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

Primary Purpose

Generalized Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Software as a Medical device
Sponsored by
HAII corp.ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Generalized Anxiety Disorder-7

Secondary Outcome Measures

Beck Anxiety Inventory
Penn State Worry Questionnaire
Hospital Anxiety and Depression Scale
Treatment adherence
Satisfaction evaluation

Full Information

First Posted
August 20, 2023
Last Updated
August 20, 2023
Sponsor
HAII corp.ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06010654
Brief Title
Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
April 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HAII corp.ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Treatment as usual (TAU) is a standard treatment for 10 weeks, which is the clinical trial period.
Intervention Type
Device
Intervention Name(s)
Software as a Medical device
Other Intervention Name(s)
ANZEILAX
Intervention Description
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.
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder-7
Time Frame
Baseline assessment, Week 5, Week 10, Week 15
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory
Time Frame
Baseline assessment, Week 5, Week 10, Week 15
Title
Penn State Worry Questionnaire
Time Frame
Baseline assessment, Week 5, Week 10, Week 15
Title
Hospital Anxiety and Depression Scale
Time Frame
Baseline assessment, Week 5, Week 10, Week 15
Title
Treatment adherence
Time Frame
Week 5, Week 10
Title
Satisfaction evaluation
Time Frame
Week 5, Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Yonsei University Health System, Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KIM
Phone
+820220193341
Email
jaejkim@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

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

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