Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
Study NCT ID:
NCT06502756
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2024-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Use: A Pilot Study in South Korea
Sponsor:
Yonsei University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BT210029 | OTHER_GRANT | Seoul Metropolitan Government, South Korea | View |