Immersive Virtual Reality & Obsessive Compulsive Disorder

Sponsor
Consorci Hospitalari de Vic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05841017
Collaborator
(none)
98
1
2
12
8.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Psychotherapy with Immersive Virtual Reality support.
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness of the Immersive Virtual Reality in the Psychological Treatment of Obsessive Compulsive Disorder
Actual Study Start Date :
Feb 13, 2023
Anticipated Primary Completion Date :
Aug 11, 2023
Anticipated Study Completion Date :
Feb 12, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

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.
Psychoeducational group intervention and cognitive behavioural therapy individual intervention.

No Intervention: Control group

Usual clinic care.

Outcome Measures

Primary Outcome Measures

  1. Obsessive Compulsive Disorder symptomatology. [1, 3 & 6 months.]

    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.

Secondary Outcome Measures

  1. Anxiety symptoms. [1, 3 & 6 months.]

    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.

  2. Depressive mood symptoms. [1, 3 & 6 months.]

    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.

  3. Perceived quality of life. [1, 3 & 6 months.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Consorci Hospitalari de Vic Vic Barcelona, Catalonia Spain 08500

Sponsors and Collaborators

  • Consorci Hospitalari de Vic

Investigators

  • Study Chair: Pere Roura-Poch, MD, Consorci Hospitalari de Vic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Pere Roura-Poch, Head of Epidemiology, Consorci Hospitalari de Vic
ClinicalTrials.gov Identifier:
NCT05841017
Other Study ID Numbers:
  • AC-282
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Pere Roura-Poch, Head of Epidemiology, Consorci Hospitalari de Vic
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2023