search
Back to results

Immersive Virtual Reality & Obsessive Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psychotherapy with Immersive Virtual Reality support.
Sponsored by
Consorci Hospitalari de Vic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, Immersive Virtual Reality, psychological treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Consorci Hospitalari de Vic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

The intervention group will participate in a psychoeducational group (1) and in individual psychological intervention based in Cognitive Behavioural Therapy (2).

Usual clinic care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 29, 2023
Last Updated
May 2, 2023
Sponsor
Consorci Hospitalari de Vic
search

1. Study Identification

Unique Protocol Identification Number
NCT05841017
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
August 11, 2023 (Anticipated)
Study Completion Date
February 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Consorci Hospitalari de Vic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder, Immersive Virtual Reality, psychological treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group will participate in a psychoeducational group (1) and in individual psychological intervention based in Cognitive Behavioural Therapy (2).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual clinic care.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy with Immersive Virtual Reality support.
Intervention Description
Psychoeducational group intervention and cognitive behavioural therapy individual intervention.
Primary Outcome Measure Information:
Title
Obsessive Compulsive Disorder symptomatology.
Description
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.
Time Frame
1, 3 & 6 months.
Secondary Outcome Measure Information:
Title
Anxiety symptoms.
Description
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.
Time Frame
1, 3 & 6 months.
Title
Depressive mood symptoms.
Description
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.
Time Frame
1, 3 & 6 months.
Title
Perceived quality of life.
Description
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.
Time Frame
1, 3 & 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere Roura-Poch, MD
Organizational Affiliation
Consorci Hospitalari de Vic
Official's Role
Study Chair
Facility Information:
Facility Name
Consorci Hospitalari de Vic
City
Vic
State/Province
Barcelona, Catalonia
ZIP/Postal Code
08500
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32433254
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.
Results Reference
background
PubMed Identifier
32887553
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.
Results Reference
background
PubMed Identifier
27378951
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.
Results Reference
background
PubMed Identifier
34441953
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.
Results Reference
background
PubMed Identifier
33551856
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.
Results Reference
background

Learn more about this trial

Immersive Virtual Reality & Obsessive Compulsive Disorder

We'll reach out to this number within 24 hrs