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Completed

NCT Number: NCT04890652

Digital Interventions to Treat Hazardous Drinking

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 to evaluate the preliminary efficacy of a digital intervention designed to reduce stress and alcohol use. Additionally, this study will examine the impact of stress, including COVID-19 related stress, on the risk of alcohol misuse and the outcomes of the intervention in risky social drinkers.

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Key information

Conditions

Hazardous Drinking COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06492, United States

About this study

This project proposes a feasibility study to evaluate the preliminary efficacy of a digital intervention aimed at addressing stress-related drinking in risky drinkers with emotional stress. This digital intervention combines telehealth- and smartphone app- based approaches, allowing concurrent intervention and participant-initiated daily exercise in a real-life setting. This program integrates alcohol intervention with breathing-based stress reduction and focuses on developing emotion regulation skills to manage 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Intervention

Behavioral

All participants will receive a digital intervention designed to reduce stress and alcohol consumption over a 4-week period. The intervention will include two weekly sessions that integrate alcohol intervention with breathing-based stress management techniques.

Primary outcomes

  1. Change in Alcohol Use (Quantity)

    Time frame: 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.

  2. Change in Alcohol Use (Frequency)

    Time frame: baseline, immediately post-intervention, follow-up (30 days)

    The number of drinking days per week, as measured by the Timeline Follow Back.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 18, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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