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

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06010654
• Other study ID #: 3-2023-0018
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

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