NCT02499094

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,004

participants targeted

Target at P75+ for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

July 14, 2015

Last Update Submit

July 14, 2015

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in depression symptom severity

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

    6 months

Secondary Outcomes (1)

  • Change in patient activation

    6 months

Study Arms (3)

Intervention A- Heuristic based

EXPERIMENTAL

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

Other: Behavioral-data driven support

Intervention B- Machine Learning Based

EXPERIMENTAL

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

Other: Behavioral-data driven support

Control

NO INTERVENTION

No intervention

Interventions

Behavioral-data driven supportOTHER

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)

Intervention A- Heuristic basedIntervention B- Machine Learning Based

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Data Scientist

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 15, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2015

Last Updated

July 15, 2015

Record last verified: 2015-07