Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 20, 2020
Date Accepted: Jun 25, 2020
Date Submitted to PubMed: Jul 8, 2020
Toi Même: A mHealth Platform for Measuring Bipolar Illness Activity – Feasibility Study Protocol
ABSTRACT
Background:
Diagnosis and management of bipolar disorder (BD) are limited by the absence of available biomarkers. Patients with BD frequently present mood instability, even during remission, likely associated with risk of relapse, impaired functioning, and suicidal behavior, indicating that the illness is active.
Objective:
This research protocol aimed to investigate correlations between clinically rated mood symptoms and mood/behavioral data automatically collected using the Toi Même app in BD patients presenting with different mood episodes. This study also aimed to assess the feasibility of this app for self-monitoring subjective and objective mood/behavior parameters in those patients.
Methods:
This open label, nonrandomized trial will enroll 93 (31 depressive, 31 euthymic, and 31 hypo-manic) adult individuals diagnosed with BD type I/II (DSM-5 criteria), and owning an iPhone. Clinical evaluations will be performed by psychiatrists at the baseline, 2-weeks, 1-month, 2-months and 3-months study follow-up. Rather than only accessing daily mood symptoms, the Toi Même app also integrates ecological momentary assessments through i) Two gamified tests to assess cognition speed (Quickbrain) and affective responses (Playimotions) in real life contexts; ii) Continuous measurements of daily motor activities (e.g. number of steps, distance) using the smartphone’s motion sensors, and iii) A comprehensive weekly assessment, including validated self-rating scales.
Results:
Recruitment began in April 2018 and the completion of the study is estimated in December, 2021. As of April 2019, 25 participants were enrolled in the study. The first results are expected to be submitted for publication throughout 2020.
Conclusions:
Study results will add to the evidence of exploring other alternatives towards a more integrative approach in BD, including digital phenotyping, to develop an ethical and clinically meaningful framework for investigating, diagnosing, and treating individuals at-risk of or suffering from BD. Further prospective studies on the validity of automatically generated smartphone data are needed for better understanding the longitudinal pattern of mood instability in BD as well as to establish the reliability, efficacy, and cost-effectiveness of such an app intervention for BD patients. Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03508427
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