None listed
Conditions
Interventions
Medical Device : Study Groups:
Experimental Group: Standard treatment + Digital Therapeutic Device (DTx)
Control Group: Standard treatment only
Study Design
1) Digital Therapeutic Device Treatment Du
Sponsors
Waycen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 years or older. 2) Individuals who meet the DSM-5 diagnostic criteria for panic disorder or have been diagnosed with panic disorder (F41.0) according to ICD-10. 3) Individuals with a score of 11 or higher on the Korean version of the self-reported Panic Disorder Severity Scale (PDSS-SR) and a score of 2 or higher on item 1 (number of panic attacks experienced in the past week). 4) Individuals who have no difficulty reading and writing in Korean. 5) Individuals who have no difficulty using a mobile application with general-purpose devices (such as a smartphone, tablet PC, or smart band). 6) Individuals who have received a full explanation of this clinical trial, understood it, voluntarily decided to participate, and provided written informed consent to comply with the study guidelines.
Exclusion criteria
Exclusion criteria: 1) Individuals who have any of the following psychiatric symptoms at the time of screening: schizophrenia spectrum disorder, manic episode, major depressive episode, or substance use disorder. 2) Individuals who have been diagnosed with any of the following psychiatric disorders at any point in their lifetime: schizophrenia spectrum disorder, bipolar disorder, or substance use disorder. 3) Individuals who have an uncontrolled or severe systemic physical illness requiring hospitalization at the time of screening. 4) Individuals who have attempted suicide within three months prior to screening and are deemed to be at high risk of suicide by a psychiatrist. 5) Individuals who have newly started or are currently undergoing any form of cognitive behavioral therapy (CBT) within three months prior to screening. *Includes CBT for panic disorder as well as any other CBT interventions. 6) Individuals with visual or auditory impairments, or cognitive impairments (e.g., dementia). 7) Individuals deemed unsuitable for participation in the clinical trial for any other reason, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Panic Disorder Severity Scale score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Hospital Anxiety and Depression Scale (HADS) score;Change in Agoraphobic Cognitions Questionnaire (ACQ) score;Change in Body Sensations Questionnaire (BSQ) score;Compliance during the treatment period (8 weeks);Safety endpoint | — |
Countries
Korea, Republic of
Contacts
Public ContactJIMIN LEE
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed