Digital Interventions to Treat Hazardous Drinking

Stress Clinical Trial

Official title:

Digital Interventions to Treat Hazardous Drinking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04890652
• Other study ID #: 2000026333
• Secondary ID: R01AA026844-02S1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hazardous Drinking
• Stress

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)