Substance Dependence, Substance Use, Substance Use Disorders
Conditions
Keywords
Telehealth, Cognitive behavioral therapy, Psychoeducation, Motivational interviewing, Alcohol consumption
Brief summary
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.
Interventions
BEHAVIORALEnhanced Usual Care (EUC)
EUC will comprise one session of brief psychoeducation and referral information to alcohol use disorder (AUD) treatment.
BEHAVIORALTeleTx intervention
TeleTx will consist of an initial session and then 8 \~counseling sessions.
Sponsors
University of Michigan
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use Disorder Treatment Initiation | 3 months | Percent of patients who initiate Alcohol Use Disorder psychotherapy treatment |
| Alcohol Use Disorder Treatment Engagement | 3 months | Percent of patients who attend at least 2 additional Alcohol Use Disorder psychotherapy sessions |
| Alcohol consumption days | 3-months | Percent days of alcohol use on the Timeline Follow Back interview |
| Heavy drinking days | 3-months | Percent days heavy drinking on the Timeline Follow Back interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Alcohol Use Disorder Psychotherapy Treatment Attendance | 6-months | Total number of psychotherapy sessions |
| Drinking Risk Levels (Based on World Health Organization Cut-Offs) | Baseline to 3-months | Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes) |
| World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF) | Baseline to 3-months | Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life. |
| Alcohol consequences | Baseline to 3-months | Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAllison Lin, MD
University of Michigan
PRINCIPAL_INVESTIGATORErin Bonar, PhD
University of Michigan
Outcome results
None listed