Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder
Generalized Anxiety Disorder
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
Eligibility Criteria
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
Sites / Locations
- Yonsei University Health System, Gangnam Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Experimental Group
Control Group
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.
Treatment as usual (TAU) is a standard treatment for 10 weeks, which is the clinical trial period.