Clinical trial NCT06010654: Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder
Official title: A Single Blind, Parallel Arm, Single Institution Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: HAII corp.ltd
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Generalized Anxiety Disorder-7
timeFrame: Measured at Baseline, Week 5, Week 10, and Week 15.
Secondary outcomes:
measure: Beck Anxiety Inventory
timeFrame: Measured at Baseline, Week 5, Week 10, and Week 15.
measure: Penn State Worry Questionnaire
timeFrame: Measured at Baseline, Week 5, Week 10, and Week 15.
measure: Hospital Anxiety and Depression Scale
timeFrame: Measured at Baseline, Week 5, Week 10, and Week 15.
measure: Treatment adherence
timeFrame: Measured at Week 5 and Week 10
measure: Satisfaction evaluation
timeFrame: Measured at Week 5 and Week 10
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Gangnam Severance Hospital
Study officials:
affiliation: Location Yonsei University Health System, Gangnam Severance Hospital
name: Jaejin Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: