NCT07174557

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

Beyond the Clinic: Enhancing Depression Surveillance With a Digital Biomarker

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2029-11-01
• Completion: 2029-11-01
• First posted: 2025-09-16
• Last updated: 2025-12-17

Locations

2 sites across 1 country: United States