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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder: Protocol for a Randomized Controlled Study

Conditions
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Depressive Disorder

Intervention / Treatment
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* Other: Behavioral-data driven support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention A- Heuristic based<br>Behavioral-data driven support, both mobile phone application and phone-based, informed by their self-reported symptom assessment as well as simple heuristic-based behavioral measures | Other: Behavioral-data driven support<br>* 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)<br>|
| Experimental: Intervention B- Machine Learning Based<br>Behavioral-data driven support, both mobile phone application and phone-based, informed by their self-reported symptom assessment as well as machine learning model-based behavioral measures | Other: Behavioral-data driven support<br>* 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)<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression symptom severity | Change in the 9-item Patient Health Questionnaire (PHQ-9) score from baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient activation | Change in the 13-item Patient Activation Measure score from baseline | 6 months |