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Prospective Randomized Controlled Confirmatory Clinical Trial of a Digital Therapeutic Device for Panic Disorder

Development of Digital Therapeutics for Treating Panic Disorder with Cognitive Behavioral Therapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0009912
Enrollment
52
Registered
2024-11-08
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-11-14

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 : Experimental group: The test device is a software medical device designed for treating panic disorder based on cognitive behavioral therapy for panic disorder. Participants in the exp

Sponsors

SMDsolutions
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Adults aged 19 to under 65 years old ? Individuals who meet the diagnostic criteria for panic disorder according to DSM-5 or have been diagnosed with panic disorder (F41.0) according to ICD-10 ? Individuals scoring 8 or above on the Korean version of the Self-Report Panic Disorder Severity Scale (PDSS-SR) ? Individuals who have no difficulty reading and writing in Korean ? Individuals who can use a mobile application on a smartphone or tablet PC without difficulty ? Individuals who have received and understood sufficient explanation about this clinical trial, have decided to participate on their own, and have given written consent to comply with the precautions

Exclusion criteria

Exclusion criteria: Exclusion criteria include any of the following conditions, in which case the individual will be excluded from this clinical trial: ? Individuals with the following psychiatric symptoms at the baseline evaluation: Schizophrenia spectrum and other psychotic disorders, manic episodes, major depressive episodes, substance use disorders. ? Individuals who have been diagnosed with the following psychiatric conditions at any point in their life: Schizophrenia spectrum and other psychotic disorders, bipolar disorder, substance use disorders. ? Patients with uncontrolled systemic physical diseases or conditions requiring hospitalization at the time of the baseline evaluation. ? Individuals who have attempted suicide within the last month and are assessed by a psychiatrist as being at high risk for suicide. ? Individuals who have initiated or are currently participating in any cognitive behavioral therapy * Including any cognitive behavioral therapies for panic disorder as well as other types of cognitive behavioral therapy. ? Individuals with auditory or visual impairments, organic brain disorders, or neurocognitive disorders, e.g., dementia. ? Individuals deemed unsuitable for participation in the clinical trial for other reasons by the investigator. ? Individuals who have had changes in psychiatric medication within the last month, excluding PRN prescriptions of benzodiazepines.

Design outcomes

Primary

MeasureTime frame
Panic Disorder Severity Scale

Secondary

MeasureTime frame
Panic Disorder Severity Scale - Self rating;Albany Panic and Phobia Questionnaire;Beck Depression Inventory;Beck Anxiety Inventory;Clinical Global Impression-Severity;Clinical Global Impression-improvement;Change in frequency of panic attacks over the past week

Countries

Korea, Republic of

Contacts

Public ContactSoo-Jin Kwak

Seoul National University Hospital

sujinkwak.lab@gmail.com+82-2-870-3464

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026