Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05867706
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-03-09
Brief Title:
Caregiver Stress and Bereavement
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
The Psychobiological Adjustment to Bereavement Among Cancer Caregivers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The death of a spouse is considered one of the most stressful and impactful life events and is associated with increased morbidity and premature mortality Early identification of individuals who are most at risk for poor health outcomes following bereavement is an important aim of precision medicine and disease prevention initiatives A better understanding of caregiver burden and bereavement-related distress and its implication for health is a clinically-relevant step toward the development of treatments that improve health outcomes in bereaved spouses This study aims to map profiles of individual differences in short- and long-term adjustment to loss according to psychological eg depression stress grief severity and biological markers eg inflammation cortisol over time
Detailed Description:
The loss of a spouse is a highly impactful life event that places individuals at risk for mental and physical health problems Particularly in the immediate weeks and months after the loss bereavement is associated with a significantly increased risk of multimorbidity and mortality including elevated inflammation cardiovascular diseases and some cancers Grief is a typical reaction to the loss of a significant person and is characterized by symptoms of intense distress anxiety yearning longing and sadness all of which generally subside over time There is considerable variability in how people respond to bereavement Although the vast majority of bereaved individuals show resilience against loss and adjust adequately without professional psychological support 10 - 20 of bereaved individuals develop intense and prolonged grief reactions
The field of psychoneuroimmunology has contributed considerably to our understanding of the effect of stress on the psyche as well as on the nervous immune and endocrine systems Stressful life events and the negative emotions they provoke can induce low-grade inflammation through several autonomic neuroendocrine and neuroimmune pathways which in turn suppress the effectiveness of the immune system and thereby increase vulnerability to physical and mental health problems across a persons lifespan Bereavement is a highly-stressful event which triggers biological responses via several autonomic endocrine and inflammatory mechanisms Growing evidence suggests that the health consequences of caregiving for terminally-ill patients and bereavement after the loss of a spouse are associated with a wide spectrum of neuroendocrine factors and immunologic and inflammatory markers Low-grade systemic inflammation as reflected by elevated concentrations of cytokines eg C-reactive protein CRP interleukin 6 IL-6 tumor necrosis factor alpha TNF-a is a robust risk factor for the onset of many diseases including major depression cardiovascular disease and stroke
The caregivers burden and needs are often not a hospitals priority and overlooked Yet the health consequences of caring for a terminally-ill spouse as well as the need for follow-up care programs for caregivers of a deceased spouse are not well understood Acknowledging that bereavement-related changes in immune function could account considerably for an increased risk of morbidity and mortality in bereaved individuals the identification of biobehavioral mechanisms that can be modified or targeted early is an important and clinically-relevant step toward the development of treatments that improve health outcomes in bereaved individuals
The proposed study is based on the Social Signal Transduction Theory of Depression Slavich et al which suggests that early life stress exposure can shape an individuals neuro-inflammatory sensitivity to stress to later- occurring threats or acute adverse life events and thereby increase their vulnerability to physical and mental health problems across the lifespan
The studys aims are two-fold 1 to map profiles of individual differences in long-term adjustment to loss according to psychological and biological markers over time and 2 to examine whether cumulative lifetime stress exposure and neuro-inflammatory sensitivity to stress moderate the association between an acute stressful life event ie the loss of a terminally-ill spouse after a long period of intensive caregiving and the spouses health outcomes following bereavement and thereby explain individual differences in resilience
The field of psychoneuroimmunology has contributed considerably to our understanding of the effect of stress on the psyche as well as on the nervous immune and endocrine systems Stressful life events and the negative emotions they provoke can induce low-grade inflammation through several autonomic neuroendocrine and neuroimmune pathways which in turn suppress the effectiveness of the immune system and thereby increase vulnerability to physical and mental health problems across a persons lifespan Bereavement is a highly-stressful event which triggers biological responses via several autonomic endocrine and inflammatory mechanisms Growing evidence suggests that the health consequences of caregiving for terminally-ill patients and bereavement after the loss of a spouse are associated with a wide spectrum of neuroendocrine factors and immunologic and inflammatory markers Low-grade systemic inflammation as reflected by elevated concentrations of cytokines eg C-reactive protein CRP interleukin 6 IL-6 tumor necrosis factor alpha TNF-a is a robust risk factor for the onset of many diseases including major depression cardiovascular disease and stroke
The caregivers burden and needs are often not a hospitals priority and overlooked Yet the health consequences of caring for a terminally-ill spouse as well as the need for follow-up care programs for caregivers of a deceased spouse are not well understood Acknowledging that bereavement-related changes in immune function could account considerably for an increased risk of morbidity and mortality in bereaved individuals the identification of biobehavioral mechanisms that can be modified or targeted early is an important and clinically-relevant step toward the development of treatments that improve health outcomes in bereaved individuals
The proposed study is based on the Social Signal Transduction Theory of Depression Slavich et al which suggests that early life stress exposure can shape an individuals neuro-inflammatory sensitivity to stress to later- occurring threats or acute adverse life events and thereby increase their vulnerability to physical and mental health problems across the lifespan
The studys aims are two-fold 1 to map profiles of individual differences in long-term adjustment to loss according to psychological and biological markers over time and 2 to examine whether cumulative lifetime stress exposure and neuro-inflammatory sensitivity to stress moderate the association between an acute stressful life event ie the loss of a terminally-ill spouse after a long period of intensive caregiving and the spouses health outcomes following bereavement and thereby explain individual differences in resilience
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None