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

A Single Blind, Parallel arm, Single Institution Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics ‘ANZEILAX’ for Managing Generalized Anxiety Disorder

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0008476
Enrollment
96
Registered
2023-05-26
Start date
2023-08-14
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Test group: 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 com

Sponsors

Haii
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: People can participate in this clinical trial only if following criteria are met. 1. Adults aged 19 years or older with a high school diploma or higher 2. 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 3. 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 4. 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

Exclusion criteria: If any of the following criteria is applicable, the person cannot participate in this clinical trial. 1. Those who cannot read the consent form 2. Those who are inexperienced in using smartphones 3. In case of psychiatric symptoms or history (including schizophrenia, psychosis, bipolar disorder, epilepsy) 4. In case of brain damage, cognitive impairment, or neurological disease 5. In case of intellectual disability 6. Having a substance and alcohol use disorder 7. Suicidal intent, suicidal ideation, or self-injurious behavior in the past 6 months 8. Receiving cognitive behavioral therapy for anxiety, depression or mood disorders, or participating in such therapy in the past 3 months 9. Those who are registered in other clinical studies 10. Other investigators judged that the conduct of this clinical trial was inappropriate

Design outcomes

Primary

MeasureTime frame
Generalized Anxiety Disorder-7

Secondary

MeasureTime frame
Beck Anxiety Inventory;Penn State Worry Questionnaire;Hospital Anxiety and Depression Scale;Treatment adherence;Satisfaction

Countries

Korea, Republic of

Contacts

Public ContactEunji Kim

Yonsei University Health System, Gangnam Severance Hospital

kej9104@naver.com+82-2-2019-3341

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026