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

ConditionsDepression Major Depressive Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorDartmouth-Hitchcock Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

MoodTriggers Application
Other intervention
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.

Treatment groups

320 Participants

are divided into 3 treatment groups

Group A: Phase 1: Sensing System Calibration (N = 120)Experimental treatment 1 intervention

Group B: Phase 2: Early warning system (n = 100)Active comparator 1 intervention

Group C: Phase 2: Usual Care (n = 100)No intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

discharge, 6-months post-discharge

Secondary outcomes

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

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.

Time frame

0-6 months post-discharge

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Source ClinicalTrials.gov

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