Page 9 research protocol:Objective:The aim of this project is to apply motor-cognitive-mental functions together in psychiatric diagnosis for a better treatment, and prognosis (feasible and practicable and personalized). We will examine and quantify…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Page 9 research protocol:
Main study parameters/endpoints:
The study endpoints are a significant change of affect, aberrant salience,
stress, emotional instability, and/or cognitive function * during the study *
in association with patients* (a) treatment needs, and (b) 6-months treatment
response.
Secondary outcome
na
Background summary
Page 8 of research protocol:
Rationale:
The main function of diagnosis in medicine is to provide accurate information
to predict treatment needs (management) and treatment response (prognosis).
However, in psychiatry the predictive value of (DSM/ICD) *mental* signs and
symptoms is limited. Interestingly, alterations in motor and cognitive function
represent more accurate predictors, likely because they are indicators of
neurodevelopmental liability, and may dramatically enhance diagnostic
usefulness. The critical question is: is it feasible and practicable to add
areas of motor and cognitive function to standard diagnostic function in mental
health care?
Keywords: motor, cognition, mental, treatment, personalised
Study objective
Page 9 research protocol:
Objective:
The aim of this project is to apply motor-cognitive-mental functions together
in psychiatric diagnosis for a better treatment, and prognosis (feasible and
practicable and personalized).
We will examine and quantify the diagnostic value of motor-cognitive-mental
functions in predicting (a) treatment needs, and (b) 6-months treatment
response. It is hypothesized that the diagnostic value of
motor-cognitive-mental functions will yield early predictive parameters of
treatment needs and treatment response, complementing the standardised criteria
in DSM/ICD.
Study design
Page 9 research protocol:
Study design:
Novel ambulatory assessment methodology, i.e. in the flow of daily life, will
be used to collect intensive time-sampling data of mutually impacting motor and
cognitive in addition to mental alterations. I will use novel Motor Sensor
Devices (MSD) in combination with Experience Sampling Methodology (ESM)
(together: MSD-ESM). MSD-ESM makes it possible to collect synchronised
momentary measures of motor, cognitive, and mental alterations. Patients will
collect their own data in the flow of daily life over 3 periods of 2 days: at
baseline, and at 3 and 6 months post-baseline.
Study burden and risks
Page 9 research protocol:
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
The risk associated with the study is minimal. Subjects will be asked to invest
a total of 9 days, divided over three 3-days periods. The risks of using the
device for 2 days are low, while the results vastly improve psychiatric
diagnosis by making it more personalized and by making both diagnosis and
treatment more representative of patients needs. A possible risk is that
patients will pay more attention to negative parameters, like negative affect
and stress. A possible benefit for patients is that they may become aware of
factors which are related to successful treatment response. While some patients
may find the repetitive tests tiresome, in general, patients experience their
collaboration in their own diagnosis as a positive endeavour. This figure will
be the same for all subjects as the study consists of a single group.
Utrechtseweg 266
Amersfoort 3818 EW
NL
Utrechtseweg 266
Amersfoort 3818 EW
NL
Listed location countries
Age
Inclusion criteria
Page 15 of research protocol:
* Minimum age of 18 years, recent-onset affective/psychotic psychopathology, and sufficient command of the Dutch language.
* Is mentally competent (wilsbekwaam) according the algorithm from the Royal Dutch Medical Association (KNMG) , i.e. the patient is able to make choices, understands medical information, can apply this to his/her own situation, and whether he/she is able to logically consider the choice. (Mental incompetence is a legally defined status * there is no straightforward relation between mental incompetence and the underlying diagnosis).
Exclusion criteria
Page 16 of research protocol:
* A history of neurological disorder impacting motor/cognitive/mental function
* GAF-score below 45
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 | NL53733.068.15 |