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

HAII

Status: Completed

Conditions: Generalized Anxiety Disorder

Treatments: Device: Software as a Medical device

Study type: Interventional

Funder types: Industry

Identifiers

NCT06010654

3-2023-0018

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Experimental Group

Experimental group

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:

Device: Software as a Medical device

Control Group

No Intervention group

Description:

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