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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02499094

Enrollment

1004

Registered

2015-07-15

Start date

2014-12-31

Completion date

Unknown

Last updated

2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

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.

Interventions

OTHERBehavioral-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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026