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OpenTrials
Completed

NCT Number: NCT05753605

My Experiences: Leveraging Digital Technologies to Better Understand Mental Health

Mental health disorders are one of the most challenging chronic conditions to identify, treat and manage. This is largely due to the fact that diagnoses are almost entirely based on the patient's recall of current and past subjective experiences of symptoms; and then further interpreted by a healthcare professional introducing multiple layers of information biases in the formulation of a diagnosis. Accordingly, mental health conditions remain prevalent with high rates of misdiagnosis, inappropriate treatment and delayed intervention. In light of the heterogeneity across and within mental health conditions, a personalized interventional approach holds merit, yet the tools to effectively track an individual's day to day objective and subjective experience needed to achieve an individualized care approach have not until recently existed.

Digital technologies such as passive and active sensing from smartphones and from wearable devices are shedding light on the capabilities of tracking new objective measures of health that could translate to key symptoms of mental health conditions. 'Multimodal data' approaches are those that attempt to translate a variety of electrical signals from digital devices to relevant health outcomes. The combination of digital devices to detect multimodal measures of mental health symptoms offers a unique opportunity to take a ground up approach in understanding the fluidity of mental health symptoms occurring at the individual level that might lend insight into new phenotypes of mental health illnesses that could have a physiological underpinning.

The Study Investigators aim to characterize the multiplexing and fluid nature of mental health symptoms across individuals experiencing mental health symptoms and conditions using digital tools (i.e., wearables and mobile apps) and additional context information collected from virtual study support calls.

The Investigators hope to know how objective measures from sensor data translate to core symptoms, episodes and flares across mental health disorders, and develop new (or new applications of) machine learning anomaly detection approaches and determine whether anomalies in expected symptom portraits can be reliably detected and enhanced by the addition of objectively measured data.

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Key information

Conditions

Mental Health Symptoms Anxiety Disorders Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders Mood Disorders Personal Satisfaction Psychological Well-Being Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Wearables

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

4YouandMe

Seattle, Washington, 98121, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18+ years of age
  • Experiencing mental health symptoms associated with one or more mental health conditions including major depression, bipolar disorder, anxiety disorder or schizophrenia as defined by cut off scores on validated screening instruments OR a self-reported clinician confirmed diagnosis of a major mood disorder, anxiety disorder or psychotic spectrum disorder at baseline.
  • Major depression (Patient Health Questionnaire (PHQ-9)): total score 10+
  • Bipolar disorder (Mood Disorder Questionnaire (MDQ)): yes to 6+ items on question 1
  • Anxiety disorder (Generalized Anxiety Disorder Scale (GADS-7)): Total score 10+
  • Psychotic spectrum (Prodromal Questionnaire - Brief version (PQ-B)): a cut-off of 6+ endorsed positive items and 6+ for the distress subscale total score
  • Able to speak, write and read English, given the app will be available only in English
  • Able to provide informed consent
  • Participants must have a personally owned iPhone 5s or newer (iOS 12 or higher) and use their phone for this study. This includes a willingness to download and use the study applications and sync their phone with the necessary study devices.
  • Willingness to continuously wear a personally owned wearable device and permit researcher access to pre-identified streams of data (BYOD arm only) Willingness to continuously wear the Oura smartring and permit research access to its data (Oura arm only)

Exclusion criteria

  • Not willing to permit access to wearable device data or use the study smartphone applications
  • Currently or attempting to get pregnant

Cortisol Sub-arm Inclusion Criteria:

For participants interested in the hair cortisol sub-arm, they will have to meet the following inclusion criteria:

  • Willing to extract 50-60 hairs from the back of the head
  • Hair at least 6 centimeters long
  • Not currently taking glucocorticoid containing medication (e.g., beclomethasone, betamethasone, budesonide, cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, triamcinolone)

Treatment and study plan

Primary outcomes

  1. Study Adherence (daily app survey)

    Time frame: 3-9 months

    Proportion of participants completing the app daily survey 70% of active study time.

  2. Study Adherence (weekly symptom survey)

    Time frame: 3-9 months

    Proportion of participants completing the app weekly symptom survey 70% of active study time

  3. Study Adherence (Wearable device)

    Time frame: 3-9 months

    Average Oura ring usage over active study follow-up

Secondary outcomes

  1. Sensor data relationships with active measurements of mental health (exploratory)

    Time frame: 3-9 months

    Correlations between objective sensor data with active measurements of mental health symptoms

Sponsors and collaborators

Lead sponsor

4YouandMe

Other

Collaborators

  • Cambridge Cognition Ltd
  • Definium Therapeutics US, Inc.
  • University of Washington
  • Vector Institute for Artificial Intelligence

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2023
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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