DepressionMOSSNCT02776839
Mobile Sensing and Support for Depression
A study testing Mobile sensing in people with Depression, run by University of Zurich.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Mobile sensing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-declaration of depressive symptoms
- app runs on Android 4.0 and higher
- germen speaking
Who cannot join
- psychotic symptoms
- bipolar symptoms
- drug or alcohol dependency
- dementia
About this study
Official title: Monocentric Study for Development of a Smartphone Application for Patients With Depressive
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Mobile sensing
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile sensingDevice
Also called Mobile app
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Mobile sensing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (1)
Client Satisfaction Questionnaire (ZUF-8)- measures client satisfaction with the app
Client satisfaction with the app is assessed
Measured: at post (at least 6 weeks after baseline) however some participants will use the app longer than 6 weeks, maximum 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Switzerland: ETH, Switzerland: Makora
- Responsible party
- Sponsor
- Investigators
- S Weidt, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776839
- Sponsor's protocol ID
- MOSS
- Acronym
- MOSS
- Status last verified
- May 2017
- First submitted
- 9 May 2016
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Study for Development of a Smartphone Application for Patients With Depressive
- ClinicalTrials.gov ID
- NCT02776839
- Acronym / sponsor ID
- MOSS / MOSS
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Switzerland: ETH, Switzerland: Makora
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Sensing | Other | Device: Mobile sensingThis phase of the study is designed to develop the app. due to algorithms the app should lern to detect depressive symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- self-declaration of depressive symptoms
- app runs on Android 4.0 and higher
- germen speaking
Key exclusion criteria (4 listed)
- psychotic symptoms
- bipolar symptoms
- drug or alcohol dependency
- dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile sensingAlso: Mobile app | Device | Mobile Sensing |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S Weidt, MD principal investigator
University of Zurich
Questions about this trial
What is this clinical trial studying?
A study testing Mobile sensing in people with Depression, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire - for depression (PHQ-9) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.