KCT0007360尚未招募未知
Emotional Freedom Techniques vs Written Exposure Therapy vs Waiting List for Posttraumatic Stress Disorder: A Randomized Clinical Trial
Kyung Hee University Oriental Medical Center0 个研究点目标入组 180 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 64(Year)（—）
- 性别
- Female
入选标准
- •Patients with PTSD
- •1. Females aged 19 to under 65
- •2. Participants diagnosed with PTSD by structured clinical interview (SCID-5, Structured Clinical Interview for DSM-5)
- •3. Participants who had symptoms of PTSD for more than three months
- •4. Participants who can make regular visits once a week for six weeks
- •5. Participants who voluntarily agreed to participate in the study
- •Healthy controls
- •1. Females aged 19 to under 65
- •2. Participants who do not have traumatic experiences screened by LEC-5
- •3. Participants who do not meet diagnostic criteria of Post-Traumatic Stress Disorder by structured clinical interview (SCID-5, Structured Clinical Interview for DSM-5)
- •4. Participants who do not have functional/organic disorders, and clinically meaningful findings in the history taking and physical examination.
- •5. Participants with Patient Health Questionnaire-9 (PHQ-9) = 4
- •6. Participants with Generalized Anxiety Disorder Screener-7 (GAD-7) = 4
- •7. Participants with Patient Health Questionnaire-15 (PHQ-15) = 5
- •8. Participants who voluntarily agreed to participate in the study
排除标准
- •Patients with PTSD
- •1. Participants with risks of suicide by C-SSRS
- •2. Participants with current or past history of schizophrenia or bipolar disorder
- •3. Participants with alcohol or other substance use disorders within 8 weeks
- •4. Participants with history of cerebrovascular diseases, brain tumor, or traumatic brain injury (however, participants with mild traumatic brain injury will not be excluded)
- •5. Participants with history of neurological or systemic diseases that may affect central nervous system
- •6. Participants with history of acute infectious disease within two weeks
- •7. Participants with history of taking following medications within four weeks; systemic steroids, antipsychotics, antidepressants, benzodiazepines, sleep medications (e.g. zolpidem) (however, participants who take the medications in stable doses for more than 2 weeks will not be excluded)
- •8. Participants with history of taking following medications within two weeks; antibiotics
- •9. Participants who have been vaccinated within four weeks or have plan for vaccination during the study period
- •10. Participants with moderate or higher cognitive impairment
- •11. Participants in medical conditions requiring inpatient treatment
- •12. Participants who received medication or other intervention in other clinical trials within one month
- •13. Participants who received psychotherapy within six months
- •14. Pregnant or lactating women
- •15. Participants who do not use medically acceptable contraception during the study period
- •16. Participants who are determined as unsuitable by the investigators
- •Healthy controls
- •1. Participants with history of major mental disorders
- •2. Participants with history of neurological or systemic diseases that may affect central nervous system
- •3. Participants with history of cerebrovascular diseases, brain tumor, or traumatic brain injury
- •4. Participants with history of acute infectious disease within two weeks
- •5. Participants with history of taking following medications within four weeks; systemic steroids, antipsychotics, antidepressants, benzodiazepines, sleep medications (e.g. zolpidem) (however, participants who taking the medications in stable doses for more than 2 weeks will not be excluded)
- •6. Participants with history of taking following medications within two weeks; antibiotics
- •7. Participants who have been vaccinated within four weeks or have plan for vaccination during the study period
- •8. Participants in medical conditions requiring inpatient treatment
- •9. Participants with moderate or higher cognitive impairment
- •10. Participants who received medication or other intervention in other clinical trials within one month
- •11. Pregnant or lactating women
- •12. Participants who do not use medically acceptable contraception during the study period
- •13. Participants who are determined as unsuitable by the investigators
- •MRI specific exclusion criteria (common for patients with PTSD and healthy controls)
- •1. Participants who have ferrous containing metal substance within the body
- •2. Participants who have difficulty in tolerating enclosed, small spaces, because of claustrophobia
研究者
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