The Effect of Immersive Virtual Reality Treatment With Cognitive Behaviour Therapy for Obsessive-Compulsive Disorder
- Conditions
- Obsessive-Compulsive DisorderVirtual Reality
- Interventions
- Combination Product: The combination of exposure and response prevention (ERP) and VRBehavioral: Traditional ERP
- Registration Number
- NCT04534907
- Lead Sponsor
- Shanghai Mental Health Center
- Brief Summary
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 .
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VR(ERP） The combination of exposure and response prevention (ERP) and VR 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 traditional ERP Traditional ERP 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
- Primary Outcome Measures
Name Time Method Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score 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.
- Secondary Outcome Measures
Name Time Method Change in Beck Depression Inventory(BDI) from baseline to 8weeks 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.
Change in Obsessive Compulsive Inventory-Revised(OCI-R) from baseline to 8weeks 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.
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 ) 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).
Change in Beck Anxiety Inventory (BAI) from baseline to 8weeks 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.
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) 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.
Trial Locations
- Locations (1)
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China