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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA029400-01 | 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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The purpose of this trial is to test new programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The program sessions focus on getting to know what's important to the participants, reviewing or setting goals, and using different skills and behaviors to better manage health. The trial will help the study team learn about ways to deliver health information in a way that is useful and interesting.
This research will take place remotely (e.g., Zoom, Facetime, Phone) and participants will be randomized to the Telehealth (TeleTx) group intervention or the Enhanced Usual Care (EUC) control group. Both groups will be asked to have follow-up visits up to 12 months from the baseline visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TeleTx intervention | Experimental | The evidence-based manualized psychosocial program is via telehealth and uses adaptations of cognitive behavioral therapy and motivational interviewing. |
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| Enhanced Usual Care (EUC) | Active Comparator | EUC will include brief psychoeducation about AUD and resources for treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Usual Care (EUC) | Behavioral | EUC will comprise one session of brief psychoeducation and referral information to alcohol use disorder (AUD) treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use Disorder Treatment Initiation | Percent of patients who initiate Alcohol Use Disorder psychotherapy treatment | 3 months |
| Alcohol Use Disorder Treatment Engagement | Percent of patients who attend at least 2 additional Alcohol Use Disorder psychotherapy sessions | 3 months |
| Alcohol consumption days | Percent days of alcohol use on the Timeline Follow Back interview | 3-months |
| Alcohol consumption days | Percent days of alcohol use on the Timeline Follow Back interview | 6-months |
| Alcohol consumption days | Percent days of alcohol use on the Timeline Follow Back interview | 12-months |
| Heavy drinking days | Percent days heavy drinking on the Timeline Follow Back interview | 3-months |
| Heavy drinking days | Percent days heavy drinking on the Timeline Follow Back interview | 6-months |
| Heavy drinking days | Percent days heavy drinking on the Timeline Follow Back interview | 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Alcohol Use Disorder Psychotherapy Treatment Attendance | Total number of psychotherapy sessions | 6-months |
| Total Alcohol Use Disorder Psychotherapy Treatment Attendance | Total number of psychotherapy sessions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison Lin, MD | University of Michigan | Principal Investigator |
| Erin Bonar, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Health Care | Veterans Affairs | Ann Arbor | Michigan | 48105 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38679140 | Derived | Bonar EE, Goldstick JE, Rostker MJ, Dailey SE, Augustiniak AN, Brin C, Manderachia DA, Bourque C, Girard R, Sulkowski L, Lin LA. Testing a new model of telehealth-delivered treatment for primary care patients with alcohol use disorder: A randomized controlled trial protocol. Contemp Clin Trials. 2024 Jul;142:107549. doi: 10.1016/j.cct.2024.107549. Epub 2024 Apr 26. |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| TeleTx intervention | Behavioral | TeleTx will consist of an initial session and then 8 ~counseling sessions. |
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| 12-months |
| Drinking Risk Levels (Based on World Health Organization Cut-Offs) | Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes) | Baseline to 3-months |
| Drinking Risk Levels (Based on World Health Organization Cut-Offs) | Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes) | Baseline to 6-months |
| Drinking Risk Levels (Based on World Health Organization Cut-Offs) | Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes) | Baseline to 12-months |
| World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF) | Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life. | Baseline to 3-months |
| World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF) | Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life. | Baseline to 6-months |
| World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF) | Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life. | Baseline to 12-months |
| Alcohol consequences | Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R | Baseline to 3-months |
| Alcohol consequences | Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R | Baseline to 6-months |
| Alcohol consequences | Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R | Baseline to 12-months |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |