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

Sponsor
HAII corp.ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06010654
Collaborator
(none)
96
Enrollment
1
Location
2
Arms
7.7
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Software as a Medical device
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 14, 2023
Anticipated Primary Completion Date :
Feb 29, 2024
Anticipated Study Completion Date :
Apr 4, 2024

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Generalized Anxiety Disorder-7 [Baseline assessment, Week 5, Week 10, Week 15]

    Secondary Outcome Measures

    1. Beck Anxiety Inventory [Baseline assessment, Week 5, Week 10, Week 15]

    2. Penn State Worry Questionnaire [Baseline assessment, Week 5, Week 10, Week 15]

    3. Hospital Anxiety and Depression Scale [Baseline assessment, Week 5, Week 10, Week 15]

    4. Treatment adherence [Week 5, Week 10]

    5. Satisfaction evaluation [Week 5, Week 10]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. 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

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei University Health System, Gangnam Severance Hospital Seoul Korea, Republic of 06273

    Sponsors and Collaborators

    • HAII corp.ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HAII corp.ltd
    ClinicalTrials.gov Identifier:
    NCT06010654
    Other Study ID Numbers:
    • 3-2023-0018
    First Posted:
    Aug 24, 2023
    Last Update Posted:
    Aug 24, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anxiety Disorders

    Study Results

    No Results Posted as of Aug 24, 2023