Clinical trial NCT06502756: Evaluating a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Use: A Pilot Study in South Korea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 17
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: uncontrolled, single-arm, pilot study
Primary purpose: PREVENTION

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\&#39; 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Study completion rate
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Adherence rate
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Preliminary Effectiveness
timeFrame: asked at baseline (V1), two weeks (V2), and four weeks (V3).
measure: Acceptability
timeFrame: In the end of treatment at 4 weeks
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
measure: Alcohol Use Disorders Identification Test (AUDIT) Score
timeFrame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
measure: Generalized Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
measure: Perceived Stress Scale (PSS)
timeFrame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
measure: Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)
timeFrame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Department of Psychiatry, Yonsei University College of Medicine Severance Hospital, Yonsei University Health System
name: Young-Chul Jung, Professor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: