Clinical trial NCT04534907: The Effect of Immersive Virtual Reality Treatment With Cognitive Behaviour Therapy for Obsessive-Compulsive Disorder
Official title: Effectiveness of the Immersive Virtual Reality (VR) Treatment With Cognitive Behaviour Therapy (CBT) for Obsessive-Compulsive Disorder (OCD) : A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Virtual Reality
Keywords: Virtual Reality
cognitive-behavioral therapy
Exposure and Response /Ritual Prevention
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score
timeFrame: from baseline to 8weeks
Secondary outcomes:
measure: Change in Obsessive Compulsive Inventory-Revised(OCI-R)
timeFrame: from baseline to 8weeks
measure: Change in Beck Depression Inventory(BDI)
timeFrame: from baseline to 8weeks
measure: Change in Beck Anxiety Inventory (BAI)
timeFrame: from baseline to 8weeks
measure: Chinese version of Working Alliance Inventory-Short Form (WAI-SR)
timeFrame: assessed only once after the entire treatment at the end of the eighth week. (at the end week 8 )
measure: Simulator Sickness Questionnaire(SSQ)
timeFrame: The SSQ should be assessed each time after the VR+ERP treating for OCD patients. (at week 2, 3, 4, 5, 6, 7)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Zhen Wang, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: