Remote Evaluation and Alerting for Collaborative Health (REACH) in Depression
NCT ID: NCT07174557
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
320 participants
INTERVENTIONAL
2026-01-01
2029-11-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Phase 1: Sensing System Calibration (N = 120)
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.
MoodTriggers Application
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.
Phase 2: Early warning system (n = 100)
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.
MoodTriggers Application
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.
Phase 2: Usual Care (n = 100)
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.
No interventions assigned to this group
Interventions
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MoodTriggers Application
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Nicholas C. Jacobson
Principal Investigator
Principal Investigators
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Nicholas C Jacobson, PhD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth College
Locations
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Dartmouth College
Hanover, New Hampshire, United States
Dartmouth-Hitchcock Clinics
Lebanon, New Hampshire, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00033020
Identifier Type: -
Identifier Source: org_study_id