The present study will evaluate potential etiological models for sleep disturbances, depressive symptoms and cognitive impairment using an innovative idiographic design using time-series analysis that accounts for both intra-individual variability (…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
Dementie en amnestische stoornissen (onder psychische stoornissen)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Temporal patterns of depressive symptoms, cognitive function and sleep
disturbances. Unique to time-series analyses all three variables can be both
determinant and outcome (which may differ between patients, see analyses).
Secondary outcome
See also the document: "overzicht metingen".
Inclusion interview:
- Presence of DSM-IV diagnosis of depression (MINI)
- Severity of depressive symptoms (GDS-15)
- Cognitive screen: MOCA
Patient characteristics at baseline, from baseline questionaire:
- Demographic variables (age, sex, living situation, marital status, education
level, work)
- Smoking
- Somatic diseases
- Treatments for depression and/or sleep disturbances
- Presence and severity of sleep disturbances (PSQI)
- Chronotype (MCTQ)
- Restless legs syndrome
- Sleep apnea
- Medication use (assessed by researcher during baseline assessment)
Patient characteristics from medical files:
- Results of diagnostic tests to evaluate the likelihood of Alzheimer's disease
(among which, MRI, PET, lumbar punction)
- Results of neuropsychological examination to evaluate the degree of cognitive
impairments
Daily measured variables used in time-series analyses to evaluate their
influence on the temporal patterns of depression, sleep disturbances and
cognitive functioning:
- Parameters of circadian rhythm and objective sleep disturbances assessed with
actiwatch
- Subjective memory impairments, assessed in electronic diary
- Use of sleeping pills, assessed in electronic diary
- Physical activity, assessed in electronic diary
- Daily use of alcohol, cafeine and cigarettes, assessed in electronic diary,
- Pain, assessed in electronic diary
- Important events, assessed in electronic diary
Weekly evaluated by researchter during telephone interview:
- Changes in (any) medications
- Changes in therapies for depression or sleep disturbances
- Important events
End of study period questionnaire:
- Experiences of participant with the study/data collection
Two months after end of study (= 4 months after start of study)
- Insight questionnaire asking patient whether he or she gained more insight
into the causes of his/her depressive complaints and/or sleep problems and/or
cognitive complaints
Three months after end of study period:
- Insight questionnaire asking treating specialsts whether he or she gained
more insight into the causes of depressive complaints, sleep problems, or
cognitive complaints of his/her patient and whether this gave him or her a new
indication for treatment plans.
Background summary
Sleep disturbances and depression are prevalent in older individuals with
cognitive impairments, and the three conditions are strongly interrelated. As
regards the interconnections between these factors and their causal primacy,
however, much remains unclear. Previous studies, including cohort studies and
randomized controlled trials have neglected the existence of two important
features. First, they neglected the existence of individual heterogeneity by
calculating group means. Second, they neglected the existence of temporal
variation within individuals by using only a few measurements over time.
Study objective
The present study will evaluate potential etiological models for sleep
disturbances, depressive symptoms and cognitive impairment using an innovative
idiographic design using time-series analysis that accounts for both
intra-individual variability (temporal fluctuations) and inter-individual
heterogeneity (different etiological models for individuals).
In addition it will be evaluated whether feedback of personal results to
patients and their treating specialists gives them insight into possible
trigger(s) of depressive symptoms, sleep problems or cognitive problems and
whether this gives treating specialists an indication for treatment plans.
Study design
An observational, idiographic (single-subject) study-design with detailed
repeated assessments will be used. Participants will fill out an electronic
diary twice a day for 60 consecutive days to evaluate sleep disturbances,
depression, and cognitive functioning. In addition, participants will wear an
actiwatch to objectively assess sleep disturbances and alterations in the
circadian rhythm. Time-series analysis will be performed at the individual
participant level to evaluate the temporal patterns and associations between
the parameters of interest for each individual participant.
Study burden and risks
There are no risks involved in participating in the study. The burden of
participating in the study consists of: 1) inclusion interview and baseline
assessments, 2) one visit to hospital at baseline, and 3 additional visits
either to hospital or from researcher at home according to preference, 3)
filling out an electronic diary twice a day, wearing the actiwatch
continuously, and weekly contact with researcher during the 3-days practice-
and the 60-days study period, 4) filling out a questionnaire after study-end,
5) filling out a questionnaire 2 months after the 60-days study period.
Benefits for the participants may include an increased insight in the temporal
dynamics of cognitive function, depression, sleep disturbances and some
behavioural and environmental variables. This may even result in more optimal
treatments for some participants.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Age 60 or above
- informed consent given by patient
- cognitive deficits according to memory clinic or MMSE<26 or MOCA<25
- Depressive episode or GDS>3
Exclusion criteria
- severe medical illness known to influence short-term survival;- Moderate and severe dementia (indicated by Clinical Dementia Rating Scale 2 or 3)
- neurological disorders (other than MCI or dementia as defined in the inclusion criteria);- presence of the following mental health disorders in the past 2 years: bipolar disorder,
psychotic disorders, severe substance use disorders;- incapable of participation in study procedures (i.e. non-Dutch language, incapable of
filling in the diaries, no internet connection at home);- mentally incompetent to give consent for study participation according to judgement of treating specialist;- Incapable to participate in study as it shows from the 3-day practice period (for example not being capable of using the ipad, intolerance to actiwatch, forgetting assessments)
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 | NL43301.042.13 |