Trial Outcomes & Findings for Digital Interventions to Treat Hazardous Drinking (NCT NCT04890652)
NCT ID: NCT04890652
Last Updated: 2024-09-19
Results Overview
The average number of alcoholic beverages consumed per week (drinks per week), as measured by the Timeline Follow Back.
COMPLETED
NA
33 participants
baseline, immediately post-intervention, and follow-up (30 days)
2024-09-19
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
27
|
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Overall Study
COMPLETED
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25
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Digital Interventions to Treat Hazardous Drinking
Baseline characteristics by cohort
| Measure |
Digital Intervention (4-week)
n=27 Participants
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.
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|---|---|
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Age, Continuous
|
34.9 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
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20 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
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Region of Enrollment
United States
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27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, immediately post-intervention, and follow-up (30 days)Population: 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).
The average number of alcoholic beverages consumed per week (drinks per week), as measured by the Timeline Follow Back.
Outcome measures
| Measure |
Digital Intervention
n=27 Participants
Participants received a 4-week digital intervention, "Emotion regulation via Breathing for Alcohol Reduction (EBA)." Alcohol use outcomes were 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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|---|---|
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Change in Alcohol Use (Quantity)
Baseline
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15.4 drinks per week
Standard Deviation 13.0
|
|
Change in Alcohol Use (Quantity)
Immediately Post-intervention
|
8.5 drinks per week
Standard Deviation 8.1
|
|
Change in Alcohol Use (Quantity)
30 day follow up
|
7.5 drinks per week
Standard Deviation 7.8
|
PRIMARY outcome
Timeframe: baseline, immediately post-intervention, follow-up (30 days)Population: 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).
The number of drinking days per week, as measured by the Timeline Follow Back.
Outcome measures
| Measure |
Digital Intervention
n=27 Participants
Participants received a 4-week digital intervention, "Emotion regulation via Breathing for Alcohol Reduction (EBA)." Alcohol use outcomes were 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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|---|---|
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Change in Alcohol Use (Frequency)
baseline
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4.5 drinking days per week
Standard Deviation 2.2
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Change in Alcohol Use (Frequency)
immediately post-intervention
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2.9 drinking days per week
Standard Deviation 1.9
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Change in Alcohol Use (Frequency)
30 day follow-up
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2.7 drinking days per week
Standard Deviation 2.3
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Adverse Events
Digital Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Digital Intervention
n=27 participants at risk
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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|---|---|
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Infections and infestations
General disorders and administration site conditions - Other, specify
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3.7%
1/27 • Number of events 1 • 2.5 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.7%
1/27 • Number of events 1 • 2.5 months
|
|
Nervous system disorders
General disorders and administration site conditions - Other, specify
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3.7%
1/27 • Number of events 1 • 2.5 months
|
Additional Information
Dongju Seo, Associate Professor
Department of Psychiatry, Yale University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place