Getting rid of your obsessions with your own smartphone: Augmented Reality app-based Cognitive Behaviour Therapy for Obsessive Compulsive Disorder – Health-economic and process evaluation alongside a

Background: Dwindling budgets and rising numbers of people suffering from mental disorders put increasing strain on our health and care facilities.

In order to relieve some of the pressure on our overextended health and care system, the need for scalable and accessible health care solutions is imminent.

If the COVID-19 pandemic has made one thing clear, it is that digital mental health care (eMental health) is the future and that right now is the moment to act.

Aim: Capitalizing on ground-breaking AR technology, the proposed project entitled AR-CBT for OCD provides an accessible, scalable, and low-cost therapy solution for a disorder that comes with pervasive stigma, namely obsessive-compulsive disorder (OCD).

AR-CBT for OCD takes the next step in eMental health, namely an (semi-)automated Augmented Reality (AR) Cognitive Behaviour Treatment (CBT) delivered via an app for mobile devices that patients can follow in the convenience of their own home and in their own time and that requires only minimal (digital) therapist support.Methods: AR-CBT for OCD develops an encompassing app-based treatment for OCD named “ZeroOCD”, and tests it for clinical effectiveness in a Randomized Controlled Trial (RCT), against an active control condition; CBT via videoconferencing.

OCD patients will be recruited from the general population in four different countries: Sweden, Switzerland, Belgium, and The Netherlands. The ZeroOCD application can be accessed from users` own mobile device.

AR stimuli include, among others, various types of contamination, ranging from virtual germs and dirt on kitchen desks, to germs and dirt on toilets and hands.

Both the experimental and control treatments will be delivered over a period of 16 weeks in participants` natural environments. The primary outcome measure will be OCD symptoms as measured with the Yale Brown Obsessive Compulsive Scale. Baseline, 16-weeks post-test and 6-month follow-up self-report assessments will be administered online.

Analysis will be based on intention-to-treat.

Imperative for implementation purposes, we will also carry out a health-economic evaluation alongside the RCT by integrating research on costs. Depressive symptoms, quality of life, absence at work and use of healthcare are secondary outcome measures. Incremental costs per Quality Adjusted Life Year gained will be calculated with the EQ-5D-5L.

A second incremental cost-effectiveness ratio will be calculated based on functioning level. Finally, based on the results, a budget impact analysis will be conducted according to international guidelines.

In addition, a process-evaluation is simultaneously carried out in each of the aforementioned countries to examine the current implementation barriers and solutions for VR and AR (together, called XR) mental health apps on the level of the patient, the therapist, mental health institutes and (inter)national policy regulations and guidelines.

This evaluation will result in recommendations for strategies for a European-wide implementation of evidence-based AR eMental health apps in mental healthcare.

In a separate study, we will upload ZeroOCD to the app stores and examine participant usage data including required therapist support.

Impact: Our treatment, ZeroOCD, which only requires a smartphone in terms of hardware, has the potential to provide an effective and scalable treatment that can simply be downloaded from the app store.

Furthermore, beyond developing an encompassing therapy to effectively treat a burdensome, severe disorder, AR-CBT for OCD provides a template for the treatment of other mental health disorders.

The economical knowledge gained from the proposed project, along with the strategies recommended for implementation, has the potential to realize step-changes in the provision of cost-effective evidence-based scalable mental healthcare and relieve pressure on health and care facilities.