My Experiences: Leveraging Digital Technologies to Better Understand Mental Health

Wearables Clinical Trial

Official title:

My Experiences: Leveraging Digital Technologies to Better Understand Mental Health

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05753605
• Other study ID #: 4UMYEXP01
• Status: Enrolling by invitation
• Start date: June 26, 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: 4YouandMe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mental Health Symptoms
• Wearables

Locations

Country	Name	City	State
United States	4YouandMe	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
4YouandMe	Cambridge Cognition Ltd, Mind Medicine, Inc., University of Washington, Vector Institute for Artificial Intelligence

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Adherence (daily app survey)	Proportion of participants completing the app daily survey 70% of active study time.	3-9 months
Primary	Study Adherence (weekly symptom survey)	Proportion of participants completing the app weekly symptom survey 70% of active study time	3-9 months
Primary	Study Adherence (Wearable device)	Average Oura ring usage over active study follow-up	3-9 months
Secondary	Sensor data relationships with active measurements of mental health (exploratory)	Correlations between objective sensor data with active measurements of mental health symptoms	3-9 months