Psychological stress experienced by family caregivers of people with dementia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Adult caring relative of a person aged 60 or older with diagnosed dementia who is currently being cared for at home and will continue to be so in the foreseeable future (at least 3 months) (no plans to move to a nursing home). - The care and support must average at least 1.5 hours per day or at least 10 hours per week (including travel time). - Access to a telephone or internet connection. - Significant stress related to caregiving reported during the screening interview (two out of three criteria from a brief screening: caregiving-related physical or mental health problems, loneliness, caregiver burden).
Exclusion criteria
Exclusion criteria: - Acute, severe mental illness or ongoing psychotherapy of the participating caregiver - Participation in another intervention study for domestic caregivers - Insufficient knowledge of German - Hearing or vision problems that would make it difficult to conduct telephone interviews or complete questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the level of depressive symptoms among participating family caregivers. This endpoint is measured using the General Depression Scale (ADS; Hautzinger, Bailer, Hofmeister & Keller, 2012), which family caregivers complete as part of a comprehensive assessment alongside other standardized questionnaires at four relevant time points: before randomization and the start of the intervention (T0), halfway through the intervention period as part of an interim evaluation (TZ), after the intervention (T1, 6 months after T0), and at the 6-month follow-up (T2, 12 months after T0 or 6 months after T1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional standardized questionnaires will assess the following domains at each assessment time point: resource utilization, quality of life, mental and physical health, caregiving burden and caregiving-related thoughts, violence in caregiving, and relationship quality: • Anxiety symptoms: Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A; Herrmann-Lingen et al., 2011) • Mental well-being: Visual Analog Scale “Mood” (VAS Mood) • Physical symptoms: Giessen Symptom Questionnaire (GBB–24; Brähler et al., 2008) • Resource utilization: Psychosocial Resource Utilization Questionnaire (PRUQ; Töpfer & Wilz, 2018; Schulz et al., 2024) • Caregiver burden: Sense of Competence Questionnaire (SCQ; Pendergrass et al., 2015) • Relationship quality: Questionnaire (2 items) • Caregiver-related thoughts: Caregiver Thoughts Scale (CTS; Risch et al., 2022) • Grief: Caregiver Grief Scale (CGS; Meichsner et al., 2016) • Psychological flexibility: Committed Action Questionnaire (CAQ-8; Terhorst et al., 2020) • Quality of life: EQ-HWB-S (Peasgood et al., 2022), EQ-5D-5L (EuroQoL, 1990) Further data will be collected from participants as part of the process evaluation and for the health economic evaluation. | — |
Countries
Germany
Contacts
Friedrich-Schiller-Universität Jena, Institut für Psychologie