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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR(ERP） | Active Comparator | The combination of exposure and response prevention (ERP) and VR will be applied twice a week for the fist two weeks. For the next four weeks, this treatment will be applied once a week. 8 times in total |
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| traditional ERP | Active Comparator | The traditional ERP will be applied twice a week for the fist two weeks. For the next four weeks, this treatment will be applied once a week. 8 times in total |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The combination of exposure and response prevention (ERP) and VR | Combination Product | The combination of exposure and response prevention (ERP) and VR aimed to investigate the combination of an immersive virtual reality environment (VRE) alongside therapist delivered CBT to reduce anxiety when the OCD patients were induced by virtual scene.Specially, patients will get the first CBT session in the first week for 90 minutes in order to gather detailed information of individual's symptom. Then the next 2 weeks, patients will get VR+ERP session twice a week. From the fourth week to the seventh week, patients weill get VR+ERP session once a week. In the end of the eighth week, patients will get the last session of the exposure-based CBT for relapse prevention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score | 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. | from baseline to 8weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Obsessive Compulsive Inventory-Revised(OCI-R) | It is an inventory of OCD symptoms with 18 items that are rated on a 5-point Likert scale. Total scores range from 0 to 72, with higher scores indicating more severe OCD symptoms. | from baseline to 8weeks |
| Change in Beck Depression Inventory(BDI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Wang, PhD,MD | Contact | +86 34773516 | wangzhen@smhc.org.cn | |
| Zhen Wang, PhD,MD | Contact | +86 64387250 | wangzhen@smhc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhen Wang, PhD,MD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
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Parallel Assignment
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| Traditional ERP | Behavioral | Patients will achieve the exposure based CBT for total 10 times excluding 8 sessions of ERP. Structured protocol described by Foa et al., 2012. Specially, patients will get the first CBT session in the first week for 90 minutes in order to gather detailed information of individual's symptom. Then the next 2 weeks, patients will get ERP session twice a week. From the fourth week to the seventh week, patients weill get ERP session once a week. In the end of the eighth week, patients will get the last session of the exposure-based CBT for relapse prevention. |
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It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms. |
| from baseline to 8weeks |
| Change in Beck Anxiety Inventory (BAI) | It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms. | from baseline to 8weeks |
| Chinese version of Working Alliance Inventory-Short Form (WAI-SR) | The WAI-SR measures three domains of the therapeutic alliance: (a) agreement between patient and therapist on the goals of the treatment (Goal); (b) agreement between patient and therapist about the tasks to achieve these goals (Task); and (c) the quality of the bond between the patient and therapist (Bond). | assessed only once after the entire treatment at the end of the eighth week. (at the end week 8 ) |
| Simulator Sickness Questionnaire(SSQ) | The SSQ has been traditionally used for simulator motion sickness measurement,The SSQ was administered immediately after each task, and the order of work was determined using the Latin square design. | The SSQ should be assessed each time after the VR+ERP treating for OCD patients. (at week 2, 3, 4, 5, 6, 7) |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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