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

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499094
• Other study ID #: GIO-001
• Status: Completed
• Phase: N/A
• First received: July 14, 2015
• Last updated: July 14, 2015
• Start date: December 2014

Study information

• Verified date: July 2015
• Source: Ginger.io
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1004
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ginger.io

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression symptom severity	Change in the 9-item Patient Health Questionnaire (PHQ-9) score from baseline	6 months	No
Secondary	Change in patient activation	Change in the 13-item Patient Activation Measure score from baseline	6 months	No