- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04890652
Digital Interventions to Treat Hazardous Drinking
February 15, 2024 updated by: Yale University
There has been a significant increase in the prevalence of stress- and alcohol- related disorders during the COVID-19 pandemic.
This project aims to conduct a feasibility study and examine the impact of stress including COVID-19 related stress on increasing risk of alcohol misuse and intervention outcome in risky social drinkers after a digital intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This project proposes a feasibility study to address stress-related drinking using a digital intervention in risky drinkers with emotional stress.
This digital intervention combines telehealth- and smartphone app- based interventions, allowing concurrent intervention and participant-initiated daily exercise in a real-life setting.
This program integrates alcohol intervention with breathing-based stress reduction (two sessions per week) and focuses on the development of emotion regulation skills to help regulate stress, craving, and alcohol misuse.
After the 4-week intervention, all participants will be prospectively followed for 30 days to monitor stress, alcohol use, and other health-related behaviors.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dongju Seo
- Phone Number: 475-202-9849
- Email: dongju.seo@yale.edu
Study Locations
-
-
Connecticut
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New Haven, Connecticut, United States, 06492
- Yale University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Heavy or binge drinkers
- Either high or low COVID-19 related stress
Exclusion Criteria:
- Current or past substance use disorder other than mild alcohol, tobacco, marijuana use disorder
- Psychiatric disorders except for mood and anxiety disorders
- Any significant current medical conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Risky drinkers
All participants will receive the same 4 week intervention.
|
All participants will receive a digital intervention to reduce drinking for 4 weeks.
There will be two sessions each week using an alcohol intervention combined with breathing-based stress management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in alcohol use (frequency)
Time Frame: baseline, after intervention (up to 30 days)
|
Percent drinking days before and after intervention
|
baseline, after intervention (up to 30 days)
|
Change in alcohol use (quantity)
Time Frame: baseline, after intervention (up to 30 days)
|
The average amount of alcohol consumption before and after the intervention
|
baseline, after intervention (up to 30 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dongju Seo, PhD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2021
Primary Completion (Actual)
August 23, 2023
Study Completion (Actual)
August 23, 2023
Study Registration Dates
First Submitted
May 12, 2021
First Submitted That Met QC Criteria
May 12, 2021
First Posted (Actual)
May 18, 2021
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 15, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2000026333
- R01AA026844-02S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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