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

Not Applicable

Not yet recruiting

• Conditions: Depression; Major Depressive Disorder

• Registration Number: NCT07174557
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

Researchers hope to see if the data smartphones collect continuously can be used to predict if your depression symptoms will return. They will do this by collecting data from your smartphone and comparing it to your depression symptoms. If this method is successful, researchers could develop a smartphone application to help your healthcare providers better monitor your depression and intervene earlier if symptoms return.

Detailed Description

Study phase 1: The investigators expect that you 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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-11-01
• Primary Completion: 2029-11-01
• Study Completion: 2029-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Monthly depression relapse	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 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.

Secondary Outcome Measures

Name	Time	Method
Perceived benefits and barriers of depression monitoring using passive sensing data collected from mobile phones	0-6 months post-discharge	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.

Trial Locations

Locations (2)

Dartmouth College; 🇺🇸 Hanover, New Hampshire, United States

Dartmouth-Hitchcock Clinics; 🇺🇸 Lebanon, New Hampshire, United States