Substance Use Disorders Clinical Trial
Official title:
Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | February 28, 2026 |
Est. primary completion date | February 28, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Current Diagnostic and Statistical Manual (DSM) -5 alcohol use disorder (AUD) based on alcohol symptom checklist - An average of 3 or more drinking days per week for the past 30 days - Have regular access to a device with video capabilities or a phone to use for study related calls Exclusion Criteria: - Inability to speak or understand English - Conditions that preclude informed consent or understanding of assessment or intervention content - Past 90-day AUD psychotherapy treatment, - At elevated risk for complicated alcohol withdrawal - Past-year drug injection. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | VA Ann Arbor Health Care | Veterans Affairs | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alcohol Use Disorder Treatment Initiation | Percent of patients who initiate Alcohol Use Disorder psychotherapy treatment | 3 months | |
Primary | Alcohol Use Disorder Treatment Engagement | Percent of patients who attend at least 2 additional Alcohol Use Disorder psychotherapy sessions | 3 months | |
Primary | Alcohol consumption days | Percent days of alcohol use on the Timeline Follow Back interview | 3-months | |
Primary | Alcohol consumption days | Percent days of alcohol use on the Timeline Follow Back interview | 6-months | |
Primary | Alcohol consumption days | Percent days of alcohol use on the Timeline Follow Back interview | 12-months | |
Primary | Heavy drinking days | Percent days heavy drinking on the Timeline Follow Back interview | 3-months | |
Primary | Heavy drinking days | Percent days heavy drinking on the Timeline Follow Back interview | 6-months | |
Primary | Heavy drinking days | Percent days heavy drinking on the Timeline Follow Back interview | 12-months | |
Secondary | Total Alcohol Use Disorder Psychotherapy Treatment Attendance | Total number of psychotherapy sessions | 6-months | |
Secondary | Total Alcohol Use Disorder Psychotherapy Treatment Attendance | Total number of psychotherapy sessions | 12-months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Alcohol consequences | Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R | Baseline to 3-months | |
Secondary | Alcohol consequences | Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R | Baseline to 6-months | |
Secondary | Alcohol consequences | Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R | Baseline to 12-months |
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