None listed
Conditions
Interventions
Behavioral : The intervention is 'Hwa-free', a smartphone application developed for stress improvement. It is based on Acceptance and Commitment Therapy (ACT). Participants will install the applicatio
Sponsors
Dong-eui University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men and women aged 19 to 80 years. 2. Individuals diagnosed with Hwa-Byung using the Hwa-Byung Diagnostic Interview Schedule (HBDIS). 3. Individuals who have voluntarily signed the informed consent form after receiving a clear explanation of the purpose and characteristics of this clinical study.
Exclusion criteria
Exclusion criteria: 1. Individuals who have started new treatments (pharmacotherapy, Korean medicine treatment, non-pharmacological therapy, etc.) for Hwa-Byung or have significantly changed the dosage or frequency of existing treatments within the last 4 weeks. 2. Individuals who have participated in other interventional clinical trials within the last 4 weeks. 3. Individuals planning to start new treatments (pharmacotherapy, Korean medicine treatment, non-pharmacological therapy, etc.) for Hwa-Byung during the study period. 4. Individuals diagnosed with and currently receiving treatment for unstable (uncontrollable) schizophrenia, bipolar disorder, or other psychiatric disorders within the last 6 months. 5. Individuals diagnosed with and receiving treatment for severe chronic diseases or terminal illnesses (e.g., malignant tumors, tuberculosis, chronic liver disease, interstitial pneumonia, chronic kidney disease, chronic heart disease, other rare metabolic diseases, etc.). 6. Cases where adherence to the protocol's treatment, visits, or questionnaire completion is deemed difficult. 7. Other cases deemed inappropriate for participation by the clinical investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Application User Experience Survey results (Main components: 'Treatment Content Evaluation', 'App User Experience', 'General Feedback for Improvement') | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline (Visit 1) in Hwa-Byung Scale score;Changes from baseline (Visit 1) in VAS-HS score;Changes from baseline (Visit 1) in BDI-II score;Changes from baseline (Visit 1) in STAI score;Changes from baseline (Visit 1) in STAXI score;Changes from baseline (Visit 1) in AAQ-II score;Changes from baseline (Visit 1) in EQ-5D-5L/EQ-VAS scores;Changes in Heart Rate Variability (HRV) data from baseline (Visit 1);Application compliance (Number of days used, total usage time, frequency and time of use by content, etc.);Incidence rate and severity of Adverse Events (AEs) | — |
Countries
Korea, Republic of
Contacts
Public ContactChan-Young Kwon
Dong-eui University
Outcome results
None listed