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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06010654
Other study ID # 3-2023-0018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 14, 2023
Est. completion date April 4, 2024

Study information

Verified date August 2023
Source HAII corp.ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 'ANZEILAX' on symptoms of anxiety using pre- and post-treatment scores for generalized anxiety disorder and other physical, emotional, and cognitive symptoms of anxiety


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date April 4, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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: 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Software as a Medical device
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.

Locations

Country Name City State
Korea, Republic of Yonsei University Health System, Gangnam Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
HAII corp.ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Generalized Anxiety Disorder-7 Baseline assessment, Week 5, Week 10, Week 15
Secondary Beck Anxiety Inventory Baseline assessment, Week 5, Week 10, Week 15
Secondary Penn State Worry Questionnaire Baseline assessment, Week 5, Week 10, Week 15
Secondary Hospital Anxiety and Depression Scale Baseline assessment, Week 5, Week 10, Week 15
Secondary Treatment adherence Week 5, Week 10
Secondary Satisfaction evaluation Week 5, Week 10
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