Obsessive Compulsive Disorder (OCD)ZeroOCDNCT07194473
ZeroOCD: Learn to Overcome Contamination OCD With Your Smartphone
A study testing ZeroOCD and Videoconferencing CBT in people with Obsessive Compulsive Disorder (OCD), run by VU University of Amsterdam at 4 sites in 4 countries.
Trial summary
This study is a three-arm randomized controlled trial designed to evaluate the efficacy of a smartphone-based augmented reality (AR) cognitive behavioral therapy (CBT) app, called ZeroOCD, for individuals with elevated contamination-related obsessive-compulsive disorder (OCD) symptoms. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- ZeroOCD and Videoconferencing CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 21 Sep 2025to May 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • OCD symptoms, mean score > 7 on the Yale Brown Obsessive Compulsive Scale (Y-BOCS)
- Fear of contamination OCD symptoms, mean score > 6 on the Padua Inventory contamination fear subscale (PI)
- Having access to a compatible smartphone
- Having an internet connection
- Proficiency in one of the countries' languages (i.e., Dutch/ Flemish, German, or Swedish)
- Willing to participate in the research study and provide informed consent
Who cannot join
- • Having been diagnosed with bipolar or psychotic disorder (self-report)
- Severe depressive symptoms (Patient Health Questionnaire, PHQ-9, score > 20)
- Reporting suicidality (PHQ-9, item 9 > 2 points at screening)
- Fear of contamination due to disorder other than OCD (clinical judgment based on results from the Yale Brown Obsessive Compulsive Scale, Y-BOCS, Generalized Anxiety Disorder-7 items, GAD-7, Short Health Anxiety Inventory, SHAI)
- Parallel psychological treatment
- Non-stable dosage of psychoactive medication during the last three months or planned changes during the study period.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Belgium1 site
Thomas More Mechelen
Mechelen
Tom van Daele, PhD, 32 2 218 16 20, tom.vandaele@thomasmore.be
Netherlands1 site
Vrije Universiteit Amsterdam
Amsterdam, North Holland, 1081 BT
Sweden1 site
Stockholm University
Stockholm
Per Carlbring, PhD, 08-16 39 20 of 070-666 7 666, per.carlbring@psychology.su.se
Switzerland1 site
UBERN
Bern
Thomas Berger, PhD, +41 31684 34 07, thomas.berger@unibe.ch
About this study
Official title: ZeroOCD: Learn to Overcome Contamination OCD With Your Smartphone: An Augmented Reality Cognitive Behavioral Therapy App for Obsessive-Compulsive Disorder: Randomized Controlled Trial
This study is a three-arm randomized controlled trial designed to evaluate the efficacy of a smartphone-based augmented reality (AR) cognitive behavioral therapy (CBT) app, called ZeroOCD, for individuals with elevated contamination-related obsessive-compulsive disorder (OCD) symptoms. The AR-CBT app will be compared to both an active control condition (manualized CBT via videoconferencing) and a waitlist control group.
Read the detailed description
Obsessive-compulsive disorder (OCD) is a prevalent and disabling condition, with contamination fears being one of its most common presentations. While Cognitive-Behavioral Therapy (CBT) with Exposure and Response Prevention (ERP) is a first-line treatment, many individuals face barriers to accessing it, such as cost, stigma, and availability of therapists. This multicenter trial, conducted in the Netherlands, Belgium, Sweden, and Switzerland, will recruit a total of 189 individuals experiencing contamination-related obsessive-compulsive symptoms. Participants will be randomized to one of three study conditions (allocation ratio 2:2:1): The first group (n = 75) receives access to ZeroOCD, an augmented reality (AR) based smartphone application, which provides CBT and ERP for contamination fears, along with three therapist support sessions via videoconferencing. The second group (n = 75) receives weekly CBT for OCD via videoconferencing (nine sessions in total). The third group is a waitlist control group (n = 39), who will receive access to the smartphone application with minimal therapist support on request after 10 weeks in the study. The study aims to evaluate the effectiveness of the ZeroOCD intervention compared to both a waitlist control and videoconferencing CBT, and to assess cost-effectiveness and usability. Assessments are conducted at baseline, 10 weeks post-randomization, and at 6-month follow-up for the intervention groups. Participants in the waitlist group complete assessments at baseline, 10 weeks post-randomization, and receive access to the ZeroOCD intervention 10 weeks after randomization. Further, the waitlist group will complete an assessment 20 weeks post-randomization. The study is a multicenter trial involving participants in Switzerland, the Netherlands, Belgium, and Sweden.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- ZeroOCD, Videoconferencing CBT
- Keywords
- Obsessive Compulsive Disorder, Augmented Reality, Smartphone, Randomized Controlled Trial, Cost-effectiveness
- 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.
ZeroOCDBehavioural
Also called ZeroOCD AR-CBT App + 3 therapist support sessions
The ZeroOCD app contains the following components:
psychoeducation, detecting obsessive thoughts, coping with obsessions, goal setting, fear curve explanation, exposure with AR, re-exposure with AR, exposure hierarchy, exposure in real-life, re-exposure in real life and relapse prevention
Videoconferencing CBTBehavioural
Videoconferencing CBT contains the following chapters:
psychoeducation, detecting obsessive thoughts, coping with obsessions, goal setting, fear curve explanation, exposure hierarchy, exposure in real-life, re-exposure in real life and relapse prevention
| Study group | Role | What they receive |
|---|---|---|
| ZeroOCD AR-CBT App + 3 therapist support sessions | Experimental | Participants will use the ZeroOCD smartphone application, which delivers 9 modules of augmented reality exposure therapy and cognitive behavioral therapy principles. This group will also receive 3 videoconferencing sessions with a therapist at the beginning, middle, and end of the 10-week treatment period. Receives: Behavioral: ZeroOCD |
| Videoconferencing CBT | Active comparator | Participants will receive 9 weekly sessions of manualized Cognitive Behavioral Therapy with Exposure and Response Prevention (ERP) delivered via videoconferencing by trained therapists. Receives: Behavioral: Videoconferencing CBT |
| Waitlist control group | No intervention | Participants in this group will receive access to the ZeroOCD app with therapist support on request after a 10-week waiting period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCD Symptoms (Interview)
Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Change from baseline in the observer-rated severity of OCD symptoms. This is a 10-item, clinician-rated scale that provides separate subtotals for the severity of obsessions and compulsions. Total scores range from 0 to 40, with higher scores indicating more severe symptoms. The Y-BOCS is also used for the eligibility (mean score > 7).
Measured: At baseline, At 10 weeks, At 20 weeks (only WL condition) At 24 weeks
Secondary outcomes (13)
OCD symptoms (Self-report)
4-item Obsessive-Compulsive Inventory (OCI-4): Change from baseline in the self-reported OCD symptom severity. This shorter form of the OCI-R consists of 4 Items that quantify the symptom severity related to OCD. Each item is rated on a scale from 0 to 4, with total scores ranging from 0 to 16, with higher scores indicating more severe symptoms.
Measured: At baseline, During treatment (every week) At 10 weeks, At 24 weeks
Fear of Contamination
Padua Inventory (PI) Contamination Fear Subscale: Change from baseline in the self-reported fear of contamination. This is a 10-item subscale that quantifies the severity of contamination-related obsessions, with each item rated on a 5-point Likert scale. A score of 6 or higher on this scale is an inclusion criterion for the study. The PI is also used for the eligibility (mean score > 6).
Measured: At baseline, At 10 weeks, At 20 weeks (only WL condition) At 24 weeks
Depression
Patient Health Questionnaire-9 (PHQ-9): Change from baseline in self-reported depressive symptom severity. This is a 9-item measure where each item corresponds to a DSM-5 criterion for major depression. Scores range from 0 to 27, and a score of >20 is an exclusion criterion. The PHQ-9 is also used for the eligibility (severe depressive symptoms: score > 20; suicidality: item 9 score > 2).
Measured: At baseline, At 10 weeks, At 24 weeks
Anxiety
Generalized Anxiety Disorder 7-item scale (GAD-7): Change from baseline in self-reported anxiety symptom severity. This is a 7-item measure with scores ranging from 0 to 21. It will also be used at baseline to help determine if contamination fears are due to GAD rather than OCD.
Measured: At baseline, At 10 weeks, At 24 weeks
Current Distress/Disgust
Subjective Units of Distress Scale (SUDS): Measurement of current distress and disgust levels before, during, and after exposure tasks within the ZeroOCD app. This is an ecological momentary assessment (EMA) where participants rate their distress on a visual analog scale from 0 to 10.
Measured: up to ten weeks
Social Functioning
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0): Change from baseline in self-reported general functioning and disability. This is a 36-item measure that evaluates functioning across six major life domains (e.g., cognition, mobility, life activities).
Measured: At baseline, At 10 weeks, At 24 weeks
Health Related Quality of Life
EQ-5D-5L measures change from baseline in self-reported health-related quality of life. This is a 5-item standardized questionnaire that evaluates health status across five domains (e.g., mobility, self-care, pain/discomfort).
Measured: At baseline, At 10 weeks, At 24 weeks
Societal Costs of a Treatment
Treatment Inventory of Costs in Patients with Psychiatric Disorders (TiC-P): Change from baseline in the utilization of healthcare services and productivity losses. This is a 36-item self-report measure used for the cost-effectiveness analysis.
Measured: At baseline, At 10 weeks, At 24 weeks
Usability
System Usability Scale (SUS): A global assessment of the subjective usability of the ZeroOCD app, measured post-treatment. This is a 10-item questionnaire with total scores ranging from 0 to 100, where higher scores indicate greater perceived usability.
Measured: At 10 weeks (only ZeroOCD condition), At 20 weeks (only WL condition)
Treatment Satisfaction
Client Satisfaction Questionnaire (CSQ): A measure of client satisfaction with the received treatment, assessed post-treatment. This is an 8-item self-report measure with total scores ranging from 8 to 32, where higher scores indicate greater satisfaction.
Measured: At 10 weeks (only intervention groups)
Realism of AR-Environment
Realism subscale of the IGroup Presence Questionnaire (IPQ): A measure to assess the perceived realism of the augmented reality (AR) environment, administered post-treatment to the ZeroOCD group. This is a 4-item subscale relevant for AR with each item assessed on a 7-point Likert scale (from -3 to 3).
Measured: At 10 weeks (only ZeroOCD condition)
Negative Effects of Treatment
Negative Effects Questionnaire (NEQ): A measure to evaluate any negative effects of the psychological treatments, assessed at post-treatment and follow-up. This is a 20-item questionnaire where participants report on the occurrence, negative impact, and attributed cause of potential negative events.
Measured: At 10 weeks (only ZeroOCD and CBT condition), at 20 weeks (only waitlist condition)
Usage Data
To understand the dose-response relationship in treatment effectiveness by analyzing how participants interact with the ZeroOCD app. This involves collecting data automatically from the app for participants in the intervention condition. Data points include the frequency and duration of practice during AR exposure, time spent in each module, number of modules and pages completed, and number of log-ins.
Measured: up to ten weeks (only ZeroOCD and waitlist condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start21 Sep 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 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 Disorder (OCD)Studies 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
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, Stockholm University, Thomas More University of Applied Sciences
- Responsible party
- Principal investigator, Tara Donker, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194473
- Sponsor's protocol ID
- ZeroOCD/FP-1478
- Acronym
- ZeroOCD
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZeroOCD: Learn to Overcome Contamination OCD With Your Smartphone: An Augmented Reality Cognitive Behavioral Therapy App for Obsessive-Compulsive Disorder: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07194473
- Acronym / sponsor ID
- ZeroOCD / ZeroOCD/FP-1478
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- Obsessive Compulsive Disorder, Augmented Reality, Smartphone, Randomized Controlled Trial, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- University of Bern, Stockholm University, Thomas More University of Applied Sciences
- Study start
- 21 Sep 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Sep 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.
This study is a three-arm randomized controlled trial designed to evaluate the efficacy of a smartphone-based augmented reality (AR) cognitive behavioral therapy (CBT) app, called ZeroOCD, for individuals with elevated contamination-related obsessive-compulsive disorder (OCD) symptoms. The AR-CBT app will be compared to both an active control condition (manualized CBT via videoconferencing) and a waitlist control group.
Detailed description
Obsessive-compulsive disorder (OCD) is a prevalent and disabling condition, with contamination fears being one of its most common presentations. While Cognitive-Behavioral Therapy (CBT) with Exposure and Response Prevention (ERP) is a first-line treatment, many individuals face barriers to accessing it, such as cost, stigma, and availability of therapists. This multicenter trial, conducted in the Netherlands, Belgium, Sweden, and Switzerland, will recruit a total of 189 individuals experiencing contamination-related obsessive-compulsive symptoms. Participants will be randomized to one of three study conditions (allocation ratio 2:2:1): The first group (n = 75) receives access to ZeroOCD, an augmented reality (AR) based smartphone application, which provides CBT and ERP for contamination fears, along with three therapist support sessions via videoconferencing. The second group (n = 75) receives weekly CBT for OCD via videoconferencing (nine sessions in total). The third group is a waitlist control group (n = 39), who will receive access to the smartphone application with minimal therapist support on request after 10 weeks in the study. The study aims to evaluate the effectiveness of the ZeroOCD intervention compared to both a waitlist control and videoconferencing CBT, and to assess cost-effectiveness and usability. Assessments are conducted at baseline, 10 weeks post-randomization, and at 6-month follow-up for the intervention groups. Participants in the waitlist group complete assessments at baseline, 10 weeks post-randomization, and receive access to the ZeroOCD intervention 10 weeks after randomization. Further, the waitlist group will complete an assessment 20 weeks post-randomization. The study is a multicenter trial involving participants in Switzerland, the Netherlands, Belgium, and Sweden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| ZeroOCD AR-CBT App + 3 therapist support sessions | Experimental | Behavioral: ZeroOCDParticipants will use the ZeroOCD smartphone application, which delivers 9 modules of augmented reality exposure therapy and cognitive behavioral therapy principles. This group will also receive 3 videoconferencing sessions with a therapist at the beginning, middle, and end of the 10-week treatment period. |
| Videoconferencing CBT | Active comparator | Behavioral: Videoconferencing CBTParticipants will receive 9 weekly sessions of manualized Cognitive Behavioral Therapy with Exposure and Response Prevention (ERP) delivered via videoconferencing by trained therapists. |
| Waitlist control group | No intervention | –Participants in this group will receive access to the ZeroOCD app with therapist support on request after a 10-week waiting period. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • OCD symptoms, mean score > 7 on the Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Key exclusion criteria (6 listed)
- • Having been diagnosed with bipolar or psychotic disorder (self-report)
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 |
|---|---|---|
| ZeroOCDAlso: ZeroOCD AR-CBT App + 3 therapist support sessionsThe ZeroOCD app contains the following components: psychoeducation, detecting obsessive thoughts, coping with obsessions, goal setting, fear curve explanation, exposure with AR, re-exposure with AR, exposure hierarchy, exposure in real-life, re-exposure in real life and relapse prevention | Behavioural | ZeroOCD AR-CBT App + 3 therapist support sessions |
| Videoconferencing CBTVideoconferencing CBT contains the following chapters: psychoeducation, detecting obsessive thoughts, coping with obsessions, goal setting, fear curve explanation, exposure hierarchy, exposure in real-life, re-exposure in real life and relapse prevention | Behavioural | Videoconferencing CBT |
Primary outcome
OCD Symptoms (Interview)
Time frame: At baseline, At 10 weeks, At 20 weeks (only WL condition) At 24 weeks
Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Change from baseline in the observer-rated severity of OCD symptoms. This is a 10-item, clinician-rated scale that provides separate subtotals for the severity of obsessions and compulsions. Total scores range from 0 to 40, with higher scores indicating more severe symptoms. The Y-BOCS is also used for the eligibility (mean score > 7).
13 secondary outcomes
OCD symptoms (Self-report)
Time frame: At baseline, During treatment (every week) At 10 weeks, At 24 weeks
Fear of Contamination
Time frame: At baseline, At 10 weeks, At 20 weeks (only WL condition) At 24 weeks
Depression
Time frame: At baseline, At 10 weeks, At 24 weeks
Anxiety
Time frame: At baseline, At 10 weeks, At 24 weeks
Current Distress/Disgust
Time frame: up to ten weeks
Social Functioning
Time frame: At baseline, At 10 weeks, At 24 weeks
Health Related Quality of Life
Time frame: At baseline, At 10 weeks, At 24 weeks
Societal Costs of a Treatment
Time frame: At baseline, At 10 weeks, At 24 weeks
Usability
Time frame: At 10 weeks (only ZeroOCD condition), At 20 weeks (only WL condition)
Treatment Satisfaction
Time frame: At 10 weeks (only intervention groups)
Realism of AR-Environment
Time frame: At 10 weeks (only ZeroOCD condition)
Negative Effects of Treatment
Time frame: At 10 weeks (only ZeroOCD and CBT condition), at 20 weeks (only waitlist condition)
Usage Data
Time frame: up to ten weeks (only ZeroOCD and waitlist condition)
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 26 Sep 2025.
- Individual participant dataSharing planned: Yes. Deidentified participant data
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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.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZeroOCD and Videoconferencing CBT in people with Obsessive Compulsive Disorder (OCD), run by VU University of Amsterdam at 4 sites in 4 countries.
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 6 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: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Netherlands, Sweden, Switzerland. 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 Tar Donker, PhD (0205988265, t.donker@vu.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCD Symptoms (Interview) (time frame: At baseline, At 10 weeks, At 20 weeks (only WL condition) At 24 weeks). 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 26 Sep 2025.