Hazardous Drinking, Stress
Conditions
Keywords
Hazardous drinking, COVID-19, Stress, Digital intervention
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.
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.
Interventions
BEHAVIORALDigital intervention
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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Use (Quantity) | 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) | baseline, immediately post-intervention, follow-up (30 days) | The number of drinking days per week, as measured by the Timeline Follow Back. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Digital Intervention (4-week) |
|---|---|
| Age, Continuous | 34.9 years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 3 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Change in Alcohol Use (Frequency)
The number of drinking days per week, as measured by the Timeline Follow Back.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Digital Intervention | Change in Alcohol Use (Frequency) | baseline | 4.5 drinking days per week | Standard Deviation 2.2 |
| Digital Intervention | Change in Alcohol Use (Frequency) | immediately post-intervention | 2.9 drinking days per week | Standard Deviation 1.9 |
| Digital Intervention | Change in Alcohol Use (Frequency) | 30 day follow-up | 2.7 drinking days per week | Standard Deviation 2.3 |
p-value: <0.001General Linear Model
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Digital Intervention | Change in Alcohol Use (Quantity) | Baseline | 15.4 drinks per week | Standard Deviation 13 |
| Digital Intervention | Change in Alcohol Use (Quantity) | Immediately Post-intervention | 8.5 drinks per week | Standard Deviation 8.1 |
| Digital Intervention | Change in Alcohol Use (Quantity) | 30 day follow up | 7.5 drinks per week | Standard Deviation 7.8 |
p-value: <0.001General Linear Model