The Effect of Immersive Virtual Reality Treatment With Cognitive Behaviour Therapy for Obsessive-Compulsive Disorder

Shanghai Mental Health Center

Status: Not yet enrolling

Conditions: Obsessive-Compulsive Disorder; Virtual Reality

Treatments: Behavioral: Traditional ERP; Combination Product: The combination of exposure and response prevention (ERP) and VR

Study type: Interventional

Funder types: Other

Identifiers

NCT04534907

SMHC-OCD-009

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

VR(ERP）

Active Comparator group

Description:

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

Treatment:

Combination Product: The combination of exposure and response prevention (ERP) and VR

traditional ERP

Active Comparator group

Description:

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

Treatment:

Behavioral: Traditional ERP