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

NCT07174557 | Not Yet Recruiting

• 2 other identifiers: STUDY000330205UM1TR004772-02
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Depression; Major Depressive Disorder

Keywords

Depression; Smartphone monitoring; Risk detection; Collaborative care

Outcome Measures

Primary Outcomes (1)

• 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.

  discharge, 6-months post-discharge

Secondary Outcomes (1)

• Perceived benefits and barriers of depression monitoring using passive sensing data collected from mobile phones

  0-6 months post-discharge

Study Arms (3)

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.

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.

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.

Interventions

MoodTriggers Application 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 1: Sensing System Calibration (N = 120); Phase 2: Early warning system (n = 100)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (2)

Dartmouth College

Hanover, New Hampshire, 03755, United States

Location

Dartmouth-Hitchcock Clinics

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Nicholas C Jacobson, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas C Jacobson, PhD

CONTACT

(603) 646-7037; nicholas.c.jacobson@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)