Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-01 @ 1:44 PM
Study NCT ID:
NCT02499094
Status:
COMPLETED
Last Update Posted:
2015-07-15
First Post:
2015-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder
Sponsor:
Ginger.io
Organization:
Study Overview
Official Title:
Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder: Protocol for a Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: