Clinical trial to evaluate the safety, efficacy, and economic feasibility of virtual reality-based ‘Emotion to Emotion Therapy’ for post-traumatic stress disorder patients
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0007845
- Lead Sponsor
- Wonkwang University Sanbon Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 72
1) Adult men and women aged 18 to 65
2) Those diagnosed with post-traumatic stress disorder by the Structured Clinical Interview for DSM-5(SCID-5)
3) PC-PTSD-5 score of 3 or higher
4) A person who voluntarily decided to participate and signed the consent form
1) People with highly psychiatric disorders
? If you have delusions or hallucinations based on a recent or past medical history
? At least one episode of mania
? If you have a history of alcohol abuse or dependence
? Those at risk of suicide
2) In case of continuous administration of substances that are judged to affect symptom induction except for concomitant drugs
3) Those with congenital diseases, central nervous system, peripheral nervous system disease, endocrine system disease, immunological disease, heart, liver, or kidney problems
4) Those who are pregnant or lactating
5) Those who have participated in other clinical studies in the past month or are currently participating in other clinical studies
6) Those in charge of clinical trials or those in charge of clinical trials who are judged to be difficult to conduct other clinical trials
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Korean version of PTSD Checklist-5
- Secondary Outcome Measures
Name Time Method The Clinical Global Impression – Improvement scale;Korean version of Posttraumatic Growth Inventory;Five Facet Mindfulness Questionnaire Short Form;Patient Health Questionnaire-15;Hospital Anxiety and Depression Scale;Korean version of Insomnia severity index;Hwa-Byung Scale;EuroQoL-5 Dimension;EuroQoL-Visual analogue scale;cost assessment;Mentalizing the Rooms of Mind;The Core Seven-Emotions Inventory Short Form;Subjective Units of Disturbance Scale;Heart Rate Variation;Quantative Encephalogram