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A Clinical Study to Evaluate the Effectiveness and Safety of the Digital Therapeutic ‘ANZEILAX-GREEN’ in Improving Anxiety Symptoms

A Single Blind, Parallel arm, Multi-institution Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics ‘ANZEILAX-GREEN’ for Managing Anxiety Disorders Not Otherwise Specified

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011690
Enrollment
116
Registered
2026-03-09
Start date
2026-03-16
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Participants diagnosed with anxiety disorder not otherwise specified will be randomly assigned to either the intervention group or the control group. Participants in the intervention

Sponsors

Chung-Ang Univerisity Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Individuals aged 13 to 39 years who meet the diagnostic criteria for Anxiety Disorder, Unspecified (ICD-10 code: F41.9). 2. Individuals with mild or higher anxiety severity, defined as a score of 8 or higher on the Beck Anxiety Inventory (BAI). 3. Individuals who are currently taking prescribed medication related to Anxiety Disorder, Unspecified. 4. Individuals whose type or dosage of psychiatric medications (including antipsychotics, anxiolytics, antidepressants, or mood stabilizers) has not been changed for at least 28 days prior to the date of clinical trial enrollment and up to the present. PRN (Pro Re Nata) medications are excluded from this criterion. 5. For minor participants, individuals who have obtained written consent from a legally authorized representative. 6. Individuals who fully understand the purpose, content, and procedures of the clinical trial and voluntarily agree to participate, providing a handwritten signature on the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals who are unable to read the informed consent form. 2. Individuals who are not proficient in using a smartphone. 3. Patients who are currently receiving treatment for major psychiatric disorders, such as bipolar disorder or schizophrenia, that are severe enough to require hospitalization at the time of screening. 4. Individuals with neurological disorders such as brain injury, epilepsy, or cognitive impairment. 5. Individuals with intellectual disability. 6. Individuals with substance use disorder or alcohol use disorder. 7. Individuals who have had a significant suicide risk within the past three months. 8. Individuals who are currently receiving cognitive behavioral therapy (CBT) for anxiety, depression, or mood disorders, or who have participated in such therapy within the past six months. 9. Individuals who are considered inappropriate for participation in this clinical trial at the investigator’s discretion.

Design outcomes

Primary

MeasureTime frame
Generalized Anxiety Disorder 7-item(GAD-7)

Secondary

MeasureTime frame
Patient Health Questionnaire-9(PHQ-9);Hamilton Anxiety Rating Scale(HAM-A);Rosenberg Self Esteem Scale(RSES); Clinical Global Impression-Severity(CGI-S); Clinical Global Impression-Improvement (CGI-I);Treatment adherence;Satisfaction

Countries

Korea, Republic of

Contacts

Public ContactHyun chan Hwang

Chung-Ang Univerisity Hospital

sleep@cauhs.or.kr+82-2-6299-1508

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 20, 2026