Mental Health SymptomsNCT05753605
My Experiences: Leveraging Digital Technologies to Better Understand Mental Health
An observational study of Mental Health Symptoms and Wearables, run by 4YouandMe at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Symptoms, Wearables
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2023to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: We will employ a multisite recruitment. The primary recruitment site will include students attending undergraduate and graduate programs from all 3 School of Nursing campuses at the University of Washington (Seattle, Tacoma and Bothell) from a total student body of 1026 students. The advantage of this specific population is its diversity. According to the UW 2021 census, 63% of this student body reflect Black Indigenous People of Color (BIPOC) or Underrepresented Minorities (URM). Additional sites may include other academic sites in addition to recruitment channels through social media campaigns and student organizations.
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Mental Health Symptoms, Wearables
- Keywords
- Mental Health, Depression, Anxiety, Bipolar Disorder, Psychosis, Wearables
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders, Bipolar Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oura Ring Arm | Participant will be provisioned an Oura smartring. | |
| BYOD (Bring Your Own Device) Arm | Participant will use their personal wearable. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Adherence (daily app survey)
Proportion of participants completing the app daily survey 70% of active study time.
Measured: 3-9 months
Study Adherence (weekly symptom survey)
Proportion of participants completing the app weekly symptom survey 70% of active study time
Measured: 3-9 months
Study Adherence (Wearable device)
Average Oura ring usage over active study follow-up
Measured: 3-9 months
Secondary outcomes (1)
Sensor data relationships with active measurements of mental health (exploratory)
Correlations between objective sensor data with active measurements of mental health symptoms
Measured: 3-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start26 Jun 2023
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4YouandMe
- Sponsor type
- University, hospital or other
- Collaborators
- Definium Therapeutics US, Inc., Vector Institute for Artificial Intelligence, Cambridge Cognition Ltd, University of Washington
- Responsible party
- Sponsor
- Investigators
- Sarah Goodday, PhD, Principal investigator, 4YouandMe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753605
- Sponsor's protocol ID
- 4UMYEXP01
- Status last verified
- Sep 2025
- First submitted
- 20 Jul 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Under the 4YouandMe open source model, we will make all data, findings, and algorithms available in the public domain. Accordingly, coded data produced from this project will be shared broadly with qualified researchers through Sage Bionetworks Synapse. Only data from consenting participants will be shared through Sage Bionetworks Synapse. During study follow-up, internal researchers (4YouandMe, MindMed) will have access to all coded study data for interim analyses. The study app will be owned by MindMed and will not be placed into the public domain, but will be available to be licensed. During study follow-up, internal researchers (4YouandMe, MindMed) will have access to coded data for interim analyses. Coalition partners (Vector Institute, CamCog) will have access to coded study data on a x (TBD) basis during study follow-up. MindMed will provide a compute-space where coded data can be securely accessed by internal researchers and coalition partners (TBD).
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Experiences: Leveraging Digital Technologies to Better Understand Mental Health
- ClinicalTrials.gov ID
- NCT05753605
- Acronym / sponsor ID
- 4UMYEXP01
- Conditions
- Mental Health Symptoms, Wearables
- Keywords
- Mental Health, Depression, Anxiety, Bipolar Disorder, Psychosis, Wearables
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- 4YouandMeUniversity, hospital or other
- Collaborators
- Definium Therapeutics US, Inc., Vector Institute for Artificial Intelligence, Cambridge Cognition Ltd, University of Washington
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oura Ring Arm | – | –Participant will be provisioned an Oura smartring. |
| BYOD (Bring Your Own Device) Arm | – | –Participant will use their personal wearable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We will employ a multisite recruitment. The primary recruitment site will include students attending undergraduate and graduate programs from all 3 School of Nursing campuses at the University of Washington (Seattle, Tacoma and Bothell) from a total student body of 1026 students. The advantage of this specific population is its diversity. According to the UW 2021 census, 63% of this student body reflect Black Indigenous People of Color (BIPOC) or Underrepresented Minorities (URM). Additional sites may include other academic sites in addition to recruitment channels through social media campaigns and student organizations.
Key inclusion criteria (10 listed)
- 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.
- 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.
Key exclusion criteria (7 listed)
- Not willing to permit access to wearable device data or use the study smartphone applications
- Currently or attempting to get pregnant
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study Adherence (daily app survey)
Time frame: 3-9 months
Proportion of participants completing the app daily survey 70% of active study time.
Study Adherence (weekly symptom survey)
Time frame: 3-9 months
Proportion of participants completing the app weekly symptom survey 70% of active study time
Study Adherence (Wearable device)
Time frame: 3-9 months
Average Oura ring usage over active study follow-up
1 secondary outcome
Sensor data relationships with active measurements of mental health (exploratory)
Time frame: 3-9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Yes. Under the 4YouandMe open source model, we will make all data, findings, and algorithms available in the public domain. Accordingly, coded data produced from this project will be shared broadly with qualified researchers through Sage Bionetworks Synapse. Only data from consenting participants will be shared through Sage Bionetworks Synapse. During study follow-up, internal researchers (4YouandMe, MindMed) will have access to all coded study data for interim analyses. The study app will be owned by MindMed and will not be placed into the public domain, but will be available to be licensed. During study follow-up, internal researchers (4YouandMe, MindMed) will have access to coded data for interim analyses. Coalition partners (Vector Institute, CamCog) will have access to coded study data on a x (TBD) basis during study follow-up. MindMed will provide a compute-space where coded data can be securely accessed by internal researchers and coalition partners (TBD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Goodday, PhD principal investigator
4YouandMe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Symptoms and Wearables, run by 4YouandMe at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Adherence (daily app survey) (time frame: 3-9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.