Remote Evaluation and Alerting for Collaborative Health (REACH) in Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MoodTriggers Application.
- Who it may be relevant to
- Registry conditions: Depression, Major Depressive Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Beyond the Clinic: Enhancing Depression Surveillance With a Digital Biomarker
Overview
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.
Interventions
- 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 rat
Primary outcome measures
- Monthly depression relapse [Time frame: discharge, 6-months post-discharge]
Secondary outcome measures (1)
- Perceived benefits and barriers of depression monitoring using passive sensing data collected from mobile phones [Time frame: 0-6 months post-discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Dartmouth College — Hanover
- Dartmouth-Hitchcock Clinics — Lebanon
Identifiers
NCT: NCT07174557 · STUDY00033020 · 5UM1TR004772-02