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

Dartmouth Health

Status: Not yet enrolling

Conditions: Major Depressive Disorder; Depression

Treatments: Other: MoodTriggers Application

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07174557

5UM1TR004772-02 (U.S. NIH Grant/Contract)

STUDY00033020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 3 patient groups

Phase 1: Sensing System Calibration (N = 120)

Experimental group

Description:

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.

Treatment:

Other: MoodTriggers Application

Phase 2: Early warning system (n = 100)

Active Comparator group

Description:

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.

Treatment:

Other: MoodTriggers Application

Phase 2: Usual Care (n = 100)

No Intervention group

Description:

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.