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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
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.
Yonsei University Health System, Gangnam Severance Hospital
Seoul, South Korea
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.)
Time frame: Measured at Baseline, Week 5, Week 10, and Week 15.
Beck Anxiety Inventory
The Beck Anxiety Inventory (BAI) is a 21-tem, self-report tool designed to measure the severity of anxiety symptoms. It includes items that assess cognitive, emotional, and physical aspects of anxiety. The BAI is specifically designed to differentiate betwwen symptoms of ansiety and depression, with a focus on physical symptoms typically assocaiated with anxiety.
Time frame: Measured at Baseline, Week 5, Week 10, and Week 15.
Penn State Worry Questionnaire
The Penn State Worry Questionnaire (PSWQ) is a self-report tool developed to assess the presence and severity of pathologicla worry. It is designed to identify excessive, uncontrollabel worry, a key feafure of generalized anxiety disorder.
Time frame: Measured at Baseline, Week 5, Week 10, and Week 15.
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale(HADS) is a self-report tool used to assess anxiety symptoms, focusing on both physical and emotional aspects of anxiety. It is specifically designed for use in hospital settings to evaluate both anxiety and depression in patients.
Time frame: Measured at Baseline, Week 5, Week 10, and Week 15.
Treatment adherence
During the clinical trial, Treatment As Usual (TAU) will vary depending on the severity of the participants' conditions, making it difficult to uniformly control across all subjects. Therefore, treatment adherence will be specifically assessed in the treatment group, where participants receive both TAU and ANZEILAX intervention. To evaluate adherence to the DTx, user log data from the DTx application will be collected and analyzed.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Measured at Week 5 and Week 10
Satisfaction evaluation
Satisfaction with both Treatment As Usual (TAU) for anxiety and the digital therapeutic (DTx), ANZEILAX, will be assessed using two questions. The first question will ask participants to rate their satisfaction on a scale of 0 to 10, with 0 being "not satisfied" and 10 being "extremely satisfied." The second question will be an open-ended prompt asking participants to "write about their experiences during the treatment," allowing for qualitative feedback on their personal feelings and perceptions.
Time frame: Measured at Week 5 and Week 10