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OpenTrials
Completed

NCT Number: NCT02499094

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral-data driven support

Other

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 outcomes

  1. Change in depression symptom severity

    Time frame: 6 months

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

Secondary outcomes

  1. Change in patient activation

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Ginger.io

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
First posted
Jul 15, 2015
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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