NCT05841017

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2024

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

March 29, 2023

Last Update Submit

May 2, 2023

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive DisorderImmersive Virtual Realitypsychological treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Anxiety symptoms.

    1, 3 & 6 months.

  • Depressive mood symptoms.

    1, 3 & 6 months.

  • Perceived quality of life.

    1, 3 & 6 months.

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Control group

NO INTERVENTION

Usual clinic care.

Interventions

Psychotherapy with Immersive Virtual Reality support.BEHAVIORAL

Psychoeducational group intervention and cognitive behavioural therapy individual intervention.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Intellectual disabilities
  • Autism spectrum disorder
  • Active substance-related disorders
  • Neurocognitive disorders
  • Several personality disorders
  • Clinical acute psychotic relapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Hospitalari de Vic

Vic, Barcelona, Catalonia, 08500, Spain

Location

Related 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.

    PMID: 32433254BACKGROUND

  • 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.

    PMID: 32887553BACKGROUND

  • 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.

    PMID: 27378951BACKGROUND

  • 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.

    PMID: 34441953BACKGROUND

  • 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.

    PMID: 33551856BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Pere Roura-Poch, MD

    Consorci Hospitalari de Vic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Epidemiology

Study Record Dates

First Submitted

March 29, 2023

First Posted

May 3, 2023

Study Start

February 13, 2023

Primary Completion

August 11, 2023

Study Completion

February 12, 2024

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)