ZeroOCD: Learn to Overcome Contamination OCD With Your Smartphone

VU University of Amsterdam

Status: Not yet enrolling

Conditions: Obsessive Compulsive Disorder (OCD)

Treatments: Behavioral: Videoconferencing CBT; Behavioral: ZeroOCD

Study type: Interventional

Funder types: Other

Identifiers

NCT07194473

ZeroOCD/FP-1478

Details and patient eligibility

About

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.

Full 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.

Enrollment: 189 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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189 participants in 3 patient groups

ZeroOCD AR-CBT App + 3 therapist support sessions

Experimental group

Description:

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.

Treatment:

Behavioral: ZeroOCD

Videoconferencing CBT

Active Comparator group

Description:

Participants will receive 9 weekly sessions of manualized Cognitive Behavioral Therapy with Exposure and Response Prevention (ERP) delivered via videoconferencing by trained therapists.

Treatment:

Behavioral: Videoconferencing CBT

Waitlist control group

No Intervention group

Description:

Participants in this group will receive access to the ZeroOCD app with therapist support on request after a 10-week waiting period.