Obsessive-Compulsive DisorderOCD-VRET1NCT07245134
Virtual Reality Exposure Therapy for Obsessive-Compulsive Disorder: A Randomized Controlled Trial in Inpatients
A study testing Exposure Therapy (Virtual Reality), Cognitive flexibility training and Standard CBT program without VR interventions in people with Obsessive-Compulsive Disorder and Virtual Reality Exposure Therapy, 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). 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… Read more about this study
- Who is it for?
- Ages 17 to 55 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, Virtual Reality Exposure Therapy, Virtual Reality Cognitive Training
- What is being tested?
- Exposure Therapy (Virtual Reality), Cognitive flexibility training and Standard CBT program without VR interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Nov 2022to 30 Dec 2026
- 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 17 to 55 years
- All sexes
- No healthy volunteers
- Child, 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
National Institute of Mental Health
Klecany
Martina Janíková, +420775594595, martina.janikova@nudz.cz
Iveta 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 Inpatients
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.
Read the detailed description
The virtual environment of so called "OCD house" is used as a tool for the intervention in the experimental group. Immersive VR glasses HTC Vive Pro are used to visualize the virtual 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 behavior. 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 the clients.
The therapeutic application enables movement and direct interaction with stimuli in the environment of the virtual house and garden, thanks to a set of handhold controllers. Direct head and body rotations and small body 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 the computer and screen connected to the headset, and advise the patient where necessary. The level of difficulty is gradually increased during the progress of the therapy.
- Conditions
- Obsessive-Compulsive Disorder, Virtual Reality Exposure Therapy, Virtual Reality Cognitive Training, Cognitive Behavior Therapy
- Being tested
- Exposure Therapy (Virtual Reality), Cognitive flexibility training, Standard CBT program without VR interventions
- Keywords
- obsessive-compulsive disorder, VR exposure therapy, cognitive flexibility, Inpatient clinic
- 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 (Virtual Reality)Behavioural
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.
Cognitive flexibility trainingBehavioural
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.
Standard CBT program without VR interventionsBehavioural
Also called Cognitive Behavior Therapy
Standart CBT program (performed in all groups). The program involves regular group and individual psychotherapy sessions 5 days per 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality exposure | Experimental | Participants 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. Receives: Behavioral: Exposure Therapy (Virtual Reality) |
| Cognitive flexibility training | Active comparator | Control 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. Receives: Behavioral: Cognitive flexibility training |
| Standard CBT without additional VR treatment | Active comparator | Control group completes the standard 6-week CBT program only, with no VR sessions. Receives: Behavioral: Standard CBT program without VR interventions |
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)
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) 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.
Measured: 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.
Measured: 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.
Measured: 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)
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: 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)
The 6-item short form of the Spielberger State-Trait Anxiety Inventory is used to measure self-reported symptoms of state anxiety with higher score indicating higher anxiety levels.
Measured: 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)
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: all sessions S1-S5
Anxiety Hierarchy
The patient is asked to develope a hierarchy of feared situations ranging from most-feared at the top to least-feared at the bottom. Then, he/she rates anticipated fear, anxiety or distress for each item (score 1-10, with higher score indicating higher anxiety) - according to how distressing they feel it would be to encounter that situation. The hierarchy is used to guide a process of VRET sessions.
Measured: 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)
BIS is a 30-item scale used for self-assessment of impulsivity. Participants rate each item on a 4-point scale. Total score range from 30 to 120, where higher scores indicate higher impulsivity.
Measured: Immediately before the first (S1), after the last (S5) session and 2 months after the last session in the follow-up measurement.
Cognitive Flexibility Inventory
CFI is self-report measure of the type of cognitive flexibility necessary for replace maladaptive thoughts with more balanced thinking. It has 20-items that participants evaluate on a 7-point Likert scale. The total score ranges from 20 to 140 and higher scores indicate more cognitive flexibility.
Measured: Immediately before the first (S1), after the last (S5) session and 2 months after the last session in the follow-up measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start15 Nov 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 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 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
- NCT07245134
- Sponsor's protocol ID
- NU23-04-00402_Study1
- Acronym
- OCD-VRET1
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 24 Nov 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, minimum of 5 years
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 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 Inpatients
- ClinicalTrials.gov ID
- NCT07245134
- Acronym / sponsor ID
- OCD-VRET1 / NU23-04-00402_Study1
- Conditions
- Obsessive-Compulsive Disorder, Virtual Reality Exposure Therapy, Virtual Reality Cognitive Training, Cognitive Behavior Therapy
- Keywords
- obsessive-compulsive disorder, VR exposure therapy, cognitive flexibility, Inpatient clinic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- National Institute of Mental Health, Czech RepublicUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Nov 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). 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.
Detailed description
The virtual environment of so called "OCD house" is used as a tool for the intervention in the experimental group. Immersive VR glasses HTC Vive Pro are used to visualize the virtual 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 behavior. 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 the clients.
The therapeutic application enables movement and direct interaction with stimuli in the environment of the virtual house and garden, thanks to a set of handhold controllers. Direct head and body rotations and small body 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 the computer and screen connected to the headset, 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual reality exposure | Experimental | Behavioral: Exposure Therapy (Virtual Reality)Participants 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 comparator | Behavioral: Cognitive flexibility trainingControl 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 comparator | Behavioral: Standard CBT program without VR interventionsControl group completes the standard 6-week CBT program only, with no VR sessions. |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 (Virtual Reality)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. | Behavioural | Virtual reality exposure |
| Cognitive flexibility trainingParticipants 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. | Behavioural | Cognitive flexibility training |
| Standard CBT program without VR interventionsAlso: Cognitive Behavior TherapyStandart CBT program (performed in all groups). The program involves regular group and individual psychotherapy sessions 5 days per 6 weeks. | Behavioural | Standard CBT without additional VR treatment |
Primary outcome
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Time frame: 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 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 (BDI)
Time frame: Applied repeatedly for 5 weeks of the intervention (once per week) and 2 months after the last session in the follow-up measurement.
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 for 5 weeks of the intervention (once per week) and 2 months after the last session in the follow-up measurement.
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.
Adherence to exposures
Time frame: Immediately before each session (S1-S5) and 2 months after the last session in the follow-up measurement.
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.
6 secondary outcomes
The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2)
Time frame: 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)
Time frame: 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)
Time frame: During In-Sessions: all sessions S1-S5
Anxiety Hierarchy
Time frame: 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)
Time frame: Immediately before the first (S1), after the last (S5) session and 2 months after the last session in the follow-up measurement.
Cognitive Flexibility Inventory
Time frame: Immediately before the first (S1), after the last (S5) session and 2 months after the last session in the follow-up measurement.
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 24 Nov 2025.
- Individual participant dataSharing planned: Yes. IPD used in the publication of results, minimum of 5 years
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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 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 (Virtual Reality), Cognitive flexibility training and Standard CBT program without VR interventions in people with Obsessive-Compulsive Disorder and Virtual Reality Exposure Therapy, 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 24 Nov 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 Fajnerová (+420-608501034, 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) (time frame: 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 study lists 4 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 24 Nov 2025.