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NCT Number: NCT07194473

ZeroOCD: Learn to Overcome Contamination OCD With Your Smartphone

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas More Mechelen, Mechelen, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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

Exclusion criteria

  • • 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.

Treatment and study plan

ZeroOCD

Behavioral

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

Other names: ZeroOCD AR-CBT App + 3 therapist support sessions

Videoconferencing CBT

Behavioral

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. OCD symptoms (Self-report)

    Time frame: At baseline, During treatment (every week) At 10 weeks, At 24 weeks

    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.

  2. Fear of Contamination

    Time frame: At baseline, At 10 weeks, At 20 weeks (only WL condition) At 24 weeks

    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).

  3. Depression

    Time frame: At baseline, At 10 weeks, At 24 weeks

    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).

  4. Anxiety

    Time frame: At baseline, At 10 weeks, At 24 weeks

    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.

  5. Current Distress/Disgust

    Time frame: up to ten weeks

    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.

  6. Social Functioning

    Time frame: At baseline, At 10 weeks, At 24 weeks

    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).

  7. Health Related Quality of Life

    Time frame: At baseline, At 10 weeks, At 24 weeks

    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).

  8. Societal Costs of a Treatment

    Time frame: At baseline, At 10 weeks, At 24 weeks

    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.

  9. Usability

    Time frame: At 10 weeks (only ZeroOCD condition), At 20 weeks (only WL condition)

    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.

  10. Treatment Satisfaction

    Time frame: At 10 weeks (only intervention groups)

    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.

  11. Realism of AR-Environment

    Time frame: At 10 weeks (only ZeroOCD condition)

    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).

  12. Negative Effects of Treatment

    Time frame: At 10 weeks (only ZeroOCD and CBT condition), at 20 weeks (only waitlist condition)

    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.

  13. Usage Data

    Time frame: up to ten weeks (only ZeroOCD and waitlist condition)

    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.

Other outcomes

  1. Reasons for discontinuation

    Time frame: up to ten weeks

    Reasons for discontinuation: to understand why participants stop with the treatment before the end of the treatment

  2. Socio-demographic information

    Time frame: At baseline

    Socio-demographic questionnaire: To gather participant characteristics and demographics at the start of the study. This questionnaire collects information about participants' age, gender, education level, marital status, employment status, and treatment preference. It also gathers information on current or past psychological treatment and medication to confirm eligibility.

  3. Health Anxiety

    Time frame: At baseline

    Short Health Anxiety Inventory (SHAI): A self-report measure to assess the presence of health anxiety at baseline, which is an exclusion criterion if judged to be the primary driver of contamination fears. This is an 18-item measure rated on a scale from 0 to 3.

Study contacts

Contact information is provided by the study sponsor or research team.

Tar Donker, PhD

CONTACT

[email protected]

0205988265

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Collaborators

  • Stockholm University
  • Thomas More University of Applied Sciences
  • University of Bern

Registry information

Official study title

ZeroOCD: Learn to Overcome Contamination OCD With Your Smartphone: An Augmented Reality Cognitive Behavioral Therapy App for Obsessive-Compulsive Disorder: Randomized Controlled Trial

Acronym: ZeroOCD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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