Ignite Creation Date:
2024-05-06 @ 1:03 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03910855
Status:
COMPLETED
Last Update Posted:
2021-06-15
First Post:
2019-02-12
Brief Title:
Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers
Sponsor:
Singapore General Hospital
Organization:
Singapore General Hospital
Study Overview
Official Title:
Investigating the Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-06
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:
SOMII
Brief Summary:
This study will employ a randomized control design Stroke survivors and family caregivers will be recruited for the study and randomized either to receive mindfulness-based intervention or health education Both programs consist of 4 2-hour sessions Participants of the mindfulness-based intervention MBI will be taught and guided in practice of psychosocial interventions that are focused on 1 stress management and coping skills 2 body awareness and movement 3 feelings of empathy and compassion and 4 motivation for rehabilitation Participants of the health education program HEP will learn and discuss topics related to self-care and post-stroke management Measures will be administered prior to and on completion of the intervention and at 3-month follow-up They will be used to assess symptoms associated with depression anxiety stress perceived quality of life and participant characteristics such as personality variables
Detailed Description:
Stroke prevalence is 3-4 among Singaporeans above the age of 50 and will rise with our aging population Stroke survivors face many concerns including physical psychological cognitive and psychosocial consequences of stroke as well as impaired functioning and quality of life They often rely on their family for physical cognitive and emotional support in order to perform daily functional activities Dependence on family members has been shown to affect the physical mental and emotional well-being of caregivers of stroke survivors Research indicates that the long-term demands of caring for a stroke survivor puts a strain on caregivers who may not be able to provide the appropriate amount of care required to manage the needs of stroke survivors over time
Mindfulness-based interventions MBIs are increasingly being offered as psychotherapeutic interventions for individuals who suffer from medical conditions such as stroke and for their long-term family caregivers Several review studies have shown that MBIs specifically for long-term conditions enhanced the ability to cope with physical difficulties improved mental and emotional well-being as well as overall quality of life promoting better health outcomes A systematic review investigating the use of MBIs with stroke survivors found that psychological physiological and psychosocial outcomes were improved such as anxiety depression mental fatigue and overall quality of life Lawrence et al 2013
However there are limited data for stroke survivors and their caregivers especially among Asians Furthermore there is little attention to study the interaction between participants characteristics and MBIs to determine whether there are any specific moderators that help to maximize the therapeutic outcomes of MBIs Shaprio et al 2011 Although there are growing number of studies correlating personality traits and dispositional mindfulness Hanley 2016 Giluk 2009 little research has been done to examine personality traits as moderators to treatment outcome Research focusing the the five-factor model of personality has demonstrated that the five personality traits have different strengths of correlation with the dispositional mindfulness Among the traits neuroticism displayed the strongest negative correlation with depositional mindfulness while conscientiousness displayed the strongest positive correlation with depositional mindfulness
This study will be the first to examine the moderating effects of personality traits on the impact of mindfulness-based intervention in terms of depression anxiety stress and perceived quality of life of stroke survivors and their family caregivers Furthermore this study will evaluate and compare the impacts of mindfulness-based intervention and health education on the psychological well-being of both the participants Findings will encourage the development of future strategies to understand the variability in treatment response and prognosis as well as to address individual differences with relevant psychotherapy skills
Mindfulness-based interventions MBIs are increasingly being offered as psychotherapeutic interventions for individuals who suffer from medical conditions such as stroke and for their long-term family caregivers Several review studies have shown that MBIs specifically for long-term conditions enhanced the ability to cope with physical difficulties improved mental and emotional well-being as well as overall quality of life promoting better health outcomes A systematic review investigating the use of MBIs with stroke survivors found that psychological physiological and psychosocial outcomes were improved such as anxiety depression mental fatigue and overall quality of life Lawrence et al 2013
However there are limited data for stroke survivors and their caregivers especially among Asians Furthermore there is little attention to study the interaction between participants characteristics and MBIs to determine whether there are any specific moderators that help to maximize the therapeutic outcomes of MBIs Shaprio et al 2011 Although there are growing number of studies correlating personality traits and dispositional mindfulness Hanley 2016 Giluk 2009 little research has been done to examine personality traits as moderators to treatment outcome Research focusing the the five-factor model of personality has demonstrated that the five personality traits have different strengths of correlation with the dispositional mindfulness Among the traits neuroticism displayed the strongest negative correlation with depositional mindfulness while conscientiousness displayed the strongest positive correlation with depositional mindfulness
This study will be the first to examine the moderating effects of personality traits on the impact of mindfulness-based intervention in terms of depression anxiety stress and perceived quality of life of stroke survivors and their family caregivers Furthermore this study will evaluate and compare the impacts of mindfulness-based intervention and health education on the psychological well-being of both the participants Findings will encourage the development of future strategies to understand the variability in treatment response and prognosis as well as to address individual differences with relevant psychotherapy skills
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