Virtual Reality Exposure Therapy for Obsessive-Compulsive Disorder: Outpatients Trial

NCT07206199 | Recruiting

• 1 other identifier: NU23-04-00402-Study2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of virtual reality exposure therapy (VRET) as a treatment for obsessive-compulsive disorder (OCD). This study focuses on patients receiving treatment in outpatient psychiatry or clinical psychology settings, utilizing a within-subject design for comparison. Patients first complete informed consent and baseline questionnaires and are placed on a waiting list for five weeks. After this period, they are reassigned to the active (experimental) group, which will receive five sessions of exposure therapy in virtual reality over a subsequent five-week period. The treatment effect will be evaluated using pre/post assessments, as well as monitoring adherence to exposure and response prevention assignments.

Conditions

Obsessive-compulsive Disorder

Keywords

Obsessive-compulsive disorder; virtual reality; Virtual reality exposure therapy; within-subject design; Outpatients

Outcome Measures

Primary Outcomes (5)

• The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) self report version

  The Y-BOCS is a 19-item scale assessing the severity of obsessive-compulsive symptoms. Raw score range from 0 to 40, where 0 = no symptoms and 40 = very severe symptoms with highly impaired daily functioning.

  Applied repeatedly: 1) Before the assignment to the waitlist condition, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session.

• The Beck Depression Inventory

  The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.

  Applied repeatedly: 1) Before the assignment to the waitlist condition, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session.

• Beck Anxiety Inventory (BAI)

  BAI is an inventory of anxiety symptoms with 18 items rated on a 5-point Likert scale (0-4). Score range from 0 to 72, with higher scores indicating more severe anxiety symptoms.

  Applied repeatedly: 1) Before the assignment to the waitlist condition, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session.

• Hierarchy of fears

  Patients describe and rate their most feared situations or stimuli on a 10-point scale (1-10).

  Applied repeatedly: 1) Before the assignment to the waitlist condition, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session.

• The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2)

  The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2) is used to measure self-reported symptoms of trait anxiety with higher score indicating higher anxiety levels (score range 20-80).

  Applied repeatedly: 1) Before the assignment to the waitlist, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session

Secondary Outcomes (4)

• Subjective Units of Distress Scale (SUDS)

  During In-Sessions: week 1-5 of experimental VRET condition

• Adherence to exposures

  Before In-Sessions: week 1-5 of experimental VRET condition

• The Igroup Presence Questionnaire (IPQ)

  Immediately after the first session of VR exposure therapy.

• Simulator Sickness Questionnaire (SSQ)

  Immediately after the first session of VR exposure therapy.

Study Arms (1)

Within-subject comparison of a waiting list condition with exposure therapy in VR

EXPERIMENTAL

Patients first complete informed consent and baseline questionnaires and are placed on a waiting list for five weeks. After this period, they are reassigned to the active group, which receives five sessions of exposure therapy in virtual reality over a subsequent five-week period. The treatment effect will be evaluated using pre/post assessments, as well as monitoring adherence to exposure and response prevention assignments.

Behavioral: exposure therapy in virtual reality; Other: Wait list

Interventions

exposure therapy in virtual reality BEHAVIORAL

Participants complete five 30-40-minute sessions of exposure therapy administered via a virtual reality headset once a week. The exposure involves exposure to various symptom-provoking scenarios in the virtual house environment. Scenarios can be adjusted to distinct OCD dimensions: contamination/cleaning, fear-of-harm/checking symmetry/ordering, and also to symptoms of hoarding. Stimuli can be also freely combined across different dimensions, so that the scenarios fit the individual needs.

Within-subject comparison of a waiting list condition with exposure therapy in VR

Wait list OTHER

The patients are assigned to a waitlist period for 5 weeks. During this period they are not allowed to change any treatment (phramacotherapy and/or psychoterapy as usual) started prior to the trial.

Within-subject comparison of a waiting list condition with exposure therapy in VR

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of OCD (F42) using currently valid DSM-V and ICD-11
• Fluent in Czech

You may not qualify if:

• Any other psychiatric, neurological and serious somatic illness
• Substance abuse
• Psychotropic medication (e.g. benzodiazepines) except antidepressants, antipsychotic medication and hypnotics.
• Contradictions to using a virtual reality (e.g., epilepsy, balance problems)
• Pregnancy
• Cardiostimulator and mental implants

Sponsors & Collaborators

• National Institute of Mental Health, Czech Republic: lead

Study Sites (1)

Nationa Institute of Mental Health

Klecany, Česká Republika, 250 67, Czechia

RECRUITING

Related Links

• Description and illustration images of the software used in the study.

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Implosive Therapy; Waiting Lists

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Iveta Hocko Fajnerová, Ph.D.

  National Institute of Mental Health (NIMH)

  STUDY DIRECTOR

• Pavla Stopková, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iveta Hocko Fajnerová

CONTACT

+420608501034; iveta.fajnerova@nudz.cz

Pavla Stopková

CONTACT

pavla.stopkova@nudz.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor

Model Details: Within-subject design. Waiting list period followed by active treatment period of the same length (5 weeks).

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: March 20, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the publication of study data.
• Access Criteria: The anonymized preprocessed behavioral data will be shared using an institutional open access or journal repository. Additional raw data access requests will be reviewed using an online form. Requestors will be required to sign a data access agreement.

Locations

CZ (1)