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

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

Study Overview

• Status: Recruiting
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Device: Software as a Medical device

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06273
    • Recruiting
    • Yonsei University Health System, Gangnam Severance Hospital
    • Contact: KIM; Phone Number: +820220193341; Email: jaejkim@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 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.	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.; Other Names: ANZEILAX
No Intervention: Control Group; Treatment as usual (TAU) is a standard treatment for 10 weeks, which is the clinical trial period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Generalized Anxiety Disorder-7	Baseline assessment, Week 5, Week 10, Week 15

Secondary Outcome Measures

Outcome Measure	Time Frame
Beck Anxiety Inventory	Baseline assessment, Week 5, Week 10, Week 15
Penn State Worry Questionnaire	Baseline assessment, Week 5, Week 10, Week 15
Hospital Anxiety and Depression Scale	Baseline assessment, Week 5, Week 10, Week 15
Treatment adherence	Week 5, Week 10
Satisfaction evaluation	Week 5, Week 10

Collaborators and Investigators

• Sponsor: HAII corp.ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): April 4, 2024

Study Registration Dates

• First Submitted: August 20, 2023
• First Submitted That Met QC Criteria: August 20, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 3-2023-0018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No