Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers
Condition: Stroke; Stress; Anxiety; Depression
MeSH terms: Stroke
Study type: Interventional

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.
    

Intervention name(s): Mindfulness Based Intervention; Health Education Program
Intervention type(s): Behavioral; Other
Intervention description(s): The mindfulness-based intervention consists of four 2-hour sessions covering various mindfulness techniques (e.g. mindfulness of breath, body and movement, senses and informal practice, and empathy and compassion) that pertain to stroke survivors and their family caregivers. Participants will be provided handouts for the information covered during these talks and discussions.; The health education program consists of four 2-hour sessions covering various health topics (e.g. diet, nutrition and exercise) that pertain to stroke survivors. Participants will be provided handouts for the information covered during these talks and discussions.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness; Stroke Survivors; Caregivers