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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04890652
Other study ID # 2000026333
Secondary ID R01AA026844-02S1
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2021
Est. completion date August 23, 2023

Study information

Verified date February 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date August 23, 2023
Est. primary completion date August 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Yale University New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in alcohol use (quantity) The average amount of alcohol consumption before and after the intervention baseline, after intervention (up to 30 days)
Primary Change in alcohol use (frequency) Percent drinking days before and after intervention baseline, after intervention (up to 30 days)
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