Immersive Virtual Reality & Obsessive Compulsive Disorder

Study Overview
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Brief Summary
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Immersive VR (IVR) is based on the generation and projection of images from different perspectives. Obsessive Compulsive Disorder (OCD) is considered one of the 5 most common mental disorders and one of the 20 most disabling diseases according to the World Health Organization (WHO). Its vital prevalence is about 2.5%. This study aims to establish the effectiveness of a cognitive-behavioral intervention - individual and group - using IVR in patients diagnosed with OCD compared to a group receiving standard treatment by the Mental Health Center. A sample will be obtained from the list of all patients registered in the Mental Health Service of the University Hospital of Vic (Vic, Catalonia) with the primary or secondary diagnosis of Obsessive Compulsive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM 5) and in active treatment status in the period between January 2021 and January 2023. Randomized controlled clinical trial. Variables: sociodemographic, clinical, OCD symptom follow-up and quality of life. Measurement instruments: Yale-Brown Obsessive Compulsive Scale (Y-BOCS), State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Immersive Tendencies Questionnaire (ITQ), Presence Questionnaire, EuroQoL-5D (EQ-5D). Inclusion criteria: Patients over 18 years of age with a primary or secondary diagnosis of Obsessive Compulsive Disorder with one of the following specifiers: with good or acceptable introspection (1) or with little introspection (2); persons with current activity at the Mental Health Center. Exclusion criteria: patients with a diagnosis of intellectual disability, autistic spectrum disorder, active substance-related disorders, neuro-cognitive disorder and/or severe personality disorder; acute psychopathological decompensation; insufficient command of Catalan and/or Spanish; advanced disease and/or disease that significantly hinders the follow-up of the intervention.

Official Title
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Effectiveness of the Immersive Virtual Reality in the Psychological Treatment of Obsessive Compulsive Disorder

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Behavioral: Psychotherapy with Immersive Virtual Reality support.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (≥18 years of age) Outpatient Current diagnostic of obsessive compulsive disorder with good or fair insight (1) or with poor insight (2) Follow-up by mental health network in Vic Hospital Consortium of Catalonia Signed informed consent Exclusion Criteria: Intellectual disabilities Autism spectrum disorder Active substance-related disorders Neurocognitive disorders Several personality disorders Clinical acute psychotic relapse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention group will participate in a psychoeducational group (1) and in individual psychological intervention based in Cognitive Behavioural Therapy (2). | Behavioral: Psychotherapy with Immersive Virtual Reality support.<br>* Psychoeducational group intervention and cognitive behavioural therapy individual intervention.<br>|
| No Intervention: Control group<br>Usual clinic care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obsessive Compulsive Disorder symptomatology. | Changes in score of Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Total score 0-40. Subclinical level (0-7); mild (8-15); moderate (16-23); severe (24-31) and very severe (32-40). Changes in minor categories and reduction in scores indicate improvement. | 1, 3 & 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptoms. | Changes in score of State-Trait Anxiety Inventory (STAI). Total score of State Anxiety and in Trait Anxiety is between 0-60. Decreased scores indicate improvement. | 1, 3 & 6 months. | 
| Depressive mood symptoms. | Changes in score of Beck Depression Inventory (BDI). Score range 0-63. The scores obtained would indicate low depression (0-13); mild depression (14-19); moderate depression (20-28) and severe depression (29-63). Changes in minor categories and reduction in scores indicate improvement. | 1, 3 & 6 months. | 
| Perceived quality of life. | Changes in score of European Quality of Life - 5 Dimensions (EuroQoL-5D). This scale consists of two parts, a first part that evaluates 5 dimensions: mobility, personal care, daily activities, pain/discomfort and anxiety/depression. The second part consists of a visual analogue scale graduated from 0 (worst imaginable state of health) to 100 (best imaginable state of health). In first part, lower score indicate better outcomes. In last part, higher score indicate better outcome. | 1, 3 & 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive-Compulsive Disorder, Immersive Virtual Reality, psychological treatment