Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder

Study Overview
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Brief Summary
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The investigators propose to develop and adapt 'ANZEILAX' smartphone app specifically for individuals with Generalized anxiety disorder. The study will measure the therapeutic effects and safety of 'ANZEILAX' on symptoms of anxiety using pre- and post-treatment scores for generalized anxiety disorder and other physical, emotional, and cognitive symptoms of anxiety

Official Title
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A Single Blind, Parallel Arm, Single Institution Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Device: Software as a Medical device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People can participate in this clinical trial only if following criteria are met. Adults aged 19 years or older with a high school diploma or higher Disease groups according to the criteria below: A person diagnosed with Generalized Anxiety Disorder (DSM-5 (ICD-10) code: 300.02 (F41.1)) Those who are classified as moderate or severe with 10 points or more through GAD-7 Those taking prescription drugs related to generalized anxiety disorder A group of disorders with generalized anxiety disorder, or a group of disorders with worry that is a major symptom of generalized anxiety disorder in any of the following criteria: Those suffering from other anxiety disorders such as panic disorder and social anxiety disorder Those suffering from major depressive disorder accompanied by worry, the main symptom of generalized anxiety disorder A person who fully understands the purpose, contents, and process of the clinical trial, agrees to participate, and signs the consent form in handwriting Exclusion Criteria: If any of the following criteria is applicable, the person cannot participate in this clinical trial. Those who cannot read the consent form Those who are inexperienced in using smartphones In case of psychiatric symptoms or history (including schizophrenia, psychosis, bipolar disorder, epilepsy) In case of brain damage, cognitive impairment, or neurological disease In case of intellectual disability Having a substance and alcohol use disorder Suicidal intent, suicidal ideation, or self-injurious behavior in the past 6 months Receiving cognitive behavioral therapy for anxiety, depression or mood disorders, or participating in such therapy in the past 3 months Those who are registered in other clinical studies Other investigators judged that the conduct of this clinical trial was inappropriate

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The general treatment of the standard treatment method and the test device that provides self-talk training based on acceptance and commitment therapy (ACT) are used concurrently for 10 weeks. | Device: Software as a Medical device<br>* The test device is a software medical device designed for the purpose of treating generalized anxiety disorder that provides self-talk training based on acceptance and commitment therapy (ACT). Use 2 sets per day for 10 weeks with generalized treatment of standard treatment method.<br>* Other names: ANZEILAX;|
| No Intervention: Control Group<br>Treatment as usual (TAU) is a standard treatment for 10 weeks, which is the clinical trial period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder-7 |  | Baseline assessment, Week 5, Week 10, Week 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Anxiety Inventory |  | Baseline assessment, Week 5, Week 10, Week 15 | 
| Penn State Worry Questionnaire |  | Baseline assessment, Week 5, Week 10, Week 15 | 
| Hospital Anxiety and Depression Scale |  | Baseline assessment, Week 5, Week 10, Week 15 | 
| Treatment adherence |  | Week 5, Week 10 | 
| Satisfaction evaluation |  | Week 5, Week 10 |