Hazardous DrinkingNCT04890652
Digital Interventions to Treat Hazardous Drinking
A study testing Digital intervention in people with Hazardous Drinking and Stress, run by Yale University at 1 site in United States.
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 to evaluate the preliminary efficacy of a digital intervention designed to reduce stress and alcohol use. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hazardous Drinking, Stress
- What is being tested?
- Digital intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2021to 23 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Heavy or binge drinkers
- Either high or low COVID-19 related stress
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Hazardous Drinking, Stress
- Being tested
- Digital intervention
- Keywords
- Hazardous drinking, COVID-19, Stress, Digital intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Risky drinkers | Other | All participants will receive the same 4-week intervention program. Receives: Behavioral: Digital intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Use (Quantity)
The average number of alcoholic beverages consumed per week (drinks per week), as measured by the Timeline Follow Back.
Measured: 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.
Measured: baseline, immediately post-intervention, follow-up (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start13 Oct 2021
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hazardous DrinkingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Dongju Seo, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890652
- Sponsor's protocol ID
- 2000026333
- Other IDs
- R01AA026844-02S1
- Status last verified
- Aug 2024
- First submitted
- 12 May 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seo D, Choi JJ, Goldberg LM, Sinha R. Integrating breathing-based stress reduction to address stress and alcohol misuse: A novel digital intervention delivered via telehealth and smartphone application. Alcohol Clin Exp Res (Hoboken). 2025 Sep;49(9):2076-2091. doi: 10.1111/acer.70131. Epub 2025 Aug 9.
PubMed 40781881
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Interventions to Treat Hazardous Drinking
- ClinicalTrials.gov ID
- NCT04890652
- Acronym / sponsor ID
- 2000026333
- Conditions
- Hazardous Drinking, Stress
- Keywords
- Hazardous drinking, COVID-19, Stress, Digital intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Risky drinkers | Other | Behavioral: Digital interventionAll participants will receive the same 4-week intervention program. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Heavy or binge drinkers
- Either high or low COVID-19 related stress
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital interventionAll 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. | Behavioural | Risky drinkers |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40781881Seo D, Choi JJ, Goldberg LM, Sinha R. Integrating breathing-based stress reduction to address stress and alcohol misuse: A novel digital intervention delivered via telehealth and smartphone application. Alcohol Clin Exp Res (Hoboken). 2025 Sep;49(9):2076-2091. doi: 10.1111/acer.70131. Epub 2025 Aug 9.
- Individual participant dataSharing planned: No
Related trials for Hazardous Drinking
Active, not recruiting
Improving Help-seeking Propensity Through a Micro-intervention Targeting Common Concerns Among Individuals With Alcohol Problems: A Randomized Controlled Experiment
Alcohol Abuse, Harmful Alcohol Use
Not yet recruiting
Telephone-Based Acceptance and Commitment Therapy for Young Adult Hazardous Drinkers
Hazardous Drinking, Harmful Alcohol Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongju Seo, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital intervention in people with Hazardous Drinking and Stress, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alcohol Use (Quantity) (time frame: baseline, immediately post-intervention, and follow-up (30 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04890652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 29 Oct 2026.