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Trauma and Dementia

Trauma and Dementia - TRADE-study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52695
Enrollment
116
Registered
2020-04-07
Start date
2022-05-07
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

Interventions

THE TRADE interview is a questionnaire which may potentially give psychological distress

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
65 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Contacts

Public ContactS. Sobczak

Universiteit Maastricht

sjacko.sobczak@maastrichtuniversity.nl0885066363

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 23, 2026