High-risk DrinkersNCT06502756
Evaluating a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Use: A Pilot Study in South Korea
A study testing SOBER, mobile Application providing digital CBT in people with High-risk Drinkers and Hazardous Alcohol Use, run by Yonsei University at 1 site in South Korea.
Trial summary
The goal of this single arm pilot study is to investigate the feasibility, acceptability and preliminary effectiveness of the mobile app SOBER; for reducing and preventing hazardous alcohol drinking. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- High-risk Drinkers, Hazardous Alcohol Use
- What is being tested?
- SOBER, mobile Application providing digital CBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2023to 24 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged between 19 and 65 years.
- Individuals classified as high-risk drinkers (hazardous drinking): Alcohol Use Disorder Identification Test (AUDIT) score of 8 or higher
- Individuals who have been admitted for treatment of alcohol use disorder no more than once.
- Individuals who are assessed to have completed detoxification treatment for alcohol.
- Individuals who own a smartphone and can independently use apps on the smartphone.
- Individuals who voluntarily agree to participate in this clinical study and have signed the consent form (or whose representative has signed the consent form).
Who cannot join
- individuals with active and progressive physical illnesses or a life expectancy of less than 6 months
- individuals with major psychiatric comorbidities such as schizophrenia, bipolar disorder, or major depressive disorder
- pregnant women or those planning to become pregnant during the study
- individuals who had participated in another clinical study within four weeks prior to the screening for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development, Feasibility, Acceptability, and Preliminary Effectiveness of a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Drinking: A Single-Arm Pilot Study With Predictive Modeling in South Korea
The goal of this single arm pilot study is to investigate the feasibility, acceptability and preliminary effectiveness of the mobile app SOBER; for reducing and preventing hazardous alcohol drinking.
The main questions it aims to answer are:
Read more
- Feasibility: How well participants adhere to the app's lessons?
- Acceptability: Participants\' satisfaction with and perceived usefulness of the app.
- Preliminary Effectiveness: The number of days participants remain abstinent.
Participants will:
- Use the mobile application SOBER, which delivers digital cognitive behavioral therapy, for four weeks.
- Wear a smartwatch to collect biometric data throughout the study.
- Visit the clinic three times: at baseline (V1), two weeks after the initial visit (V2), and four weeks after the initial visit (V3).
- Be evaluated using various questionnaires about their alcohol consumption, mood, and stress levels at each visit.
- Receive psychiatric consultation with a board-certified psychiatrist regarding their alcohol consumption, based on the data entered into the mobile app.
- Conditions
- High-risk Drinkers, Hazardous Alcohol Use
- Being tested
- SOBER, mobile Application providing digital CBT
- Keywords
- digital intervention, mobile app, high-risk drinkers, hazardous alcohol use, secondary prevention, digital cognitive behavioral therapy, digital health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOBER, mobile Application providing digital CBTDevice
SOBER is a software application (Android) that delivers cognitive behavioral therapy (CBT) in a structured and interactive manner. It analyzes patterns in participants\' lifestyles to identify problematic behaviors related to their alcohol consumption. By providing tailored guidance and support, the app aims to help individuals make sustainable changes, ultimately reducing hazardous drinking. This approach combines the principles of CBT with the convenience and accessibility of digital technology, offering a personalized experience to support the reduction of alcohol consumption.
| Study group | Role | What they receive |
|---|---|---|
| mobile application SOBER (digital cognitive behavioral therapy) | Experimental | Participants in this group will access to the mobile app SOBER for 4 weeks. Sober is designed to provide digitalized brief-intervention and cognitive CBT-based education for high-risk drinkers. Participants are expected to engage with the app, completing tasks such as self-monitoring (daily log function that instructs participants to record their alcohol consumption, along with changes in mood, appetite and sleep quality). The app will collect data on adherence, including diary completion rates and app login frequency. Participants were also provided with a smart watch to collect biometric data throughout the duration of the study. Receives: Device: SOBER, mobile Application providing digital CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study completion rate
The feasibility of the intervention was assessed based on the completion rates of the study
Measured: From enrollment to the end of treatment at 4 weeks
Adherence rate
The adherence rate of educational sessions in the application
Measured: From enrollment to the end of treatment at 4 weeks
Preliminary Effectiveness
days abstinent (%) in the past two weeks
Measured: asked at baseline (V1), two weeks (V2), and four weeks (V3).
Acceptability
assessed through participant satisfaction and perceived usefulness of the app, evaluated using a Likert-scale.
Participants were asked to rate their satisfaction with the app on a scale from 0 (Not satisfied at all) to 5 (Very satisfied); and usefulness of the app from 0 (Not useful at all) to 5 (Very useful).
Measured: In the end of treatment at 4 weeks
Secondary outcomes (5)
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9-item self-administered scale for assessing the severity of depression. Score Range: 0-27. : Higher scores indicate more severe depression. Scores of 10 or above suggest the need for treatment of depression.
Measured: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Alcohol Use Disorders Identification Test (AUDIT) Score
The AUDIT is a 10-item questionnaire designed to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Higher scores indicate more severe alcohol-related issues. A score of 8 or above suggests hazardous or harmful alcohol use. Score Range: 0-40
Measured: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Generalized Anxiety Disorder 7-item Scale (GAD-7)
The GAD-7 is a 7-item self-report scale for identifying probable cases of generalized anxiety disorder and assessing its severity. Score Range: 0-21. Higher scores indicate more severe anxiety. Scores of 10 or above suggest the presence of generalized anxiety disorder.
Measured: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Perceived Stress Scale (PSS)
The PSS is a 10-item questionnaire measuring the perception of stress. Score Range: 0-40. Higher scores indicate higher perceived stress levels. There are no specific cut-off scores; rather, scores indicate the relative level of stress perceived by the individual
Measured: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)
The CIWA-Ar is a 10-item scale used to assess the severity of alcohol withdrawal symptoms. Score Range: 0-67. Higher scores indicate more severe withdrawal symptoms. Scores of 10 or above indicate the need for medical intervention.
Measured: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start26 May 2023
- Primary completion22 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk DrinkersStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- uncontrolled, single-arm, pilot study
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YOUNG-CHUL JUNG, Yonsei University
- Investigators
- Young-Chul Jung, Professor, MD, PhD, Principal investigator, Department of Psychiatry, Yonsei University College of Medicine Severance Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502756
- Sponsor's protocol ID
- WCTP-A-D-1
- Other IDs
- BT210029
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Feasibility, Acceptability, and Preliminary Effectiveness of a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Drinking: A Single-Arm Pilot Study With Predictive Modeling in South Korea
- ClinicalTrials.gov ID
- NCT06502756
- Acronym / sponsor ID
- WCTP-A-D-1
- Conditions
- High-risk Drinkers, Hazardous Alcohol Use
- Keywords
- digital intervention, mobile app, high-risk drinkers, hazardous alcohol use, secondary prevention, digital cognitive behavioral therapy, digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this single arm pilot study is to investigate the feasibility, acceptability and preliminary effectiveness of the mobile app SOBER; for reducing and preventing hazardous alcohol drinking.
The main questions it aims to answer are:
- Feasibility: How well participants adhere to the app's lessons?
- Acceptability: Participants\' satisfaction with and perceived usefulness of the app.
- Preliminary Effectiveness: The number of days participants remain abstinent.
Participants will:
- Use the mobile application SOBER, which delivers digital cognitive behavioral therapy, for four weeks.
- Wear a smartwatch to collect biometric data throughout the study.
- Visit the clinic three times: at baseline (V1), two weeks after the initial visit (V2), and four weeks after the initial visit (V3).
- Be evaluated using various questionnaires about their alcohol consumption, mood, and stress levels at each visit.
- Receive psychiatric consultation with a board-certified psychiatrist regarding their alcohol consumption, based on the data entered into the mobile app.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- uncontrolled, single-arm, pilot study
| Arm | Type | Receives |
|---|---|---|
| mobile application SOBER (digital cognitive behavioral therapy) | Experimental | Device: SOBER, mobile Application providing digital CBTParticipants in this group will access to the mobile app SOBER for 4 weeks. Sober is designed to provide digitalized brief-intervention and cognitive CBT-based education for high-risk drinkers. Participants are expected to engage with the app, completing tasks such as self-monitoring (daily log function that instructs participants to record their alcohol consumption, along with changes in mood, appetite and sleep quality). The app will collect data on adherence, including diary completion rates and app login frequency. Participants were also provided with a smart watch to collect biometric data throughout the duration of the study. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals aged between 19 and 65 years.
- Individuals classified as high-risk drinkers (hazardous drinking): Alcohol Use Disorder Identification Test (AUDIT) score of 8 or higher
- Individuals who have been admitted for treatment of alcohol use disorder no more than once.
- Individuals who are assessed to have completed detoxification treatment for alcohol.
- Individuals who own a smartphone and can independently use apps on the smartphone.
Key exclusion criteria (4 listed)
- individuals with active and progressive physical illnesses or a life expectancy of less than 6 months
- individuals with major psychiatric comorbidities such as schizophrenia, bipolar disorder, or major depressive disorder
- pregnant women or those planning to become pregnant during the study
- individuals who had participated in another clinical study within four weeks prior to the screening for this study
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 |
|---|---|---|
| SOBER, mobile Application providing digital CBTSOBER is a software application (Android) that delivers cognitive behavioral therapy (CBT) in a structured and interactive manner. It analyzes patterns in participants\' lifestyles to identify problematic behaviors related to their alcohol consumption. By providing tailored guidance and support, the app aims to help individuals make sustainable changes, ultimately reducing hazardous drinking. This approach combines the principles of CBT with the convenience and accessibility of digital technology, offering a personalized experience to support the reduction of alcohol consumption. | Device | mobile application SOBER (digital cognitive behavioral therapy) |
Primary outcome
Study completion rate
Time frame: From enrollment to the end of treatment at 4 weeks
The feasibility of the intervention was assessed based on the completion rates of the study
Adherence rate
Time frame: From enrollment to the end of treatment at 4 weeks
The adherence rate of educational sessions in the application
Preliminary Effectiveness
Time frame: asked at baseline (V1), two weeks (V2), and four weeks (V3).
days abstinent (%) in the past two weeks
Acceptability
Time frame: In the end of treatment at 4 weeks
assessed through participant satisfaction and perceived usefulness of the app, evaluated using a Likert-scale. Participants were asked to rate their satisfaction with the app on a scale from 0 (Not satisfied at all) to 5 (Very satisfied); and usefulness of the app from 0 (Not useful at all) to 5 (Very useful).
5 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Alcohol Use Disorders Identification Test (AUDIT) Score
Time frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Perceived Stress Scale (PSS)
Time frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)
Time frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Young-Chul Jung, Professor, MD, PhD principal investigator
Department of Psychiatry, Yonsei University College of Medicine Severance Hospital, Yonsei University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOBER, mobile Application providing digital CBT in people with High-risk Drinkers and Hazardous Alcohol Use, run by Yonsei University at 1 site in South Korea.
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 6 inclusion and 4 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 16 Jul 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Study completion rate (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2024.