Smartphone data may predict depression relapse before it happens
NCT ID NCT07151846
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study is testing whether data from smartphones and wearable devices can predict when a person with depression or bipolar disorder might have another episode. Over 12 months, 540 participants will wear a Fitbit, log daily moods, and complete five check-ins. Researchers will use this data to build AI models that could one day warn of an upcoming relapse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a way to predict when someone with depression or bipolar disorder might have a relapse, allowing for earlier help.
- What could go wrong
- This is an early-stage observational study, not a treatment trial. The digital models may not be accurate enough to predict real-world relapses, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 540 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will recruit a total of 540 participants divided into three groups: Patient Group (PT, n=200): Individuals diagnosed with a mood disorder (bipolar I/II or major depressive disorder) who have experienced at least one depressive episode within the past two years. High-Risk Group (HR): Individuals with no formal mood disorder diagnosis but who present subclinical mood symptoms or elevated screening scores suggesting potential risk for affective disorders. Healthy Control Group (HC): Individuals with no history or current diagnosis of any mood disorder and who do not show clinically significant symptoms on screening assessments. All participants will undergo 5 clinical assessments over a 12-month period (every 3 months) and will be asked to wear a Fitbit device daily and record their mood daily via a mobile app throughout the study. No therapeutic intervention will be provided, and the study does not involve randomization or blinding.
- Ages
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19 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for Patient Group: 1. Adults aged 19 to 75 years and 11 months. 2. Diagnosed with a major mood disorder (bipolar I or II disorder, or major depressive disorder) based on DSM-5, with a history of psychiatric visits for mood symptoms. 3. Has experienced at least one prior depressive episode (major, minor, or brief). 4. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period. Inclusion Criteria for Healthy Control Group: 1. Adults aged 19 to 75 years and 11 months. 2. No current or past diagnosis of bipolar disorder or major depressive disorder. 3. Scores below clinical thresholds on both K-MDQ (\<7) and PHQ-9 (\<5) at baseline assessment. 4. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period. Inclusion Criteria for Hight Risk Group: 1. Adults aged 19 to 75 years and 11 months. 2. No current or past diagnosis of bipolar disorder or major depressive disorder. 3. Meets either of the following: A. Scores above the threshold on K-MDQ (≥7) or PHQ-9 (≥5) at baseline. B. Reports persistent mood symptoms during MINI (e.g., ≥2 weeks of depressive mood/anhedonia, or several days of elevated/irritable mood). 4. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period. Exclusion Critera (Overall) 1. Inability to provide informed consent due to cognitive impairment, severe psychiatric symptoms, or language barriers. 2. Presence of any neurological or medical condition that may significantly affect mood, cognition, or behavior (e.g., epilepsy, dementia, traumatic brain injury). 3. Current substance use disorder or dependence (excluding nicotine or caffeine) that is either untreated or clinically unstable. 4. Severe suicidal ideation or risk as determined by clinical judgment at screening. 5. Ongoing participation in another interventional clinical trial, particularly those involving psychotropic medications or digital health interventions. 6. Inability or unwillingness to wear a wearable device (Fitbit) or use the required mobile application daily throughout the study. 7. Lack of stable internet access or a compatible smartphone required for digital phenotyping data collection. 8. Any other condition that, in the investigator's judgment, may compromise the participant's safety, compliance, or the integrity of the study data.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Korea University Anam Hospital
Seoul, Seongbuk-gu, 02841, South Korea
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