None listed
Conditions
Interventions
Others(Psychotherapy) : Patients with PTSD will be randomly allocated to one of the three groups.
1. Emotional Freedom Therapy (EFT): 40 min/time, 1 time/week, for 5 weeks
2. Written Exposure Therapy
Sponsors
Kyung Hee University Oriental Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinician-Administered PTSD Scale (CAPS) | — |
Secondary
| Measure | Time frame |
|---|---|
| PTSD Checklist-5 (PCL-5);Beck Depression Inventory-II (BDI-II);Beck Anxiety Inventory (BAI);Patient Health Questionnaire-15 (PHQ-15);Insomnia Severity Index (ISI);EuroQol-5 Dimension-5 Levels;WHO QoL assessment instrument abbreviated version (WHOQOL-BREF);Clinical Global Impression-Severity, Improvement;Columbia-Suicide Severity Rating Scale (C-SSRS);Brain Magnetic Resonance Imaging (Brain MRI);Emotional rating and facial expression to emotional stimuli;Blood sample (BDNF, FKBP5, SLC64A4, BDNF, COMT, HTR2A, GRIK4, KCNK2, OPRM1, SLC6A4, IL-1ß, IL-2, IL-4, IL-6, IL-10, TNF-a, IFN-?, cortisol, C-reactive Protein);Pain threshold, Cutaneous sensory threshold;Pattern identification questionnaire: Cold, Heat, Deficiency, and Excess pattern scores;Empathy Quotient (EQ);Social Network Questionnaire;Toronto Alexithymia Scale (TAS-20);Perceived Stress Scale (PSS);IBS Symptom severity scale (IBS-SSS);Gut Quotient (GQ);Gastrointestinal Symptom Rating Scale (GSRS) | — |
Countries
Korea, Republic of
Contacts
Public ContactYunna Kim
Kyung Hee University Oriental Medical Center
Outcome results
None listed