Status:
COMPLETED
Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder
Lead Sponsor:
HAII corp.ltd
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
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 'A...
Detailed Description
Purpose: This study is designed to evaluate the safety and efficacy of ANZEILAX, a digital therapeutic intervention delivered via a smartphone application. The application incorporates Acceptance and ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2024
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06010654
Start Date
August 14 2023
End Date
July 24 2024
Last Update
September 19 2024
Active Locations (1)
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1
Yonsei University Health System, Gangnam Severance Hospital
Seoul, South Korea, 06273