A Wearable Artificial Intelligence Feedback Tool (Wrist Angel) for Treatment and Research of Obsessive Compulsive Disorder: Protocol for a Nonrandomized Pilot Study

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Background: Obsessive compulsive disorder (OCD) in youth is characterized by behaviors, emotions, physiological reactions, and family interaction patterns. An essential component of therapy involves increasing awareness of the links among thoughts, emotions, behaviors, bodily sensations, and family interactions. An automatic assessment tool using physiological signals from a wearable biosensor may enable continuous symptom monitoring inside and outside of the clinic and support cognitive behavioral therapy for OCD. Objective: The primary aim of this study is to evaluate the feasibility and acceptability of using a wearable biosensor to monitor OCD symptoms. The secondary aim is to explore the feasibility of developing clinical and research tools that can detect and predict OCD-relevant internal states and interpersonal processes with the use of speech and behavioral signals. Methods: Eligibility criteria for the study include children and adolescents between 8 and 17 years of age diagnosed with OCD, controls with no psychiatric diagnoses, and one parent of the participating youths. Youths and parents wear biosensors on their wrists that measure pulse, electrodermal activity, skin temperature, and acceleration. Patients and their parents mark OCD episodes, while control youths and their parents mark youth fear episodes. Continuous, in-the-wild data collection will last for 8 weeks. Controlled experiments designed to link physiological, speech, behavioral, and biochemical signals to mental states are performed at baseline and after 8 weeks. Interpersonal interactions in the experiments are filmed and coded for behavior. The films are also processed with computer vision and for speech signals. Participants complete clinical interviews and questionnaires at baseline, and at weeks 4, 7, and 8. Feasibility criteria were set for recruitment, retention, biosensor functionality and acceptability, adherence to wearing the biosensor, and safety related to the biosensor. As a first step in learning the associations between signals and OCD-related parameters, we will use paired t tests and mixed effects models with repeated measures to assess associations between oxytocin, individual biosignal features, and outcomes such as stress-rest and case-control comparisons. Results: The first participant was enrolled on December 3, 2021, and recruitment closed on December 31, 2022. Nine patient dyads and nine control dyads were recruited. Sixteen participating dyads completed follow-up assessments. Conclusions: The results of this study will provide preliminary evidence for the extent to which a wearable biosensor that collects physiological signals can be used to monitor OCD severity and events in youths. If we find the study to be feasible, further studies will be conducted to integrate biosensor signals output into machine learning algorithms that can provide patients, parents, and therapists with actionable insights into OCD symptoms and treatment progress. Future definitive studies will be tasked with testing the accuracy of machine learning models to detect and predict OCD episodes and classify clinical severity.

OriginalsprogEngelsk
Artikelnummere45123
TidsskriftJMIR Research Protocols
Vol/bind12
Antal sider16
ISSN1929-0748
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
This study is funded by the Novo Nordisk Foundation (grant number NNF19OC0056795). We would like to thank the colleagues that supported this work. AR Cecilie Mora-Jensen critically reviewed this protocol. Camilla Uhre critically reviewed the full protocol to the ethics committee. Michella Heinrichsen helped obtain the data protection and collaboration agreements. Julie Hagstrøm and Klara Sofie Vangstrup Halberg reviewed the guided exposure material. Melanie Ritter helped to set-up questionnaires in the Research Electronic Data Capture (REDCap) system and translate questionnaires into Danish. Nicklas Leander Lund helped translate and prepare participant material. We would also like to thank Eli R Lebowitz, Jakob E Bardram, and Niklas Rye Jørgensen for supporting our grant application with letters of support and commitment to collaboration in terms of interpreting results, creating a mobile app for data collection, and analysis of saliva samples, respectively.

Publisher Copyright:
©Nicole Nadine Lønfeldt, Line Katrine Harder Clemmensen, Anne Katrine Pagsberg.

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