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Mobile Sensing and Support for Depression (MOSS)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile sensing
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Mobile Sensing

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 9, 2016
    Last Updated
    June 1, 2017
    Sponsor
    University of Zurich
    Collaborators
    Switzerland: ETH, Switzerland: Makora
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02776839
    Brief Title
    Mobile Sensing and Support for Depression
    Acronym
    MOSS
    Official Title
    Monocentric Study for Development of a Smartphone Application for Patients With Depressive
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Zurich
    Collaborators
    Switzerland: ETH, Switzerland: Makora

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    To conduct a very first pilot trial, a monocentric, single-arm clinical study is conducted. The study is approved by the local ethics committee of the Canton of Zurich in Switzerland and the Swiss Agency for Therapeutic Products. It is conducted in full accordance with the Declaration of Helsinki, with all subjects providing their electronic informed consent prior to participation. As the main interest lies in a proof of concept of the proposed MOSS app, emphasis is put on real life conditions. A range of different recruitment channels is used to attract subjects from the general public; they include physical flyers, online posts on relevant online bulletin boards and the Google Play Store.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    126 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mobile Sensing
    Arm Type
    Other
    Arm Description
    This phase of the study is designed to develop the app. due to algorithms the app should lern to detect depressive symptoms
    Intervention Type
    Device
    Intervention Name(s)
    Mobile sensing
    Other Intervention Name(s)
    Mobile app
    Primary Outcome Measure Information:
    Title
    Patient Health Questionnaire - for depression (PHQ-9)
    Description
    subjective depressive symptoms to compare the detected symptoms measured by the app This outcome is needed for the sensing part of the study
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Client Satisfaction Questionnaire (ZUF-8)- measures client satisfaction with the app
    Description
    Client satisfaction with the app is assessed
    Time Frame
    at post (at least 6 weeks after baseline) however some participants will use the app longer than 6 weeks, maximum 6 months
    Other Pre-specified Outcome Measures:
    Title
    Patient Health Questionnaire - for depression (PHQ-9) change
    Description
    Change of symptoms due to the Support app. As the study is two-fold and also includes a supporting part, this measure is needed for the supporting part of the study
    Time Frame
    baseline and every other week for at least 6 weeks up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: self-declaration of depressive symptoms app runs on Android 4.0 and higher germen speaking Exclusion Criteria: psychotic symptoms bipolar symptoms drug or alcohol dependency dementia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    S Weidt, MD
    Organizational Affiliation
    University of Zurich
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Mobile Sensing and Support for Depression

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