Mobile Sensing and Support for Depression

Depression Clinical Trial

— MOSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776839
• Other study ID #: MOSS
• Status: Completed
• Phase: N/A
• First received: May 9, 2016
• Last updated: June 1, 2017
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Mobile sensing

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Switzerland: ETH, Switzerland: Makora

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Health Questionnaire - for depression (PHQ-9) change	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	baseline and every other week for at least 6 weeks up to 6 months
Primary	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	Client Satisfaction Questionnaire (ZUF-8)- measures client satisfaction with the app	Client satisfaction with the app is assessed	at post (at least 6 weeks after baseline) however some participants will use the app longer than 6 weeks, maximum 6 months