Effectiveness of the Immersive Virtual Reality (VR) Treatment With Cognitive Behaviour Therapy (CBT) for Obsessive-Compulsive Disorder (OCD) : A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score
研究概览
简要总结
This study will evaluate the clinical effectiveness ofthe Immersive Virtual Reality alongside exprosure and response Prevention (ERP) Treatment in cognitive-Behavioral Therapy for Obsessive-compulsive Disorder, and the underlying neural mechanism by electroencephalography (EEG) and eye-tracking methodology .
详细描述
The current study aims to the clinical effectiveness of the Immersive Virtual Reality alongside exprosure and response Prevention (ERP) Treatment in cognitive-Behavioral Therapy for Obsessive-compulsive Disorder. 30 OCD patients whose symptom were mainly associated with "contamination/clean" , "Symmetry/precision", "Examination" and "Sex" will be randomized into two groups (i.e. VR ERP or ERP). The treatment will be performed twice a week for the first two weeks. And for the next 4 week, the treatment for OCD patients will be undertook once a week. There will be 8 times in total. The investigators will assess thhe OCD patients'symptom severity in the baseline, 2 weeks, 4weeks and after 8 weeks of the whole combined treatment. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale (PSS), Pittsburgh sleep quality index (PSQI) and side-effect questionnaire will be obtained by a trained investigator. The patients will also get individual's data of EEG and eye-movement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18-50 years old;
- •Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for OCD;
- •Y-BOCS total score > or = 16, discontinued medication for at least 8 weeks before
- •the enrollment or the paitients' clinical medication is stable for at least a month (the dose and the types of drugs) .>or＝9 years education
排除标准
- •Any axis I psychiatric disorder comorbidity
- •Participants who have received any forms of psychological therapy in the past.
- •Patients cannot tolerate or adapt to the somatic discomfort caused by VR .
- •Prior history of neurological disease (e.g., epilepsy) or brain surgery for traumatic brain injury
- •Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
- •Any current significant medical condition.
- •serious suicide risk
结局指标
主要结局
Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score
时间窗: from baseline to 8weeks
It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.
次要结局
- Change in Beck Depression Inventory(BDI)(from baseline to 8weeks)
- Change in Obsessive Compulsive Inventory-Revised(OCI-R)(from baseline to 8weeks)
- Chinese version of Working Alliance Inventory-Short Form (WAI-SR)(assessed only once after the entire treatment at the end of the eighth week. (at the end week 8 ))
- Change in Beck Anxiety Inventory (BAI)(from baseline to 8weeks)
- Simulator Sickness Questionnaire(SSQ)(The SSQ should be assessed each time after the VR+ERP treating for OCD patients. (at week 2, 3, 4, 5, 6, 7))
研究者
Zhen Wang
vice-president
Shanghai Mental Health Center