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Completed

NCT Number: NCT02776839

Mobile Sensing and Support for Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Mobile sensing

Device

Other names: Mobile app

Primary outcomes

  1. Patient Health Questionnaire - for depression (PHQ-9)

    Time frame: baseline

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

Secondary outcomes

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

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

    Client satisfaction with the app is assessed

Other outcomes

  1. Patient Health Questionnaire - for depression (PHQ-9) change

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

    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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Switzerland: ETH
  • Switzerland: Makora

Registry information

Official study title

Monocentric Study for Development of a Smartphone Application for Patients With Depressive

Acronym: MOSS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 18, 2016
Registry last updated
Jun 2, 2017

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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