Immersive Virtual Reality & Obsessive Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05841017
• Other study ID #: AC-282
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: February 12, 2024

Study information

• Verified date: May 2023
• Source: Consorci Hospitalari de Vic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: February 12, 2024
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Psychotherapy with Immersive Virtual Reality support.
Psychoeducational group intervention and cognitive behavioural therapy individual intervention.

Locations

Country	Name	City	State
Spain	Consorci Hospitalari de Vic	Vic	Barcelona, Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Hospitalari de Vic

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.