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

NCT06010654 | Completed

• 1 other identifier: 3-2023-0018
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Generalized Anxiety Disorder-7

  The primary outcome will be measured using the Generalized Anxiety Disorder 7-item (GAD-7) scale, wich assesses the severity of generalized anxiety symptoms. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety. Anxiety severity is categorized into four levels: 0-4(minimal anxiety), 5-9 (mile anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety.)

  Measured at Baseline, Week 5, Week 10, and Week 15.

Secondary Outcomes (5)

• Beck Anxiety Inventory

  Measured at Baseline, Week 5, Week 10, and Week 15.

• Penn State Worry Questionnaire

  Measured at Baseline, Week 5, Week 10, and Week 15.

• Hospital Anxiety and Depression Scale

  Measured at Baseline, Week 5, Week 10, and Week 15.

• Treatment adherence

  Measured at Week 5 and Week 10

• Satisfaction evaluation

  Measured at Week 5 and Week 10

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Treatment as usual (TAU) is a standard treatment for 10 weeks, which is the clinical trial period.

Interventions

Software as a Medical device 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.

Also known as: ANZEILAX

Experimental Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HAII corp.ltd: lead

Study Sites (1)

Yonsei University Health System, Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Related Publications (1)

• Park C, Song H, Kim H, Kim E, Jo HJ, Kim JJ, Lee JH, Kim J. Efficacy of a Smartphone-Based Digital Therapeutic (Anzeilax) in Generalized Anxiety Disorder: Randomized Controlled Trial. J Med Internet Res. 2025 Oct 14;27:e69981. doi: 10.2196/69981.

  PMID: 41086425 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Jaejin Kim, Ph.D

  Location Yonsei University Health System, Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 24, 2023
• Study Start: August 14, 2023
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)