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

NCT ID: NCT04534907

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-31

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.

Conditions

Obsessive-Compulsive Disorder; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR(ERP）

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Traditional ERP

Intervention Type: 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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Zhen Wang

vice-president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhen Wang, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Zhen Wang, PhD,MD

Role: CONTACT

wangzhen@smhc.org.cn

+86 34773516

Zhen Wang, PhD,MD

Role: CONTACT

wangzhen@smhc.org.cn

+86 64387250

Other Identifiers

SMHC-OCD-009

Identifier Type: -

Identifier Source: org_study_id