NCT07194473

Brief 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. The AR-CBT app will be compared to both an active control condition (manualized CBT via videoconferencing) and a waitlist control group.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Sep 2025

Geographic Reach
4 countries

4 active sites

Status
not yet recruiting

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 Progress39%
Sep 2025May 2027

First Submitted

Initial submission to the registry

September 3, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

September 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

1.6 years

First QC Date

September 3, 2025

Last Update Submit

September 18, 2025

Conditions

Keywords

Obsessive Compulsive DisorderAugmented RealitySmartphoneRandomized Controlled TrialCost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • 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).

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

Secondary Outcomes (13)

  • OCD symptoms (Self-report)

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

  • Fear of Contamination

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

  • Depression

    At baseline, At 10 weeks, At 24 weeks

  • Anxiety

    At baseline, At 10 weeks, At 24 weeks

  • Current Distress/Disgust

    up to ten weeks

  • +8 more secondary outcomes

Other Outcomes (3)

  • Reasons for discontinuation

    up to ten weeks

  • Socio-demographic information

    At baseline

  • Health Anxiety

    At baseline

Study Arms (3)

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.

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.

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.

Interventions

ZeroOCDBEHAVIORAL

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

Also known as: ZeroOCD AR-CBT App + 3 therapist support sessions
ZeroOCD AR-CBT App + 3 therapist support sessions

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

Videoconferencing CBT

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Thomas More Mechelen

Mechelen, Belgium

Location

Vrije Universiteit Amsterdam

Amsterdam, North Holland, 1081 BT, Netherlands

Location

Stockholm University

Stockholm, Sweden

Location

UBERN

Bern, Switzerland

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Central Study Contacts

Tar Donker, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 26, 2025

Study Start

September 21, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Deidentified participant data

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations