Virtual Reality Exposure Therapy for Obsessive-Compulsive Disorder: A Randomized Controlled Trial in Inpatients
OCD-VRET1
1 other identifier
interventional
62
1 country
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). Participants are randomly assigned to one of the following interventions: a) exposure condition - the group with a standard CBT program enriched with exposure therapy in VR (VRET), b) control condition 1 - the group with a standard CBT program enriched with VR cognitive training aimed at cognitive flexibility or c) control condition 2 - standard CBT program without any additional VR intervention. The treatment effect will be evaluated using pre/post assessments, as well as monitoring adherence to exposure and response prevention assignments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2022
CompletedFirst Submitted
Initial submission to the registry
September 25, 2025
CompletedFirst Posted
Study publicly available on registry
November 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
November 24, 2025
September 1, 2025
4.1 years
September 25, 2025
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
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) At the baseline - Before the start of the first therapy session (S1), 2) Post-intervention - after the last session (S5) and 3) 2 months after the last session in the follow-up measurement (subjective Y-BOCS).
The Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Applied repeatedly for 5 weeks of the intervention (once per week) and 2 months after the last session in the follow-up measurement.
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 for 5 weeks of the intervention (once per week) and 2 months after the last session in the follow-up measurement.
Adherence to exposures
Four questions aimed at gathering information about how patients managed to perform exposures during the past week and to what extent the skills acquired during the VR exposure therapy were useful.
Immediately before each session (S1-S5) and 2 months after the last session in the follow-up measurement.
Secondary Outcomes (6)
The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2)
1) At the baseline - Before the start of the first therapy session (S1), 2) Post-intervention - after the last session (S5) and 3) 2 months after the last session in the follow-up measurement.
Six-item State-Trait Anxiety Inventory (STAI-6)
Applied repeatedly during the intervention - twice during each of the 5 weekly sessions - Immediately Pre- and Post-Session (all sessions S1-S5)
Subjective Units of Distress Scale (SUDS)
During In-Sessions: all sessions S1-S5
Anxiety Hierarchy
Baseline - Immediately before first (S1), posttreatment - after the last session (S5) + (Controlling for Baseline Score) and 2 months after the last session in the follow-up measurement.
Barratt Impusiveness Scale (BIS-11)
Immediately before the first (S1), after the last (S5) session and 2 months after the last session in the follow-up measurement.
- +1 more secondary outcomes
Other Outcomes (2)
The Igroup Presence Questionnaire (IPQ)
Immediately after second session (S2)
Simulator Sickness Questionnaire (SSQ)
Immediately after second session (S2)
Study Arms (3)
Virtual reality exposure
EXPERIMENTALParticipants complete 6-week CBT program with five 30-40-minute sessions of exposure administered via a virtual reality headset (once a week). The intervention involves exposure to various symptom provoking scenarios in the virtual house environment - "OCD house". Scenarios can be adjusted to distinct OCD dimensions: contamination/cleaning, fear-of-harm/checking, symmetry/ordering. Stimuli can be also freely combined across dimensions, so that the scenarios fit to individual needs.
Cognitive flexibility training
ACTIVE COMPARATORControl group attends 6-week CBT program with five sessions of 30-40 minutes of cognitive training via virtual reality headset using "VRcity" cognitive training games.
Standard CBT without additional VR treatment
ACTIVE COMPARATORControl group completes the standard 6-week CBT program only, with no VR sessions.
Interventions
Virtual reality scenarios consists of exposures to OCD symptom provoking stimuli and response prevention (e.g. having dirty hands without washing them immediately) with the support of the therapist. The goal of VRET is sufficient reduction in anxiety and acceleration of progress in classical CBT.
Participants play series of various cognitive games previously developed in NIMH aimed at cognitive flexibility. Games are presented using immersive VR (HTC vive headset). The set includes for instance Go/No-go paradigm with a shooting range addressing inhibitory control, Flies - hit a fly game addressing set-shifting and Castle game addressing spatial memory and reversal learning.
Standart CBT program (performed in all groups). The program involves regular group and individual psychotherapy sessions 5 days per 6 weeks.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Mental Health
Klecany, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Iveta Fajnerová, Ph.D.
National Institute of Mental Health (NIMH)
- PRINCIPAL INVESTIGATOR
Pavla Stopková, Ph.D.
National Institute of Mental Health (NIMH)
Central Study Contacts
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
- Supervisor
Study Record Dates
First Submitted
September 25, 2025
First Posted
November 24, 2025
Study Start
November 15, 2022
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
November 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Immediately after the publication of study results, at least for 5 years.
- 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.
IPD used in the publication of results, minimum of 5 years