The overall aim of the current study is to improve quality of life in patients with cognitive disorders. First, by improving diagnosis of PTSD symptoms in these patients. Second, we will estimate comorbidity rate of PTSD in clinical populations of…
ID
Source
Brief title
Condition
- Other condition
- Dementia and amnestic conditions
Synonym
Health condition
Psychiatric disorders and behavioral problems
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
study A:
PTSS: TRADE-interview.
BPSD:The Neuropsychiatric Inventory (NPI-NH), Cornell Depression Scale(CDSS).
Functioning: frailty (Groningen Frailty Indicator (GFI) and physical: sqeezing
force, walking speed)
Physiological stress measures: bloodpressure, hearth rate (variability),
Electrodermal skin conduction (EDA)(measured with Empatica E4 wristband).
Quality of Life: Utility-Weighted Dementia Quality of Life (DEMQOL-U-PROXY) en
EuroQol 5D (EQ5D).
Disease burden: Ervaren Druk Door Informele Zorg (EDIZ)
study B:
PTSS: TRADE-interview.
BPSD:The Neuropsychiatric Inventory (NPI-NH), Cornell Depression Scale (CDSS).
Functioning: frailty (Groningen Frailty Indicator (GFI) and physical: sqeezing
force, walking speed)
Physiological stress measures: bloodpressure, hearth rate (variability),
Electrodermal skin conduction (EDA)(measured with Empatica E4 wristband).
Quality of Life: Utility-Weighted Dementia Quality of Life (DEMQOL-U-PROXY) en
EuroQol 5D (EQ5D).
Disease burden: Ervaren Druk Door Informele Zorg (EDIZ), Resource Use in
Dementia (RUD), medical care use in financial costs (indications, diagnostics,
consultations, procedures, medication
Demographic variables: ethnicity, age, gender, (neuro)psychiatric history
(including comorbid disorders), somatic disorders, marital status, children,
education and employment history, social network, weight, length, use of
alcohol, smoking.
Secondary outcome
Study A & B:
Cognition:Mini Mental State Examination (MMSE), the Frontal Assessment Battery
(FAB).
Personality: (Gerontological Personality Scale (GPS), Heteroanamnestische
persoonlijkheidsvragenlijst (tegenwoordige tijd (HAP(-t)).
Epigenetics: Methylation of FKBP5, SERT and genome-broad DNA (saliva)
`Study B:
Amendement: Persoonlijkheidsfunctioneren : LPFS-BF 2.0 The Level of Personality
Functioning Scale - Brief Form 2.0 Informant version Dutch, PID5BF+ M The
Personality Inventory for DSM-5 and ICD-11-Brief Form Modified - informant
version
Background summary
Traumatic life events can result in severe psychiatric symptoms of which Post
Traumatic
Stress Disorder (PTSD) is the most prevalent. PTSD is associated with chronic
stress and
cognitive dysfunctions and has been described as an independent risk factor for
cognitive decline and dementia (Qureshi, Kimbrell et al. 2010, Yaffe,
Vittinghoff et al. 2010, Wang, Wei et al. 2016, Flatt, Gilsanz et al. 2018).
In other studies such an association has not been found (Sundstrom, Ronnlund et
al. 2014).Qualitative good studies on PTSD in patients with dementia are
missing due to lack of a valid diagnostic tool for PTSD in this subgroup.
PTSD may be difficult to recognize in patients with dementia due to its
complicated presentation.As anamnesis is often compromised in patients
diagnosing PTSD requires expertise. Despite, there is no golden standard
available for trauma screening and measurements of PTSD symptoms in this
patient group. Concisely, recognition of PTSD in patients with dementia is a
conceded issue.
Neuropsychiatric symptoms, such as sleeping disorders, psychotic symptoms,
apathy and impulsivity are described as behavior problems in dementia (BPSD:
behavioral and Psychological Symptoms of Dementia). There is clinical evidence
that traumatic life events and PTSD are risk factors for BPSD.Recognition of
PTSD in patients with dementia is essential to tailor personalized treatment,
i.e. behavior counseling and psychological treatment.
In this study we develop a standardized method (a semi-structured interview:
TRADE-interview) to screen for PTSD in patients with dementia.
Next we will investigate the effects of trauma focused therapy : EMDR
Study objective
The overall aim of the current study is to improve quality of life in patients
with cognitive disorders. First, by improving diagnosis of PTSD symptoms in
these patients. Second, we will estimate comorbidity rate of PTSD in clinical
populations of patients with dementia. The association with BPSD, autonomic
stress measures, frailty, quality of life and perceived disease burden of
caregivers will be investigated. Thereafter, effects of standard care (EMDR
treatment) will be studied and compared with a wait list control group (WLC).
In this study, we have the following hypotheses:
1) The TRADE-interview is reliable, valid and feasible for PTSD in patients
with dementia.
2) PTSD is associated with increased BPSD and physiologic measures of the
sympathetic autonomic nervous system, alterations in epigenetic profiles,
decreased quality of life and increased frailty in patients, increased
perceived disease burden on caregivers with dementia. Personality and cognition
will be taken as co variables.
3) Eye Movement Desensitisation and Reprocessing (EMDR) treatment of PTSD
results in improvement of PTSD the measures mentioned under 2) and in the
amendement : personality functioning.
Study design
The current study compromises 2 major parts:
The first part (study A) concerns a literature review and a Delphi-design to
develop the TRADE-interview (Nov 2019- July 2020). Second, the feasibility and
interrater reliability will be investigated in an observational study design.
Third, we will investigate criterion validity and correlating factors in an
observational study. Convenience sampling will be used.
The second part (study B) is an observational study according to regular
psychological care. EMDR treatment will be allocated at random and compared
with a WLC control group.
Intervention
THE TRADE interview is a questionnaire which may potentially give psychological
distress
Study burden and risks
Nature of burden of participation for the participants (patients and
caregivers) consists of periodic interviews and questionnaires of PTSD, BPSD,
personality functioning and quality of life. There will be some addition
cognitive tests and some physical measurements. The short interviews and
questionnaires do not pose any burden or risk for the participating subjects.
Talking about traumatic life events may be seen as a burden. Though, not
talking about traumatic life events is a shortcoming in old age care. There
will be a psychologist available to provide professional support if necessary.
In study B, patients receive clinical treatment conform (inter)national
practice guidelines for psychiatric hospitals and nursing homes. As clinical
practise shows benefits from EMDR treatment in this patient group - it is not
expected that the treatment will harm patients. Even staying in the WLC group
will not harm, but will only delay the possible positive effects of treatment
(unfortunately, we suggest that most patients with cognitive disorders do not
receive trauma treatment at all nowadays). Saliva samples will be collected for
epigenetic parameters.
Thus the research concerns some additional non-invasive measurements related to
care as usual (diagnostics and treatment) in patients with dementia and
comorbid PTSD
Amendement: some extra time to fill in the questionnaires 5 minutes
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Study A:
To investigate, feasibility, reliability and validity (sensitivity and
specificity) of the TRADE-interview, we include all patients with dementia
(major neurocognitive disorder according to DSM-5 : Alzheimer*s disease,
vascular dementia, frontotemporal dementia, lewy-body dementia, other specified
dementia) receiving care from Mondriaan or Cicero-zorggroep, Meandergroep
Envida or Sevagram, Zuyderland. Patients and legal representative have to give
informed consent.
Study B:
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
-Clinical diagnoses according to DSM-5 with: major neurocognitive disorder,
dementia (Alzheimer*s disease, vascular dementia, frontotemporal dementia,
lewy-body dementia, other specified dementia).
-Patients with a positive life report of traumatic life events and symptoms of
PTSD and eligible for psychiatric treatment according to routine clinical
standards (according to clinical psychiatric evaluation by a psychiatrist or
psychologist).
-Intention to be treated and participate with treatment (including
legal representative).
-Written informed consent (including legal representative and
informant).
Exclusion criteria
Study A:
- Subjects who do not have a family member or concerned caregiver who can
deliver informant information are excluded from the study.
- Subjects who are severely demented and impaired in their verbal
communication: Based on the model of Verdult & van der Kooij on
experience-based care, subjects in phase 3 and 4 will be excluded (Finnema
2015).
- Subject who are expected to give resistance, based on their daily care
experience.
-Major medical or psychiatric conditions that may interfere with the study
procedures, e.g. deafness, severe psychotic conditions.
-Any other condition which in the opinion of the (co-) investigator might
interfere with the evaluation of the study objectives: unpredictable aggressive
outbursts which may threaten the investigator*s safety, serious physical
condition that makes it estimated that participation will be too burdened.
- Language barrier.
Study B:
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Subjects who do not have a family member or concerned caregiver who can
deliver informant information are excluded from the study.
- Subjects who are severely demented and impaired in their verbal
communication: Based on the model of Verdult & van der Kooij on
experience-based care, subjects in phase 3 and 4 will be excluded (Finnema
2015).
- Subject who are expected to give resistance, based on their daily care
experience.
-Major medical or psychiatric conditions that may interfere with the study
procedures, e.g. deafness, severe psychotic conditions.
-Any other condition which in the opinion of the (co-) investigator might
interfere with the evaluation of the study objectives: unpredictable aggressive
outbursts which may threaten the investigator*s safety, serious physical
condition that makes it estimated that participation will be too burdened.
- Language barrier.
- Active drug abuse.
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 | NL70479.068.20 |