Predicting Obsessive-Compulsive Disorder Events in Children and Adolescents in the Wild Using a Wearable Biosensor (Wrist Angel): Protocol for the Analysis Plan of a Nonrandomized Pilot Study
Authors: Olesen Kristoffer Vinther , Lønfeldt Nicole Nadine , Das Sneha , Pagsberg Anne Katrine , Clemmensen Line Katrine Harder 
Published: August 2023

Background
Physiological signals such as heart rate and electrodermal activity can provide insight into an individual’s mental state, which are invaluable information for mental health care. Using recordings of physiological signals from wearable devices in the wild can facilitate objective monitoring of symptom severity and evaluation of treatment progress.

Objective
We designed a study to evaluate the feasibility of predicting obsessive-compulsive disorder (OCD) events from physiological signals recorded using wrist-worn devices in the wild. Here, we present an analysis plan for the study to document our a priori hypotheses and increase the robustness of the findings of our planned study.

Methods
In total, 18 children and adolescents aged between 8 and 16 years were included in this study. Nine outpatients with an OCD diagnosis were recruited from a child and adolescent mental health center. Nine youths without a psychiatric diagnosis were recruited from the catchment area. Patients completed a clinical interview to assess OCD severity, types of OCD, and number of OCD symptoms in the clinic. Participants wore a biosensor on their wrist for up to 8 weeks in their everyday lives. Patients were asked to press an event tag button on the biosensor when they were stressed by OCD symptoms. Participants without a psychiatric diagnosis were asked to press this button whenever they felt really scared. Before and after the 8-week observation period, participants wore the biosensor under controlled conditions of rest and stress in the clinic. Features are extracted from 4 different physiological signals within sliding windows to predict the distress event logged by participants during data collection. We will test the prediction models within participants across time and multiple participants. Model selection and estimation using 2-layer cross-validation are outlined for both scenarios.

Results
Participants were included between December 2021 and December 2022. Participants included 10 female and 8 male participants with an even sex distribution between groups. Patients were aged between 10 and 16 years, and adolescents without a psychiatric diagnosis were between the ages of 8 and 16 years. Most patients had moderate to moderate to severe OCD, except for 1 patient with mild OCD.

Conclusions
The strength of the planned study is the investigation of predictions of OCD events in the wild. Major challenges of the study are the inherent noise of in-the-wild data and the lack of contextual knowledge associated with the recorded signals. This preregistered analysis plan discusses in detail how we plan to address these challenges and may help reduce interpretation bias of the upcoming results. If the obtained results from this study are promising, we will be closer to automated detection of OCD events outside of clinical experiments. This is an important tool for the assessment and treatment of OCD in youth.

Trial Registration
ClinicalTrials.gov NCT05064527; https://clinicaltrials.gov/study/NCT05064527

International Registered Report Identifier (IRRID)
DERR1-10.2196/48571