The Effect of Immersive Virtual Reality Treatment With Cognitive Behaviour Therapy for Obsessive-Compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder, Virtual Reality
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The combination of exposure and response prevention (ERP) and VR
Traditional ERP
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Virtual Reality, cognitive-behavioral therapy, Exposure and Response /Ritual Prevention
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
Sites / Locations
- Shanghai Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
VR(ERP)
traditional ERP
Arm 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
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
Outcomes
Primary Outcome Measures
Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score
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
Change in Obsessive Compulsive Inventory-Revised(OCI-R)
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.
Change in Beck Depression Inventory(BDI)
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 Beck Anxiety Inventory (BAI)
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.
Chinese version of Working Alliance Inventory-Short Form (WAI-SR)
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).
Simulator Sickness Questionnaire(SSQ)
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.
Full Information
NCT ID
NCT04534907
First Posted
August 23, 2020
Last Updated
April 16, 2023
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT04534907
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 30, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder, Virtual Reality
Keywords
Virtual Reality, cognitive-behavioral therapy, Exposure and Response /Ritual Prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VR(ERP)
Arm Type
Active Comparator
Arm 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
Arm Title
traditional ERP
Arm Type
Active Comparator
Arm 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
Intervention Type
Combination Product
Intervention Name(s)
The combination of exposure and response prevention (ERP) and VR
Intervention Description
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
Behavioral
Intervention Name(s)
Traditional ERP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score
Description
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.
Time Frame
from baseline to 8weeks
Secondary Outcome Measure Information:
Title
Change in Obsessive Compulsive Inventory-Revised(OCI-R)
Description
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.
Time Frame
from baseline to 8weeks
Title
Change in Beck Depression Inventory(BDI)
Description
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.
Time Frame
from baseline to 8weeks
Title
Change in Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
from baseline to 8weeks
Title
Chinese version of Working Alliance Inventory-Short Form (WAI-SR)
Description
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).
Time Frame
assessed only once after the entire treatment at the end of the eighth week. (at the end week 8 )
Title
Simulator Sickness Questionnaire(SSQ)
Description
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.
Time Frame
The SSQ should be assessed each time after the VR+ERP treating for OCD patients. (at week 2, 3, 4, 5, 6, 7)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Wang, PhD,MD
Phone
+86 34773516
Email
wangzhen@smhc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Wang, PhD,MD
Phone
+86 64387250
Email
wangzhen@smhc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Wang, PhD,MD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Effect of Immersive Virtual Reality Treatment With Cognitive Behaviour Therapy for Obsessive-Compulsive Disorder
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