NCT02776839

Brief Summary

The objective of this study is two fold, first to explore the potential of context sensitive intervention delivery to provide in-situ support for people with depressive symptoms, second to explore the detection of daily-life behavior based on smart phone sensor information to identify subjects with a clinically meaningful depression level.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable depression

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
Last Updated

June 2, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

May 9, 2016

Last Update Submit

June 1, 2017

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire - for depression (PHQ-9)

    subjective depressive symptoms to compare the detected symptoms measured by the app This outcome is needed for the sensing part of the study

    baseline

Secondary Outcomes (1)

  • Client Satisfaction Questionnaire (ZUF-8)- measures client satisfaction with the app

    at post (at least 6 weeks after baseline) however some participants will use the app longer than 6 weeks, maximum 6 months

Other Outcomes (1)

  • Patient Health Questionnaire - for depression (PHQ-9) change

    baseline and every other week for at least 6 weeks up to 6 months

Study Arms (1)

Mobile Sensing

OTHER

This phase of the study is designed to develop the app. due to algorithms the app should lern to detect depressive symptoms

Device: Mobile sensing

Interventions

Mobile sensingDEVICE
Also known as: Mobile app
Mobile Sensing

Eligibility Criteria

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

You may qualify if:

  • self-declaration of depressive symptoms
  • app runs on Android 4.0 and higher
  • germen speaking

You may not qualify if:

  • psychotic symptoms
  • bipolar symptoms
  • drug or alcohol dependency
  • dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • S Weidt, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 18, 2016

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 2, 2017

Record last verified: 2017-05