participants | over 3 months |
|
|
|
|
| 0 |
| 197 |
| 0 |
| 197 |
| 0 |
| 197 |
| EG001 | Being Read A Pamphlet on Alcohol Treatment | Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment: The pamphlet was created by the National Institute on Alcohol Abuse and Alcoholism to describe evidence based treatments available for alcohol use disorder and how to obtain such treatment. | 0 | 203 | 0 | 203 | 1 | 203 |
|
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