Digital Interventions to Treat Hazardous Drinking

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04890652
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
40
1
1
22.6
1.8

Study Details

Study Description

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 study the impact of COVID-19 related stress on increasing risk of alcohol misuse and relapse in risky social drinkers after digital interventions.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: 4-week intervention
N/A

Detailed Description

This project aims to study the influence of COVID-19 related stress on increasing risk of alcohol misuse and relapse after digital interventions. This project proposes a digital intervention study using a prospective clinical outcome design with two demographically-matched groups of risky social drinkers (total N=40; equal gender ratio) with high versus low COVID-19 related stress. We will utilize a digital intervention method that combines telehealth- and smartphone app- based interventions, allowing concurrent treatment and daily monitoring in a real-life setting. All participants will receive a 4-week telehealth intervention (two sessions per week) using an intervention that integrates alcohol treatment and breathing-based stress reduction methods. Then, they will be prospectively followed for 30 days to monitor stress, alcohol use, social functioning, and other health-related behaviors via a smartphone app.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants will receive a 4-week telehealth intervention involving alcohol treatment and breathing-based stress management. The effects of digital intervention will be assessed before and after the digital intervention.All participants will receive a 4-week telehealth intervention involving alcohol treatment and breathing-based stress management. The effects of digital intervention will be assessed before and after the digital intervention.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Digital Interventions to Treat Hazardous Drinking
Actual Study Start Date :
Oct 13, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Risky drinkers

All participants will receive the same 4 week intervention.

Behavioral: 4-week intervention
All participants will receive a digital intervention to reduce drinking for 4 weeks. There will be two therapy sessions each week using alcohol treatment combined with breathing-based stress management.

Outcome Measures

Primary Outcome Measures

  1. Change in alcohol use (quantity) [baseline, after intervention (up to 30 days)]

    The average amount of alcohol use before and after intervention

  2. Change in alcohol use (frequency) [baseline, after intervention (up to 30 days)]

    Percent drinking days during the 30 day period before and after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale University New Haven Connecticut United States 06492

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Dongju Seo, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT04890652
Other Study ID Numbers:
  • 2000026333
  • R01AA026844-02S1
First Posted:
May 18, 2021
Last Update Posted:
Nov 2, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yale University

Study Results

No Results Posted as of Nov 2, 2021