RADAR-MDD is a clinical study aiming to assess the utility of multiparametric RMT in clinical populations with MDD. Specifically, the aims of this study are to: 1) Determine the usability, feasibility and acceptability of, and adherence to, RMT to…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoint the presence of a new or continuing major depressive episode
(IDS-SR & CIDI-SF).
Secondary outcome
self-esteem (RSES), anxiety (GAD7) , quality of life (WSAS), and illness
perception (BIPQ), MDD remission (IDS-SR & CIDI-SF).
Background summary
The last decade has seen an explosion in the capability of monitoring
individuals via sensors in smartphones or wearable devices. The development of
remote measurement technologies (RMT) is an innovation which could, in the
foreseeable future, be used to predict and avert negative clinical outcomes, as
well as providing predictive information indicative of future deterioration.
RMT has been hailed as a paradigm shift in the way in which clinical services
can be delivered, but will require healthcare adaptation for its delivery. The
aim of RADAR-MDD is to evaluate the utillity of remote technologies (smartphone
apps and Fitbit) to assist in the early identification of relapse or
deterioration.
Study objective
RADAR-MDD is a clinical study aiming to assess the utility of multiparametric
RMT in clinical populations with MDD.
Specifically, the aims of this study are to: 1) Determine the usability,
feasibility and acceptability of, and adherence to, RMT to provide real-time
objective multidimensional indications of clinical state in individuals with
MDD. 2) Improve and refine clinical outcome measurement using RMT as a means of
identification of current clinical state. 3) Determine whether multi-parametric
RMT collected in populations with recurrent MDD can provide information
predictive of depressive relapse and other critical outcomes.
Study design
observational non-randomised, non-interventional study in which data is
collected through a smartphone app and fitness tracker and where participants
fill out questionnaires.
Study burden and risks
Risks in this study are minimal as measurements are not invasive. There is a
risk that the used study technologies are hacked, but this risk is no greater
than with any smartphone or fitness tracker. The encryption and data
de-identification processes used will minimize any risk in the unlikely event
of hacking. There are no immediate benefits for the participants. As this is an
observational study, the burden is limited to time needed to fill out
questionnaires and online tests.
De Crespigny Park 16
London SE5 8AF
GB
De Crespigny Park 16
London SE5 8AF
GB
Listed location countries
Age
Inclusion criteria
* Aged 18 or over
* Meet DSM-5 diagnostic criteria for diagnosis of non-psychotic MDD within the past 2 years
* Recurrent MDD (a lifetime history of at least 2 episodes of depression
* Willing and able to complete self-reported assessments via smartphone.
* Able to give informed consent for participation.
* Fluent in English, Spanish, Catalan or Dutch language
* Existing ownership of Android smartphone or willingness to use an Android smartphone as their only smartphone.
Exclusion criteria
* Lifetime history of bipolar disorder, schizophrenia, MDD with psychotic features, schizoaffective disorders.
* Dementia
* History of moderate to severe drug or alcohol abuse within 6 months
* History of major medical disease which might impact upon the patient*s ability to participate in normal daily activities for more than 2 weeks (e.g. due to likely hospitalisations or other periods of indisposition).
* Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63557.029.17 |