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

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.