Obsessive-compulsive DisorderOCD-VRET2NCT07206199
Virtual Reality Exposure Therapy for Obsessive-Compulsive Disorder: Outpatients Trial
A study testing exposure therapy in virtual reality and Wait list in people with Obsessive-compulsive Disorder, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obsessive-compulsive Disorder
- What is being tested?
- exposure therapy in virtual reality and Wait list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Mar 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of OCD (F42) using currently valid DSM-V and ICD-11
- Fluent in Czech
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pavla Stopková contact
Czechia1 site, 1 recruiting
- Recruiting
Nationa Institute of Mental Health
Klecany, Česká Republika, 250 67
Martina Janíková, +420775594595, martina.janikova@nudz.cz
Iveta Hocko Fajnerová, +420608501034, iveta.fajnerova@nudz.cz
About this study
Official title: Virtual Reality Exposure Therapy in Patients With Obsessive-Compulsive Disorder: A Randomized Controlled Trial in Outpatients
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.
Read the detailed description
The virtual environment of so called "OCD house" is used as a tool for the therapy. Immersive VR glasses Meta Quest 2 are used to visualize the environment.
During exposure therapy, relevant virtual stimuli can be freely combined involving common objects and situations in the home that may trigger OCD symptoms and hoarding. Target stimuli (VR elements) are divided into several sets corresponding to OCD subtypes. During the session, the therapist can modify the level of difficulty via four standardized levels according to the individual needs of clients.
The therapeutic application enables direct interaction with stimuli in the environment of the virtual house and garden, thanks to hand tracking. The hand tracking and hand gestures are used also to control the movement in the environment by the patients, but direct head and body rotations and small movements are enabled by the VR headset. The psychotherapist can follow the patient actions and control the settings of the environment (e.g.selection of relevant stimuli, level of difficulty) using a streaming app on the tablet or a mobile phone and advise the patient where necessary. The level of difficulty is gradually increased during the progress of the therapy.
- Conditions
- Obsessive-compulsive Disorder
- Being tested
- exposure therapy in virtual reality, Wait list
- Keywords
- Obsessive-compulsive disorder, virtual reality, Virtual reality exposure therapy, within-subject design, Outpatients
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure therapy in virtual realityBehavioural
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.
Wait listOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: exposure therapy in virtual reality; Other: Wait list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
The SUDS is a visual analog scale in which the participant rates his/her anxiety/discomfort based on a range between 1 (no anxiety/discomfort) and 10 (very severe anxiety/discomfort).
Measured: During In-Sessions: week 1-5 of experimental VRET condition
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.
Measured: Before In-Sessions: week 1-5 of experimental VRET condition
The Igroup Presence Questionnaire (IPQ)
The scale includes 3 subscales SP (spatial presence), INV (involvement) and REAL (experienced realism) with score range 0-7. Higher scores indication higher sense of presence. This measure might be positivelly associated with positive outcome.
Measured: Immediately after the first session of VR exposure therapy.
Simulator Sickness Questionnaire (SSQ)
The scale evaluates cybersickness symptoms in three subscales: nausea (N), oculomotor disturbance (O), disorientation (D). Total simulator sickness raw score 0-48 (adjusted total score 0-180). Higher scores on each scale indicatestronger perceptions of the underlying sickness symptoms and aretherefore undesired. This measure might be negatively associated with positive outcome and sense of presence.
Measured: Immediately after the first session of VR exposure therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start20 Mar 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subject design. Waiting list period followed by active treatment period of the same length (5 weeks).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iveta Fajnerová, National Institute of Mental Health, Czech Republic
- Investigators
- Iveta Hocko Fajnerová, Ph.D., Study director, National Institute of Mental Health (NIMH)Pavla Stopková, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206199
- Sponsor's protocol ID
- NU23-04-00402-Study2
- Acronym
- OCD-VRET2
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the publication of results
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Exposure Therapy in Patients With Obsessive-Compulsive Disorder: A Randomized Controlled Trial in Outpatients
- ClinicalTrials.gov ID
- NCT07206199
- Acronym / sponsor ID
- OCD-VRET2 / NU23-04-00402-Study2
- Conditions
- Obsessive-compulsive Disorder
- Keywords
- Obsessive-compulsive disorder, virtual reality, Virtual reality exposure therapy, within-subject design, Outpatients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Institute of Mental Health, Czech RepublicUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The virtual environment of so called "OCD house" is used as a tool for the therapy. Immersive VR glasses Meta Quest 2 are used to visualize the environment.
During exposure therapy, relevant virtual stimuli can be freely combined involving common objects and situations in the home that may trigger OCD symptoms and hoarding. Target stimuli (VR elements) are divided into several sets corresponding to OCD subtypes. During the session, the therapist can modify the level of difficulty via four standardized levels according to the individual needs of clients.
The therapeutic application enables direct interaction with stimuli in the environment of the virtual house and garden, thanks to hand tracking. The hand tracking and hand gestures are used also to control the movement in the environment by the patients, but direct head and body rotations and small movements are enabled by the VR headset. The psychotherapist can follow the patient actions and control the settings of the environment (e.g.selection of relevant stimuli, level of difficulty) using a streaming app on the tablet or a mobile phone and advise the patient where necessary. The level of difficulty is gradually increased during the progress of the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-subject design. Waiting list period followed by active treatment period of the same length (5 weeks).
| Arm | Type | Receives |
|---|---|---|
| Within-subject comparison of a waiting list condition with exposure therapy in VR | Experimental | Behavioral: exposure therapy in virtual reality, Other: Wait listPatients 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of OCD (F42) using currently valid DSM-V and ICD-11
- Fluent in Czech
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exposure therapy in virtual realityParticipants 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. | Behavioural | Within-subject comparison of a waiting list condition with exposure therapy in VR |
| Wait listThe 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. | Other | Within-subject comparison of a waiting list condition with exposure therapy in VR |
Primary outcome
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) self report version
Time frame: 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 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.
The Beck Depression Inventory
Time frame: 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 (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Beck Anxiety Inventory (BAI)
Time frame: 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.
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.
Hierarchy of fears
Time frame: 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.
Patients describe and rate their most feared situations or stimuli on a 10-point scale (1-10).
The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2)
Time frame: 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
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).
4 secondary outcomes
Subjective Units of Distress Scale (SUDS)
Time frame: During In-Sessions: week 1-5 of experimental VRET condition
Adherence to exposures
Time frame: Before In-Sessions: week 1-5 of experimental VRET condition
The Igroup Presence Questionnaire (IPQ)
Time frame: Immediately after the first session of VR exposure therapy.
Simulator Sickness Questionnaire (SSQ)
Time frame: Immediately after the first session of VR exposure therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Description and illustration images of the software used in the study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD used in the publication of results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pavla Stopková contact
Iveta Hocko Fajnerová, Ph.D. study director
National Institute of Mental Health (NIMH)
Pavla Stopková, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exposure therapy in virtual reality and Wait list in people with Obsessive-compulsive Disorder, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iveta Hocko Fajnerová (+420608501034, iveta.fajnerova@nudz.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) self report version (time frame: 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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.