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

NCT ID: NCT06010654

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-14
• Study Completion Date: 2024-07-24

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

Detailed Description

Purpose: This study is designed to evaluate the safety and efficacy of ANZEILAX, a digital therapeutic intervention delivered via a smartphone application. The application incorporates Acceptance and Commitment Therapy (ACT), a type of cognitive behavioral therapy, and self-communicational techniques to treat Generalized Anxiety Disorder(GAD). The study amis to assess the effectiveness to thie digital therapeutic in reducing anxiety symptoms and improving overall mental health outcomes in individuals with GAD.

Study Population: The study will enroll adults aged 19 years older who have completed at least a high school education.

Study Duration: The intervention period will last for 10 weeks, followed by a follow-up visit at Week 15 to assess long-term outcomes and effects after the completion of the intervention.

Intervention: Participants will use the smartphone application for a period of 10 weeks. The application is recommended to be used twice daily, with a minimum required use of once per day. It can be used during flexible time periods, such as before sleep, after waking up, or at any other when the participant feels it is necessary. The application delivers Acceptance and Commitment Therapy(ACT). It also encourages self-referencing activities, which help participants focus on and reflects upon experiences associated with positive emotions. Additionally, the application promotes self-distancing techniques, helping participants to avoid excessive immersion in negative emotional experiences.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Software as a Medical device

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ANZEILAX

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HAII corp.ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaejin Kim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Location Yonsei University Health System, Gangnam Severance Hospital

Locations

Yonsei University Health System, Gangnam Severance Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 41086425 (View on PubMed)

Other Identifiers

3-2023-0018

Identifier Type: -

Identifier Source: org_study_id