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

Primary Purpose

Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavioral-data driven support
Sponsored by
Ginger.io
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Intervention A- Heuristic based

    Intervention B- Machine Learning Based

    Control

    Arm Description

    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

    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

    No intervention

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 14, 2015
    Last Updated
    July 14, 2015
    Sponsor
    Ginger.io
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02499094
    Brief Title
    Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder
    Official Title
    Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder: Protocol for a Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ginger.io

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depressive Disorder

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1004 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention A- Heuristic based
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Intervention B- Machine Learning Based
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Intervention Type
    Other
    Intervention Name(s)
    Behavioral-data driven support
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Change in depression symptom severity
    Description
    Change in the 9-item Patient Health Questionnaire (PHQ-9) score from baseline
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Change in patient activation
    Description
    Change in the 13-item Patient Activation Measure score from baseline
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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