DepressionNCT07174557
Remote Evaluation and Alerting for Collaborative Health (REACH) in Depression
A study testing MoodTriggers Application in people with Depression and Major Depressive Disorder, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
Researchers hope to see if the data smartphones collect continuously can be used to predict if patient's depression symptoms will return. They will do this by collecting data from patient's smartphones and comparing it to their depression symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Major Depressive Disorder
- What is being tested?
- MoodTriggers Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2026to 30 Jun 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years or older)
- Treated for depression within Dartmouth Health collaborative care model (CoCM) sites who are discharged from CoCM without depression (PHQ-9 < 10)
- Have access to and ability to use a smartphone (Android version ≥ 6 or iOS version ≥ 11).
Who cannot join
- Identified as high risk due to active suicidality, psychosis, or bipolar disorder - Discharged from CoCM with ongoing depressive symptoms (PhQ-9 > 10
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dartmouth College
Hanover, New Hampshire, 03755
Nicholas C Jacobson, PhD, (603) 646-7037, nicholas.c.jacobson@dartmouth.edu
- Recruiting
Dartmouth-Hitchcock Clinics
Lebanon, New Hampshire, 03766
Nicholas C Jacobson, PhD, (603) 646-7037, nicholas.c.jacobson@dartmouth.edu
About this study
Official title: Beyond the Clinic: Enhancing Depression Surveillance With a Digital Biomarker
Researchers hope to see if the data smartphones collect continuously can be used to predict if patient's depression symptoms will return. They will do this by collecting data from patient's smartphones and comparing it to their depression symptoms. If this method is successful, researchers could develop a smartphone application to help healthcare providers better monitor patient's depression and intervene earlier if symptoms return.
Read the detailed description
Study phase 1: The investigators expect that participants will be in this research study for six months. Participants will be asked to download an app on their smartphone. This app will collect data from the phone's sensors. Participants will also be asked to answer some questions about their mood each month.
Study phase 2: This phase of the study is randomized which means that in order to learn about the effect of the Smartphone App, half the people in this study will use it, and the other half will not. If participants decide to enroll into this research study, they will be assigned by chance to one of the following groups:
Group A: Participants will be asked to download a Smartphone App. This App will collect data from the phone's sensors.
Group B: Participants will have usual care. Both Groups: Participants will be asked to complete questionnaires about their mood each month.
- Conditions
- Depression, Major Depressive Disorder
- Being tested
- MoodTriggers Application
- Keywords
- Depression, Smartphone monitoring, Risk detection, Collaborative care
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoodTriggers ApplicationOther
The Mood Triggers application, developed by Dr. Jacobson, will be used for collecting smartphone sensor data. This HIPAA-compliant app has been incorporated into various projects at Dartmouth, Stanford, and MGH/Harvard, with development supported by NIDA, NIMHD, NCI, and the Department of Veterans Affairs. The Mood Triggers app will capture a wide range of metrics, including psychomotor agitation, sleep disturbances, low behavioral activation, social contact, exposure to natural light, heart rate, heart rate variability, and screen time. The app also tracks the patient's screen time and app usage data. The Mood Triggers App will be installed on the smartphones at time of informed consent for all 120 patients enrolled in Phase 1 and for 100 clinical trial participants randomized to the "early warning system" (intervention arm) in Phase 2. Data will be collected from the Mood Triggers App starting on day of discharge from care and for 6 months post-discharge date.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Sensing System Calibration (N = 120) | Experimental | We expect that participants will be in this research study for six months. Participants will be asked to download an app on their smartphone. This app will collect data from the phone's sensors. Participants will also be asked to answer some questions about their mood each month. Receives: Other: MoodTriggers Application |
| Phase 2: Early warning system (n = 100) | Active comparator | This study is randomized which means that in order to learn about the effect of the Smartphone App, half the people in this study will use it, and the other half will not. If participants decide to enroll into this research study, they may be assigned by chance to download a Smartphone App. This App will collect data from the phone's sensors. Participants will also be asked to complete questionnaires about their mood each month. Receives: Other: MoodTriggers Application |
| Phase 2: Usual Care (n = 100) | No intervention | This study is randomized which means that in order to learn about the effect of the Smartphone App, half the people in this study will use it, and the other half will not. If participants decide to enroll into this research study, they may be assigned by chance to have usual care. Participants will be asked to complete questionnaires about their mood each month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly depression relapse
The 9-item Patient Health Questionnaire (PHQ-9), a validated self-reported depression questionnaire, will be used to detect monthly depression recurrence based on past-month MoodTriggers application data. The PHQ-9 scores range from 0-27, with higher scores reflecting higher depression symptom levels. The PHQ-9 will be used to detect monthly recurrence of Major Depressive Disorder (MDD; PHQ-9 scores ≥ 10) during Phase 1 in all 120 participants. For the randomized clinical trial in Phase 2, we will capture the PHQ-9 monthly in both arms (MoodTriggers app vs. no app) for 6-months following discharge.
Measured: discharge, 6-months post-discharge
Secondary outcomes (1)
Perceived benefits and barriers of depression monitoring using passive sensing data collected from mobile phones
A subgroup of individuals from Phase 1 will be invited and verbally consented to participate in semi-structured interviews to provide their experiences with the study's digital biomarker "early warning" system. The purpose of this interview is to identify perceived benefits and barriers of depression monitoring using passive sensing data collection from your mobile phone. The information gathered will be used to evaluate the effectiveness of the Mood Trigger app in predicting symptoms of depression.
Measured: 0-6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start20 May 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Nicholas C. Jacobson, Dartmouth-Hitchcock Medical Center
- Investigators
- Nicholas C Jacobson, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174557
- Sponsor's protocol ID
- STUDY00033020
- Other IDs
- 5UM1TR004772-02
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond the Clinic: Enhancing Depression Surveillance With a Digital Biomarker
- ClinicalTrials.gov ID
- NCT07174557
- Acronym / sponsor ID
- STUDY00033020
- Conditions
- Depression, Major Depressive Disorder
- Keywords
- Depression, Smartphone monitoring, Risk detection, Collaborative care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 20 May 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 16 Sep 2025 (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.
Researchers hope to see if the data smartphones collect continuously can be used to predict if patient's depression symptoms will return. They will do this by collecting data from patient's smartphones and comparing it to their depression symptoms. If this method is successful, researchers could develop a smartphone application to help healthcare providers better monitor patient's depression and intervene earlier if symptoms return.
Detailed description
Study phase 1: The investigators expect that participants will be in this research study for six months. Participants will be asked to download an app on their smartphone. This app will collect data from the phone's sensors. Participants will also be asked to answer some questions about their mood each month.
Study phase 2: This phase of the study is randomized which means that in order to learn about the effect of the Smartphone App, half the people in this study will use it, and the other half will not. If participants decide to enroll into this research study, they will be assigned by chance to one of the following groups:
Group A: Participants will be asked to download a Smartphone App. This App will collect data from the phone's sensors.
Group B: Participants will have usual care. Both Groups: Participants will be asked to complete questionnaires about their mood each month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Sensing System Calibration (N = 120) | Experimental | Other: MoodTriggers ApplicationWe expect that participants will be in this research study for six months. Participants will be asked to download an app on their smartphone. This app will collect data from the phone's sensors. Participants will also be asked to answer some questions about their mood each month. |
| Phase 2: Early warning system (n = 100) | Active comparator | Other: MoodTriggers ApplicationThis study is randomized which means that in order to learn about the effect of the Smartphone App, half the people in this study will use it, and the other half will not. If participants decide to enroll into this research study, they may be assigned by chance to download a Smartphone App. This App will collect data from the phone's sensors. Participants will also be asked to complete questionnaires about their mood each month. |
| Phase 2: Usual Care (n = 100) | No intervention | –This study is randomized which means that in order to learn about the effect of the Smartphone App, half the people in this study will use it, and the other half will not. If participants decide to enroll into this research study, they may be assigned by chance to have usual care. Participants will be asked to complete questionnaires about their mood each month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18 years or older)
- Treated for depression within Dartmouth Health collaborative care model (CoCM) sites who are discharged from CoCM without depression (PHQ-9 < 10)
- Have access to and ability to use a smartphone (Android version ≥ 6 or iOS version ≥ 11).
Key exclusion criteria (1 listed)
- Identified as high risk due to active suicidality, psychosis, or bipolar disorder - Discharged from CoCM with ongoing depressive symptoms (PhQ-9 > 10
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 |
|---|---|---|
| MoodTriggers ApplicationThe Mood Triggers application, developed by Dr. Jacobson, will be used for collecting smartphone sensor data. This HIPAA-compliant app has been incorporated into various projects at Dartmouth, Stanford, and MGH/Harvard, with development supported by NIDA, NIMHD, NCI, and the Department of Veterans Affairs. The Mood Triggers app will capture a wide range of metrics, including psychomotor agitation, sleep disturbances, low behavioral activation, social contact, exposure to natural light, heart rate, heart rate variability, and screen time. The app also tracks the patient's screen time and app usage data. The Mood Triggers App will be installed on the smartphones at time of informed consent for all 120 patients enrolled in Phase 1 and for 100 clinical trial participants randomized to the "early warning system" (intervention arm) in Phase 2. Data will be collected from the Mood Triggers App starting on day of discharge from care and for 6 months post-discharge date. | Other | Phase 1: Sensing System Calibration (N = 120), Phase 2: Early warning system (n = 100) |
Primary outcome
Monthly depression relapse
Time frame: discharge, 6-months post-discharge
The 9-item Patient Health Questionnaire (PHQ-9), a validated self-reported depression questionnaire, will be used to detect monthly depression recurrence based on past-month MoodTriggers application data. The PHQ-9 scores range from 0-27, with higher scores reflecting higher depression symptom levels. The PHQ-9 will be used to detect monthly recurrence of Major Depressive Disorder (MDD; PHQ-9 scores ≥ 10) during Phase 1 in all 120 participants. For the randomized clinical trial in Phase 2, we will capture the PHQ-9 monthly in both arms (MoodTriggers app vs. no app) for 6-months following discharge.
1 secondary outcome
Perceived benefits and barriers of depression monitoring using passive sensing data collected from mobile phones
Time frame: 0-6 months post-discharge
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 11 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Nicholas C Jacobson, PhD principal investigator
Dartmouth College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoodTriggers Application in people with Depression and Major Depressive Disorder, run by Dartmouth-Hitchcock Medical Center at 2 sites 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Nicholas C Jacobson, PhD ((603) 646-7037, nicholas.c.jacobson@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly depression relapse (time frame: discharge, 6-months post-discharge). 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 11 Aug 2026.