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

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder
• Intervention / Treatment: Other: Behavioral-data driven support

Detailed Description

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
• Enrollment (Actual): 1004
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: Intervention A- Heuristic based; 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; 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)
Experimental: Intervention B- Machine Learning Based; 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; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ginger.io

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 14, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: GIO-001