Clinical trial NCT03910855: Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers
Official title: Investigating the Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stress
Anxiety
Depression
Keywords: Mindfulness
Stroke Survivors
Caregivers
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive either a Mindfulness-based Intervention (MBI) or a Health Education Program (HEP). The intervention is for 4 weeks. Measures will be administered prior to and on completion of the intervention, and at 3-month follow-up.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Stroke survivors and/ or their
* Family Caregivers
* Comprehends and provides consent independently

Exclusion Criteria:

-Cognitively impaired individuals with a MMSE score of less than 20, and a MoCA score of less than 23.

Primary outcomes:
measure: Cohen Perceived Stress Scale, PSS
timeFrame: An average of 1 Month
measure: Centre for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: An average of 1 Week
measure: Stroke Specific Quality of Life Scale (SS-QOL)
timeFrame: An average of 1 month
measure: Stroke Impact Scale (SIS)
timeFrame: An average of 1 week
measure: Short-Form-36 (SF-36)
timeFrame: A range from 4 to 52 weeks
measure: The State-Trait Anxiety Inventory, STAI
timeFrame: State: Current state, Trait: An average of 1 month
Secondary outcomes:
measure: Zarit Burden Inventory (ZBI)
timeFrame: An average of 1 month
measure: The Big Five Personality Inventory, BFI
timeFrame: An average of 1 month
measure: Five Facet Mindfulness Questionnaire, FFMQ
timeFrame: An average of 1 month
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Kinjal Doshi, PhD
role: PRINCIPAL_INVESTIGATOR
References: