Clinical trial NCT05841017: Immersive Virtual Reality & Obsessive Compulsive Disorder
Official title: Effectiveness of the Immersive Virtual Reality in the Psychological Treatment of Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder
Immersive Virtual Reality
psychological treatment
Lead sponsor: Consorci Hospitalari de Vic
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Obsessive Compulsive Disorder symptomatology.
timeFrame: 1, 3 & 6 months.
Secondary outcomes:
measure: Anxiety symptoms.
timeFrame: 1, 3 & 6 months.
measure: Depressive mood symptoms.
timeFrame: 1, 3 & 6 months.
measure: Perceived quality of life.
timeFrame: 1, 3 & 6 months.
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Consorci Hospitalari de Vic
state: Barcelona, Catalonia
Study officials:
affiliation: Consorci Hospitalari de Vic
name: Pere Roura-Poch, MD
role: STUDY_CHAIR
References:
citation: Fineberg NA, Hollander E, Pallanti S, Walitza S, Grunblatt E, Dell'Osso BM, Albert U, Geller DA, Brakoulias V, Janardhan Reddy YC, Arumugham SS, Shavitt RG, Drummond L, Grancini B, De Carlo V, Cinosi E, Chamberlain SR, Ioannidis K, Rodriguez CI, Garg K, Castle D, Van Ameringen M, Stein DJ, Carmi L, Zohar J, Menchon JM. Clinical advances in obsessive-compulsive disorder: a position statement by the International College of Obsessive-Compulsive Spectrum Disorders. Int Clin Psychopharmacol. 2020 Jul;35(4):173-193. doi: 10.1097/YIC.0000000000000314.
citation: Hamatani S, Tsuchiyagaito A, Nihei M, Hayashi Y, Yoshida T, Takahashi J, Okawa S, Arai H, Nagaoka M, Matsumoto K, Shimizu E, Hirano Y. Predictors of response to exposure and response prevention-based cognitive behavioral therapy for obsessive-compulsive disorder. BMC Psychiatry. 2020 Sep 4;20(1):433. doi: 10.1186/s12888-020-02841-4.
citation: Laforest M, Bouchard S, Bosse J, Mesly O. Effectiveness of In Virtuo Exposure and Response Prevention Treatment Using Cognitive-Behavioral Therapy for Obsessive-Compulsive Disorder: A Study Based on a Single-Case Study Protocol. Front Psychiatry. 2016 Jun 13;7:99. doi: 10.3389/fpsyt.2016.00099. eCollection 2016.
citation: Langener S, Van Der Nagel J, van Manen J, Markus W, Dijkstra B, De Fuentes-Merillas L, Klaassen R, Heitmann J, Heylen D, Schellekens A. Clinical Relevance of Immersive Virtual Reality in the Assessment and Treatment of Addictive Disorders: A Systematic Review and Future Perspective. J Clin Med. 2021 Aug 18;10(16):3658. doi: 10.3390/jcm10163658.
citation: van Bennekom MJ, de Koning PP, Gevonden MJ, Kasanmoentalib MS, Denys D. A Virtual Reality Game to Assess OCD Symptoms. Front Psychiatry. 2021 Jan 22;11:550165. doi: 10.3389/fpsyt.2020.550165. eCollection 2020.