Ignite Creation Date:
2024-05-06 @ 5:49 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05448261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-07-20
First Post:
2022-07-02
Brief Title:
Emotion-centered Problem-solving Intervention for Family Caregivers of Stroke Survivors SoLVE
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
FoStering psychosOcial weLlbeing of Family Caregivers of Stroke surVivors Using Emotion-centered Problem-solving Approach SoLVE A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-07
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:
SoLVE
Brief Summary:
Stroke is one of the leading causes of disability globally Stroke survivors generally require lifelong support from family caregivers The abrupt onset of stroke and associated physical and cognitive impairments result in a series of complex and demanding interactions between family caregivers and stroke survivors More than 40 of stroke caregivers develop depressive symptoms over time The depression of family caregivers negatively impacts their physical health and caregiving role and directly affects the mental health and recovery of stroke survivors Thus effective strategies for stressful caregiving situations are urgently needed
As postulated in the relationalproblem solving model of stress problem-solving coping is a cognitive behavioral process that can enhance caregivers well-being by changing caregiving situations andor changing their negative emotional stress responses to stressful situations into positive responses In view of the influence of negative emotions on the cognitive process of an individual integrating perspective taking as a cognitive reappraisal strategy into the training of problem-solving coping skills may potentially improve the psychosocial well-being of family caregivers
This mixed method study aims 1 to examine the effects of a emotion-centered problem-solving intervention on the depressive symptoms problem-solving coping emotion regulation caregiving competence and health-related quality of life of stroke caregivers and on the physical functioning of stroke survivors 2 to explore the mediating effect of emotion regulation and problem solving coping on caregivers depressive symptoms caregiving competence and health-related quality of life and on stroke survivors physical functioning and 3 to understand how intervention influences depressive symptoms from a family caregivers perspective A total of 178 family caregivers will be recruited from various non-government organizations and nurse clinics for stroke patients of the Hospital Authority Participants will be randomly allocated to the intervention group IG and control group CG Caregivers in the IG will receive an emotion-centered problem-solving intervention adopting a shared problem shared action plan approach whereas the caregivers in the CG will receive stroke-related education Outcomes will be measured at baseline 12 and 36 weeks after study entry
This study makes the first attempt to develop an emotion-centered problem-solving intervention and examine its effectiveness in the context of stroke caregiving The findings will advance our understanding of emotional regulation and problem-solving coping strategies for reducing the depressive symptoms of stroke caregivers ultimately providing a culturally sensitive medical-social service direction for the delivery of community-based rehabilitation services to stroke families
As postulated in the relationalproblem solving model of stress problem-solving coping is a cognitive behavioral process that can enhance caregivers well-being by changing caregiving situations andor changing their negative emotional stress responses to stressful situations into positive responses In view of the influence of negative emotions on the cognitive process of an individual integrating perspective taking as a cognitive reappraisal strategy into the training of problem-solving coping skills may potentially improve the psychosocial well-being of family caregivers
This mixed method study aims 1 to examine the effects of a emotion-centered problem-solving intervention on the depressive symptoms problem-solving coping emotion regulation caregiving competence and health-related quality of life of stroke caregivers and on the physical functioning of stroke survivors 2 to explore the mediating effect of emotion regulation and problem solving coping on caregivers depressive symptoms caregiving competence and health-related quality of life and on stroke survivors physical functioning and 3 to understand how intervention influences depressive symptoms from a family caregivers perspective A total of 178 family caregivers will be recruited from various non-government organizations and nurse clinics for stroke patients of the Hospital Authority Participants will be randomly allocated to the intervention group IG and control group CG Caregivers in the IG will receive an emotion-centered problem-solving intervention adopting a shared problem shared action plan approach whereas the caregivers in the CG will receive stroke-related education Outcomes will be measured at baseline 12 and 36 weeks after study entry
This study makes the first attempt to develop an emotion-centered problem-solving intervention and examine its effectiveness in the context of stroke caregiving The findings will advance our understanding of emotional regulation and problem-solving coping strategies for reducing the depressive symptoms of stroke caregivers ultimately providing a culturally sensitive medical-social service direction for the delivery of community-based rehabilitation services to stroke families
Detailed Description:
None
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