Digital Interventions to Treat Hazardous Drinking

Not Applicable

Completed

• Conditions: Stress; Hazardous Drinking
• Interventions: Behavioral: Digital intervention

• Registration Number: NCT04890652
• Lead Sponsor: Yale University

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-18
• Study Start: 2021-10-13
• Primary Completion: 2023-08-23
• Study Completion: 2023-08-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Heavy or binge drinkers
• Either high or low COVID-19 related stress

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Risky drinkers	Digital intervention	All participants will receive the same 4-week intervention program.

Primary Outcome Measures

Name	Time	Method
Change in Alcohol Use (Quantity)	baseline, immediately post-intervention, and follow-up (30 days)	The average number of alcoholic beverages consumed per week (drinks per week), as measured by the Timeline Follow Back.
Change in Alcohol Use (Frequency)	baseline, immediately post-intervention, follow-up (30 days)	The number of drinking days per week, as measured by the Timeline Follow Back.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States