Clinical trial

Effectiveness of the Immersive Virtual Reality (VR) Treatment With Cognitive Behaviour Therapy (CBT) for Obsessive-Compulsive Disorder (OCD) : A Randomized Controlled Study

Name

SMHC-OCD-009

Description

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 .

Trial arms

Trial start

2023-12-30

Estimated PCD

2023-12-31

Trial end

2024-12-31

Status

Not yet recruiting

Treatment

The combination of exposure and response prevention (ERP) and VR

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.

Arms:

VR(ERP）

Traditional ERP

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.

Arms:

traditional ERP

Size

Primary endpoint

Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score

from baseline to 8weeks

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2023-04-18

1 organization

Organization

Shanghai Mental Health Center