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Completed

NCT Number: NCT06502756

Evaluating a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Use: A Pilot Study 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:

* 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.

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Key information

Conditions

High-risk Drinkers Hazardous Alcohol Use

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOBER, mobile Application providing digital CBT

Device

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.

Primary outcomes

  1. 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

  2. Adherence rate

    Time frame: From enrollment to the end of treatment at 4 weeks

    The adherence rate of educational sessions in the application

  3. Preliminary Effectiveness

    Time frame: asked at baseline (V1), two weeks (V2), and four weeks (V3).

    days abstinent (%) in the past two weeks

  4. 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).

Secondary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).

    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.

  2. Alcohol Use Disorders Identification Test (AUDIT) Score

    Time frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).

    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

  3. Generalized Anxiety Disorder 7-item Scale (GAD-7)

    Time frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).

    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.

  4. Perceived Stress Scale (PSS)

    Time frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).

    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

  5. Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)

    Time frame: Administered at baseline (V1), two weeks (V2), and four weeks (V3).

    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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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