KCT0009382已完成Unknown
Multicenter, randomization, clinical control group, evaluator blinding, exploratory clinical trial to evaluate clinical effectiveness and safety of suicide prevention effect for patients with major depressive disorder using emotional disorder treatment software (CHEEU Forest) using virtual reality technology test
Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 50(Year)（—）
- 性别
- All
入选标准
- •1. Selection criteria for clinical trial group and clinical control group
- •1) Men and women over 19 years old and under 50 years old who agreed to participate in the study.
- •2) Those with a mental health screening assessment (PHQ-9) score of 7 or higher
- •-A study on Korean scale standardization for clinical trial groups (Ahn Je-yong et al., 2013) suggested 9 points as the cut-off point, but considering that it is a screening test for the general population, the cut-off point was set at 7 points to increase sensitivity and lower specificity.
- •3) Applicable to major depressive disorder (F.32) in the Korean version of the Clinical Neuropsychiatric Interview (MINI; Yoo Sang-woo et al., 2006) and without psychotic symptoms
- •4) Those with a suicidality score of 2 or more and 9 or less on the Korean version of the MINI International Neuropsychiatric Interview
- •- Those who scored 9 points or less on the suicidality evaluation scale of the Korean version of the Clinician Evaluation Interview Module C and who did not attempt suicide within the past month (those who answered ‘No’ to item C5) were selected as subjects. (Subjects who answered yes” to item C5 were excluded from the study group and a suicide crisis intervention program was implemented.)
- •2. Healthy control group
- •1) Men and women over 19 years old and under 50 years old who agreed to participate in the study.
- •2) Below the cutoff score for depression screening (5 points or less) in the Mental Health Screening Assessment (PHQ-9)
- •3) Subjects who do not meet a significant psychiatric diagnosis in each module of the Korean version of the MINI international Neuropsychiatric Interview
- •4) Subjects with a suicidality score of 1 or less on the Korean version of the MINI International Neuropsychiatric Interview
排除标准
- •1) People who have difficulty using virtual reality VR equipment
- •2) Those with a suicidality score of 10 or more on the Korean version of the MINI International Neuropsychiatric Interview
- •(Excluding research participation, crisis intervention, psychiatric intensive treatment including drug treatment, implemented immediately)
- •3) Those who meet the level of intellectual disability in a shortened intelligence test (arithmetic & common sense) (less than 70 points in a shortened intelligence test)
- •4) During the trial period, those whose suicide risk increases or their depressive symptoms worsen to the extent that it is difficult to participate in the clinical trial according to self-report or clinician evaluation will be dropped out and receive intensive psychiatric treatment, including crisis intervention and drug treatment.
- •5) Those who are classified as psychotic disorder or addictive disorder according to clinical evaluation interview
- •6) Those with a history of taking antidepressants, anti-anxiety drugs, or antipsychotic drugs in the past 6 months
- •7) Pregnant or lactating women
- •8) Foreigners and illiterate people who cannot read the consent form
- •9) Other people who are unable to participate in this clinical trial at the discretion of the investigator
研究者
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