Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder

Ginger.io1,004 enrolled

Overview

The purpose of this study is to validate the effectiveness of using an integrated mobile sensing platform to deliver large-scale data-driven interventions to patients with depression.

This study is a smartphone-based, randomized, single-blind, controlled parallel- design study with two intervention arms and one control arm. The two intervention arms will receive in-app messages and phone-based support, which will be triggered by participant's self-reported surveys and passive behavioral data gathered through a smartphone app. The study will include a nationwide sample of adult (18 years or older) smartphone users, who are currently experiencing depressive symptoms. The primary outcome will be decrease in depression symptom severity, as measured by the 9-item Patient Health Questionnaire, over 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

1,004

Conditions

Depressive Disorder

Interventions

Behavioral-data driven supportOTHER

Phone-based support (e.g. triaging of the situation, emotional support, and guidance on next steps for the patient) and in-app support (health education content based on cognitive behavioral therapies, mindfulness, and behavioral activation)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Currently suffering from depression (as measured by a PHQ-9 score of 10 or more at the time of screening) * Own an iPhone or Android smartphone with a mobile voice calling plan with a US carrier * Fluency in English Exclusion Criteria: * Participants with visual or hearing impairment * Recent history of pregnancy (currently pregnant or those who have given birth within the past four months at the time of screening) * Recent loss of a loved one (within the past two months at the time of screening) * Unable or unwilling to accept End User License Agreement, or to provide information regarding their demographic characteristics and mental health history

Outcomes

Primary Outcomes

Change in depression symptom severity

Change in the 9-item Patient Health Questionnaire (PHQ-9) score from baseline

Time frame: 6 months

Secondary Outcomes

Change in patient activation

Change in the 13-item Patient Activation Measure score from baseline

Time frame: 6 months

Data from ClinicalTrials.gov

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