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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA026844-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risky drinkers | Other | All participants will receive the same 4-week intervention program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dongju Seo, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06492 | United States |
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Out of the 33 enrolled participants, six participants did not start the study due to scheduling difficulties (N=2), no shows (N=3), and obtaining a new job (N=1).
All participants were recruited starting on October 13, 2021 via online platforms (e.g., craigslist) and flyers. A recruitment center was located in New Haven, Connecticut.
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| ID | Title | Description |
|---|---|---|
| FG000 | Digital Intervention (4-week) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Digital Intervention (4-week) | 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 effects of this digital intervention were evaluated through assessments conducted before and immediately after the intervention, as well as during a follow-up assessment 30 days later. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Alcohol Use (Quantity) | The average number of alcoholic beverages consumed per week (drinks per week), as measured by the Timeline Follow Back. | Two participants (N=2) discontinued participation in the study following the baseline assessment; One participant withdrew during the second week of the intervention due to scheduling difficulties from a personal busy schedule, and the other participant withdrew in week 4 of the intervention due to non-compliance issues (e.g., repeated instances of not showing up). | Posted | Mean | Standard Deviation | drinks per week | baseline, immediately post-intervention, and follow-up (30 days) |
|
2.5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Digital Intervention | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions - Other, specify | Infections and infestations | Infection | Systematic Assessment | One episode of a respiratory infection, unrelated to the intervention, during the second week of the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dongju Seo, Associate Professor | Department of Psychiatry, Yale University School of Medicine | 475-441-3457 | dongju.seo@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 4, 2022 | Jul 23, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2023 | Jul 23, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Change in Alcohol Use (Frequency) | The number of drinking days per week, as measured by the Timeline Follow Back. | Two participants (N=2) discontinued participation in the study following the baseline assessment; One participant withdrew during the second week of the intervention due to scheduling difficulties from a personal busy schedule, and the other participant withdrew in week 4 of the intervention due to non-compliance issues (e.g., repeated instances of not showing up). | Posted | Mean | Standard Deviation | drinking days per week | baseline, immediately post-intervention, follow-up (30 days) |
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| 0 |
| 27 |
| 0 |
| 27 |
| 3 |
| 27 |
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| General disorders and administration site conditions - Other, specify | General disorders | Cold | Systematic Assessment | One episode of cold symptoms, unrelated to the intervention, occurred during the first week of the intervention. |
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| General disorders and administration site conditions - Other, specify | Nervous system disorders | Seizure | Systematic Assessment | One episode of moderate seizure-like symptoms, inherent to the participant and unrelated to the intervention, occurred post-intervention |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 30 day follow-up |
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