Major Depressive DisorderNCT05767593
Clinical Validation of Samsung Smartwatch
An observational study of Major Depressive Disorder and Mood Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Objective: Wearable technology holds promising potential for mental health monitoring and detection. Samsung has developed an algorithm that they believe can detect signs of depression and anxiety in smartwatch users. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Mood Disorders, Mental Health Issue
- What is being tested?
- Wearing Samsung smartwatch and filling out daily surveys
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: U.S. residents recruited through online advertisements.
Who may be able to join
- Age 18-65
- Meet full DSM-5 diagnostic criteria for a current major depressive episode, as assessed by the MINI for DSM-5 or Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) AND exhibit both:
- Beck Depression Inventory score of 9 or higher.
- Clinical Global Impressions Scale of 3 or higher.
- If the patient is receiving psychopharmacological or psychosocial treatment, must be stable for 8 weeks prior to enrollment.
- Age 18-65
Show all 10Show fewer
- Do not meet the criteria for current or past major depressive episodes according to the DSM-5 criteria AND exhibit both:
- Beck Depression Inventory score of 8 or lower.
- Clinical Global Impressions Scale of 2 or lower.
- If the patient is receiving psychopharmacological or psychosocial treatment, must be stable for 8 weeks prior to enrollment.
Who cannot join
- A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders; an eating disorder in the past 6 months; organic brain syndrome; a history of substance use disorder in the last 12 months.
- Presence or history of clinically significant neurological disorders and brain injuries (cerebral infarction, cerebral hemorrhage, multiple sclerosis, epilepsy, etc.)
- Serious medical illness or instability for which hospitalization may be likely within the next year.
- Patient does not own a smartphone with a data plan that allows them to receive text messages and access the internet throughout the day.
- Patient is unable to understand study procedures and participate in the informed consent process.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Objective:
Wearable technology holds promising potential for mental health monitoring and detection. Samsung has developed an algorithm that they believe can detect signs of depression and anxiety in smartwatch users. They have used this algorithm to create a "Mindfulness Index," which is an easily understood visual index of mental health. The primary aim of the study is to evaluate the performance of Samsung's Mindfulness Index in identifying those who have received a diagnosis of Major Depressive Disorder (MDD) from a clinician-administered semi-structured diagnostic interview.
Read more
Research Procedures:
The target sample size is 135 individuals diagnosed with current Major Depressive Disorder and 85 healthy controls. To meet this target, the recruitment target is set at 220 participants. Participants will be assigned to the MDD condition, or the healthy control condition based on their score on the Beck Depression Inventory. Each subject will be followed for 3 months. Participants will be provided with a Samsung smartphone and Samsung smartwatch. Participants will be asked to wear the smartwatch 24 hours per day, except while charging. This smartwatch will collect data on heartrate, sleep time, and step count. During the study, each day participants will receive texts prompting a link to a "daily diary." These surveys will ask about depression and anxiety symptoms. Additionally, during the first 3 weeks of the study, participants will participate in ecological momentary assessment; texts will be sent 5 times per day prompting participants to fill out a survey about how they currently feel in that moment. These extra surveys will stop after the first 3 weeks of the study, but the daily diary surveys will continue throughout the study. Furthermore, virtual clinician visits will occur at weeks 4, 8, and 12.
- Being tested
- Wearing Samsung smartwatch and filling out daily surveys
- Keywords
- Wearable technology, Smartwatch
- Medical subject headings
- Depressive Disorder, Major, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing Samsung smartwatch and filling out daily surveysDevice
Participants will wear a Samsung smartwatch and fill out daily surveys about their mood and depressive symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Depressed Adults | Adults with a current diagnosis of Major Depressive Episode Receives: Device: Wearing Samsung smartwatch and filling out daily surveys | |
| Healthy Controls | Adults without a current or past diagnosis of Major Depressive Episode Receives: Device: Wearing Samsung smartwatch and filling out daily surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of an index derived from passively collected data in identifying those who have received a diagnosis of Major Depressive Disorder (MDD)
Area under the Receiver-Operating Characteristic curve (AUC) for an index derived from up to 3-months of passively-collected data from a smartwatch device in identifying those diagnosed with major depressive disorder (as assessed by MINI or DIAMOND Diagnostic Interview).
Measured: Up to 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start27 Apr 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Principal investigator, Amanda W. Baker, Ph.D., Massachusetts General Hospital
- Investigators
- Amanda Baker, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767593
- Sponsor's protocol ID
- 2022P002104
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Samsung Smartwatch
- ClinicalTrials.gov ID
- NCT05767593
- Acronym / sponsor ID
- 2022P002104
- Keywords
- Wearable technology, Smartwatch
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 14 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.
Objective:
Wearable technology holds promising potential for mental health monitoring and detection. Samsung has developed an algorithm that they believe can detect signs of depression and anxiety in smartwatch users. They have used this algorithm to create a "Mindfulness Index," which is an easily understood visual index of mental health. The primary aim of the study is to evaluate the performance of Samsung's Mindfulness Index in identifying those who have received a diagnosis of Major Depressive Disorder (MDD) from a clinician-administered semi-structured diagnostic interview.
Research Procedures:
The target sample size is 135 individuals diagnosed with current Major Depressive Disorder and 85 healthy controls. To meet this target, the recruitment target is set at 220 participants. Participants will be assigned to the MDD condition, or the healthy control condition based on their score on the Beck Depression Inventory. Each subject will be followed for 3 months. Participants will be provided with a Samsung smartphone and Samsung smartwatch. Participants will be asked to wear the smartwatch 24 hours per day, except while charging. This smartwatch will collect data on heartrate, sleep time, and step count. During the study, each day participants will receive texts prompting a link to a "daily diary." These surveys will ask about depression and anxiety symptoms. Additionally, during the first 3 weeks of the study, participants will participate in ecological momentary assessment; texts will be sent 5 times per day prompting participants to fill out a survey about how they currently feel in that moment. These extra surveys will stop after the first 3 weeks of the study, but the daily diary surveys will continue throughout the study. Furthermore, virtual clinician visits will occur at weeks 4, 8, and 12.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depressed Adults | – | Device: Wearing Samsung smartwatch and filling out daily surveysAdults with a current diagnosis of Major Depressive Episode |
| Healthy Controls | – | Device: Wearing Samsung smartwatch and filling out daily surveysAdults without a current or past diagnosis of Major Depressive Episode |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- U.S. residents recruited through online advertisements.
Key inclusion criteria (10 listed)
- Age 18-65
- Meet full DSM-5 diagnostic criteria for a current major depressive episode, as assessed by the MINI for DSM-5 or Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) AND exhibit both:
- If the patient is receiving psychopharmacological or psychosocial treatment, must be stable for 8 weeks prior to enrollment.
- Age 18-65
- Do not meet the criteria for current or past major depressive episodes according to the DSM-5 criteria AND exhibit both:
Key exclusion criteria (5 listed)
- A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders; an eating disorder in the past 6 months; organic brain syndrome; a history of substance use disorder in the last 12 months.
- Presence or history of clinically significant neurological disorders and brain injuries (cerebral infarction, cerebral hemorrhage, multiple sclerosis, epilepsy, etc.)
- Serious medical illness or instability for which hospitalization may be likely within the next year.
- Patient does not own a smartphone with a data plan that allows them to receive text messages and access the internet throughout the day.
- Patient is unable to understand study procedures and participate in the informed consent process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearing Samsung smartwatch and filling out daily surveysParticipants will wear a Samsung smartwatch and fill out daily surveys about their mood and depressive symptoms. | Device | Depressed Adults, Healthy Controls |
Primary outcome
Performance of an index derived from passively collected data in identifying those who have received a diagnosis of Major Depressive Disorder (MDD)
Time frame: Up to 3-months
Area under the Receiver-Operating Characteristic curve (AUC) for an index derived from up to 3-months of passively-collected data from a smartwatch device in identifying those diagnosed with major depressive disorder (as assessed by MINI or DIAMOND Diagnostic Interview).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Amanda Baker, PhD principal investigator
Massachusetts General Hospital
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 Major Depressive Disorder and Mood Disorders, run by Massachusetts General Hospital 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 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Performance of an index derived from passively collected data in identifying those who have received a diagnosis of Major Depressive Disorder (MDD) (time frame: Up to 3-months). 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 17 Apr 2026.