BackgroundCognitive symptoms are common in major depressive disorder and may help to identify patients who need treatment or who are not experiencing adequate treatment response. Digital tools providing real-time data assessing cognitive function could help support patient treatment and remediation of cognitive and mood symptoms.ObjectiveThe aim of this study was to examine feasibility and validity of a wearable high-frequency cognitive and mood assessment app over 6 weeks, corresponding to when antidepressant pharmacotherapy begins to show efficacy.MethodsA total of 30 patients (aged 19-63 years; 19 women) with mild-to-moderate depression participated in the study. The new Cognition Kit app was delivered via the Apple Watch, providing a high-resolution touch screen display for task presentation and logging responses. Cognition was assessed by the n-back task up to 3 times daily and depressed mood by 3 short questions once daily. Adherence was defined as participants completing at least 1 assessment daily. Selected tests sensitive to depression from the Cambridge Neuropsychological Test Automated Battery and validated questionnaires of depression symptom severity were administered on 3 occasions (weeks 1, 3, and 6). Exploratory analyses examined the relationship between mood and cognitive measures acquired in low- and high-frequency assessment.ResultsAdherence was excellent for mood and cognitive assessments (95% and 96%, respectively), did not deteriorate over time, and was not influenced by depression symptom severity or cognitive function at study onset. Analyses examining the relationship between high-frequency cognitive and mood assessment and validated measures showed good correspondence. Daily mood assessments correlated moderately with validated depression questionnaires (r=0.45-0.69 for total daily mood score), and daily cognitive assessments correlated moderately with validated cognitive tests sensitive to depression (r=0.37-0.50 for mean n-back).ConclusionsThis study supports the feasibility and validity of high-frequency assessment of cognition and mood using wearable devices over an extended period in patients with major depressive disorder.

Background Several app-based studies share similar characteristics of a light touch approach that recruit, enroll, and onboard via a smartphone app and attempt to minimize burden through low-friction active study tasks while emphasizing the collection of passive data with minimal human contact. However, engagement is a common challenge across these studies, reporting low retention and adherence. Objective This study aims to describe an alternative to a light touch digital health study that involved a participant-centric design including high friction app-based assessments, semicontinuous passive data from wearable sensors, and a digital engagement strategy centered on providing knowledge and support to participants. Methods The Stress and Recovery in Frontline COVID-19 Health Care Workers Study included US frontline health care workers followed between May and November 2020. The study comprised 3 main components: (1) active and passive assessments of stress and symptoms from a smartphone app, (2) objective measured assessments of acute stress from wearable sensors, and (3) a participant codriven engagement strategy that centered on providing knowledge and support to participants. The daily participant time commitment was an average of 10 to 15 minutes. Retention and adherence are described both quantitatively and qualitatively. Results A total of 365 participants enrolled and started the study, and 81.0% (n=297) of them completed the study for a total study duration of 4 months. Average wearable sensor use was 90.6% days of total study duration. App-based daily, weekly, and every other week surveys were completed on average 69.18%, 68.37%, and 72.86% of the time, respectively. Conclusions This study found evidence for the feasibility and acceptability of a participant-centric digital health study approach that involved building trust with participants and providing support through regular phone check-ins. In addition to high retention and adherence, the collection of large volumes of objective measured data alongside contextual self-reported subjective data was able to be collected, which is often missing from light touch digital health studies. Trial Registration ClinicalTrials.gov NCT04713111; https://clinicaltrials.gov/ct2/show/NCT04713111

The Better Understanding the Metamorphosis of Pregnancy (BUMP) study is a longitudinal feasibility study aimed to gain a deeper understanding of the pre-pregnancy and pregnancy symptom experience using digital tools. The present paper describes the protocol for the BUMP study. Over 1000 participants are being recruited through a patient provider-platform and through other channels in the United States (US). Participants in a preconception cohort (BUMP-C) are followed for 6 months, or until conception, while participants in a pregnancy cohort (BUMP) are followed into their fourth trimester. Participants are provided with a smart ring, a smartwatch (BUMP only), and a smart scale (BUMP only) alongside cohort-specific study apps. Participant centric engagement strategies are used that aim to co-design the digital approach with participants while providing knowledge and support. The BUMP study is intended to lay the foundational work for a larger study to determine whether participant co-designed digital tools can be used to detect, track and return multimodal symptoms during the perinatal window to inform individual level symptom trajectories.

The ability of remote research tools to collect granular, high-frequency data on symptoms and digital biomarkers is an important strength because it circumvents many limitations of traditional clinical trials and improves the ability to capture clinically relevant data. This approach allows researchers to capture more robust baselines and derive novel phenotypes for improved precision in diagnosis and accuracy in outcomes. The process for developing these tools however is complex because data need to be collected at a frequency that is meaningful but not burdensome for the participant or patient. Furthermore, traditional techniques, which rely on fixed conditions to validate assessments, may be inappropriate for validating tools that are designed to capture data under flexible conditions. This paper discusses the process for determining whether a digital assessment is suitable for remote research and offers suggestions on how to validate these novel tools.

Background: Current cognitive and functional assessments of patients with cognitive impairment and dementia have well understood limitations including high test:re-test variability, sparse data collection in clinic environments that may not reflect 'real life' performance, and assessment tools being language, education and culture sensitive. Continuous patient data collection using wearable devices (e.g. wristbands/wristwatches) measuring factors such as activity and sleep, may provide future digital biomarkers that are more sensitive than current approaches especially for assessing function in clinical trials. It is therefore important to evaluate acceptance and tolerability of such devices for patients and caregivers, determine how such continuous data collection may fit with conventional clinical measures, and establish the technical and regulatory requirements for GCP compliance. Methods: We undertook SWOT analyses on: (1)study designs most suited to evaluate the use of wearables for clinical data collection; (2) acceptability and tolerability of a commercially available wearable device [1]; and (3)technical and regulatory challenges in in recording the study data. Using qualitative methods including semi-structured and free discussions, we held focus groups with stakeholder representatives (people with dementia and caregivers; n¼12) to explore these issues. Results: Strengths: prospect of participating in such studies; transfer and storage of data from wearables via mobile devices; and tolerability of such devices for either clinical care or research purposes. Weaknesses: potential for non-adherence with the device, particularly at night; difficulty in putting devices on without help; and loss of connectivity for data collection. The Cygnus project [2] will soon start, and deploy these technologies in a symptomatic, community population with cognitive impairment and their care-givers. Conclusions: The use of wearables for continuous clinical data collection is feasible and potentially tolerated by patients with cognitive impairment and dementia. Data security, authentication and validation challenges remain for GCP compliance but patients did not raise concerns about impact on their privacy. Studies like Cygnus are now needed to evaluate prospectively the tolerability of wearable devices and whether meaningful digital functional biomarkers can be generated from the data; further work is required to establish the regulatory path for such devices providing functional endpoints in clinical trials.[1] Withings Activity Pop [2] Cygnus, Innovate UK Grant no.102159.Background: Clinical and research assessments of cognition, mood and behaviour provide validated snapshots of functioning at specific time points. However, depression and mild cognitive impairment exhibit fluctuations which are challenging to quantify, but impact on quality of life and ability to perform daily tasks. The identification of these fluctuations has the potential to provide ecologically relevant outcomes for clinical research, complementing i...