Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06502756
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
Evaluating a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Use A Pilot Study in South Korea
Sponsor:
None
Organization:
None
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:
No
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 apps lessons
Acceptability Participants39 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 apps lessons
Acceptability Participants39 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None