An interventional study of Software as a Medical device in Generalized Anxiety Disorder, sponsored by HAII corp.ltd. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by HAII corp.ltd · Not applicable, Interventional, and Treatment
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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.
518 studies on the registry are indexed under Generalized Anxiety Disorder; 125 are open to participants now.
This study's enrollment of 96 is above the median of 83 across 440 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →HAII corp.ltd is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
People can participate in this clinical trial only if following criteria are met.
Disease groups according to the criteria below:
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:
Exclusion Criteria:
If any of the following criteria is applicable, the person cannot participate in this clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Treatment as usual (TAU) is a standard treatment for 10 weeks, which is the clinical trial period.
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
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.
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
Plan to share: No
Ran from Aug 2023 to primary completion in Jul 2024, 11 months.
Of 183 interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Generalized Anxiety Disorder →
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