None listed
Conditions
Interventions
Medical Device : 1. subjects: patients with depression and suicide risk findings
2. Main Intervention Description:
- Intervention group: Emotional disorder treatment software using virtual reality te
Sponsors
Yonsei University Yongin Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who agreed to participate in the study who were 19 years of age or older and 50 years of age or younger 2) Subjects with a score of 9 or higher on the Mental Health Screening Questionnaire (PHQ-9) - A cutoff point of 9 was proposed in the Korean scale standardization study for clinical trial groups (An Je-yong et al., 2013). 3) Subjects with major depressive disorder (F32, F33) on the Korean version of the MINI international Neuropsychiatric Interview (MINI; Yoo Sang-woo et al., 2006) and no psychotic symptoms 4) Subjects with a score of 2 or higher but lower than 9 on the suicidal tendency assessment scale of the Korean version of the MINI international Neuropsychiatric Interview - Subjects who scored 9 or lower on the suicidal tendency assessment scale of the Korean version of the MINI module C and who did not attempt suicide within the past month (those who answered ‘no’ to item C5) were selected as subjects.
Exclusion criteria
Exclusion criteria: 1) Subjects who have difficulty using virtual reality (VR) equipment 2) Subjects who have a suicidal tendency assessment score of 10 or higher on the Korean version of the MINI international Neuropsychiatric Interview or who answered “yes” to item C5 (excluding research participation, psychiatric intensive treatment including crisis intervention and drug treatment, and suicide crisis intervention program, implemented immediately) • During the trial period (visit 1 to visit 8), subjects whose suicide risk increased to the extent that it was difficult to participate in the clinical trial or whose depressive disorder worsened based on self-report or clinical expert evaluation will be dropped midway and will be implemented with psychiatric intensive treatment including crisis intervention and drug treatment 3) Subjects who correspond to psychotic disorder or addictive disorder in the clinical evaluation interview 4) Subjects who have taken antidepressants, antianxiety drugs for the purpose of treating depression, or antipsychotic drugs for the purpose of treating depression in the past month 5) Pregnant or lactating women 6) Foreigners who cannot read the consent form and Illiterate 7) Other persons who are deemed incapable of participating in this clinical trial by the investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| K-QIDS-C (Depression Symptom Rating Scale-Clinician Evaluation) score change | — |
Secondary
| Measure | Time frame |
|---|---|
| PHQ-9 (Mental) Health Screening Assessment), MINI-C (Suicidality Assessment), GAD-7 (Generalized Anxiety Scale), PSS (Stress Perception Scale) score change;PROVE (Depression Symptom and Mental Health Protection-Vulnerability Factor Assessment) score change;FIBSER (Antidepressant Matrix Evaluation) score change;Score change of WHOQOL-BREF (Korean version of World Health Organization Quailty of Life Scale) | — |
Countries
Korea, Republic of
Contacts
Public ContactKim Jihye
Yonsei University Yongin Severance Hospital
Outcome results
None listed