Depression
Conditions
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.
Interventions
DEVICEMobile sensing
Sponsors
Switzerland: ETH
Switzerland: Makora
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire - for depression (PHQ-9) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Client satisfaction with the app is assessed |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire - for depression (PHQ-9) change | 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 |
Outcome results
None listed