Digital Interventions to Treat Hazardous Drinking

NCT04890652 | Completed Results

• 2 other identifiers: 2000026333R01AA026844-02S1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hazardous Drinking; Stress

Keywords

Hazardous drinking; COVID-19; Stress; Digital intervention

Outcome Measures

Primary Outcomes (2)

• Change in Alcohol Use (Quantity)

  The average number of alcoholic beverages consumed per week (drinks per week), as measured by the Timeline Follow Back.

  baseline, immediately post-intervention, and follow-up (30 days)

• Change in Alcohol Use (Frequency)

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

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

Study Arms (1)

Risky drinkers

OTHER

All participants will receive the same 4-week intervention program.

Behavioral: Digital intervention

Interventions

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.

Risky drinkers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06492, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dongju Seo, Associate Professor
• Organization: Department of Psychiatry, Yale University School of Medicine

dongju.seo@yale.edu

475-441-3457

Study Officials

• Dongju Seo, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants received a 4-week digital intervention, "Emotion regulation via Breathing for Alcohol reduction (EBA)," which combines alcohol intervention with stress reduction techniques based on self-regulated breathing exercises. The preliminary efficacy of this digital intervention was evaluated through assessments conducted before and immediately after the intervention, as well as during a follow-up assessment 30 days later.

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: October 13, 2021
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)