The objective of the current study is to investigate the feasibility of a within subject longitudinal design to investigate the relationship between cognition, mood, clinical factors and other psychosocial variables that may be of influence in…
ID
Source
Brief title
Condition
- Manic and bipolar mood disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter is the feasibility of the current ESM protocol for
later application to a larger sample.
Secondary outcome
To explore the current ESM questionnaire and to find preliminary evidence with
regard to within-person factors relevant in relationship to cognitive
performance in daily life.
Background summary
Bipolar disorder has been associated with neurocognitive impairments that occur
throughout all mood states. No studies in daily life on cognitive functioning
have been done in bipolar disorder. Therefore, it is currently unknown whether
cognitive deficits also fluctuate from moment-to-moment and interact with the
contextual features in the flow of daily life. A better understanding of this
variation and its determinants seems of crucial importance for the diagnosis
and treatment of these symptoms. Improving our knowledge on the variability of
mood and cognition and their association in the context of daily life will
accelerate our understanding of psychological and biological mechanisms
underlying bipolar disorder. Moreover, it may improve diagnostic and treatment
capacities and foster studies into new treatments.
Study objective
The objective of the current study is to investigate the feasibility of a
within subject longitudinal design to investigate the relationship between
cognition, mood, clinical factors and other psychosocial variables that may be
of influence in patients with a diagnosis of bipolar disorder.
Study design
A observational pilot study, including 10 participants.
Study burden and risks
There are no health risks associated with participation. The total duration of
the participation is estimated at 5,5 hours, divided over 2 sessions and 1 ESM
week. Participation includes: a screening, briefing and an
interview/questionnaires (approximately 120 minutes), one ESM week (6 days with
10 measurement points of each approximately 3 minutes= 180 minutes), and a
debriefing (30 minutes).
Vijverdalseweg 1 1
Maastricht 6226 NB
NL
Vijverdalseweg 1 1
Maastricht 6226 NB
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria are:
(i) life time presence of diagnosis of bipolar I or bipolar II disorder according to DSM-IV criteria,
(ii) age 18-65 years,
(iii) sufficient knowledge of the Dutch language.
Exclusion criteria
(i) Mentally incompetent to give informed consent
(ii) Current alcohol abuse (< 3 months)
(iii) Frequent drug use (>2 times a week),
(iv) Mental Retardation (IQ score <70),
(v) History of a neurological illness or traumatic brain injury with loss of consciousness,
(vi) ECT treatment in the past year
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 | NL51684.068.15 |