The primary goal of the study is to examine whether fluctuations in cognitive functioning can be measured in daily life. Another goal is to study which factors influence cognitive functioning in daily life. Finally, it will be examined whether…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cognition assessed in daily life
Social cognition assessed in daily life
Negative symptoms assessed in daily life
Positive symptoms assessed in daily life
Fluctuations in both cognition and social cognition in daily life and
the influence of these fluctuations on positive and negative symptoms
Secondary outcome
Saliva samples will be collected for the purpose of molecular genetic studies.
These studies aim at selecting SNPs (parts of the DNA where one nucleotide is
different from one person to another) that contribute to the psychosis
phenotype.
Background summary
Individuals with psychosis often have cognitive complaints, such as
difficulties with concentration or memory complaints. It is known that
cognitive problems are related with the negative symptoms of psychosis like
lack of motivation or anhedonia. Additionally, negative symptoms have a large
influence on quality of life and daily functioning. The current study focuses
on the cognitive problems that individuals with psychosis or a subclinical
psychosis encounter in daily life.
The main goals are to examine fluctuations in cognition (concentration,
attention, planning skills) in daily life, and to examine the diagnostic value
of cognition in daily life for subclinical psychosis. Another aim is to study
the fluctuation of negative and positive symptoms in daily life, and their
association with social and cognitive functioning.
Study objective
The primary goal of the study is to examine whether fluctuations in cognitive
functioning can be measured in daily life. Another goal is to study which
factors influence cognitive functioning in daily life. Finally, it will be
examined whether fluctuations in cognitive functioning are related to specific
psychological complaints.
Study design
This is an observational study which consists of 4 appointments and 6 days of
measuring symptoms in daily life with the aid of an electronic device
(PsyMate). During the first appointment the participant will receive
information about the study, and has the opportunity to ask questions.
During the second appointment the participant signs informed consent, and
during the second and third appointment several questionnaires and neurological
tasks will be done. Additionally, the participant receives information about
the PsyMate. The PsyMate is a small device which the participant will carry for
6 consecutive days. The PsyMate beeps at random moments during the day, after
wich the participant will fill out a short questionnaire and will do a short
(social) cognition task. The PsyMate enables the measurement of cognition and
fluctuation thereof in daily life. During the second meeting the participant
will also be asked to provide a saliva sample for the study of DNA.
During the fourth meeting, the participant is asked about the experiences
during the PsyMate week, and will complete several computertasks that asses
neuropsychological (attention, speed, processing of information, etc.)
functioning.
Study burden and risks
The total time of participation in this study is 6 hours per participant, for
which participants receive a reinbursement which is in proportion with respect
to the invested time (by the participant). Given the fact that none of the
tasks in the study (filling in questionnaires, doing (computerised) tasks,
carrying the PsyMate and providing a saliva sample) has any risk, the
participation is without risk for the participants.
The inclusion of under aged subjects (aged 15 years or older) is based on this
minimal risk, and the fact that subclinical psychosis typically develops during
adolescence, which would lead to non sufficient sample sizes if only adults
were included in this study.
Vijverdalseweg 1
Maastricht 6226 NB
NL
Vijverdalseweg 1
Maastricht 6226 NB
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for the early psychosis group are: (i) the presence of attenuated psychotic symptoms, brief limited intermittent psychotic symptoms, genetic risk or the occurrence of a psychotic episode according to DSM-IV criteria, , (ii) age 15-35 years, (iii) sufficient knowledge of the Dutch language.;Inclusion criteria for the chronic psychosis group are: (i) life time occurrence of a psychotic episode according to DSM-IV criteria, (ii) illness onset > 6 years, (iii) age 25-55 years, (iv) sufficient knowledge of the Dutch language.
Exclusion criteria
Exclusion criteria for the early psychosis group are: (i) onset of symptoms >2 years, (ii) frequent drug use (>2 times a week), (iii) Mental Retardation (IQ score <70), (iiii) psychosis with organic cause. ;Exclusion criteria for the chronic psychosis group are: (i) illness onset <6 years, (ii) frequent drug use (>2 times a week), (iii) Mental Retardation (IQ score <70), (iiii) psychosis with organic cause.
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 | NL35154.068.11 |