Remote Evaluation and Alerting for Collaborative Health (REACH) in Depression

NCT ID: NCT07174557

Last Updated: 2025-12-17

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-11-01

Brief Summary

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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

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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

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Depression Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type EXPERIMENTAL

MoodTriggers Application

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

MoodTriggers Application

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* Identified as high risk due to active suicidality, psychosis, or bipolar disorder - Discharged from CoCM with ongoing depressive symptoms (PhQ-9 \> 10
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Nicholas C. Jacobson

Principal Investigator

Responsibility Role 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

Site Status

Dartmouth-Hitchcock Clinics

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Central Contacts

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Nicholas C Jacobson, PhD

Role: CONTACT

(603) 646-7037

Facility Contacts

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Nicholas C Jacobson, PhD

Role: primary

(603) 646-7037

Nicholas C Jacobson, PhD

Role: primary

(603) 646-7037

Other Identifiers

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5UM1TR004772-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00033020

Identifier Type: -

Identifier Source: org_study_id