Stroke Of Mindfulness: Investigating Physiological and Psychological Well-being
Condition: Stroke; Stress; Anxiety; Depression
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study evaluates the impact of mindfulness-based interventions on psycho-social and
      physiological well-being among stroke survivors and their family caregivers. This study will
      employ a treatment wait-list cross-over design, with half the participants randomized to
      receive the intervention first (treatment group), while the other half receives the
      interventions 2 months following the end of the treatment phase (wait-list group).
    

Detailed description: 
      Stroke survivors face many concerns, including the physical, psychological, cognitive and
      psychosocial consequences of stroke, as well as impaired function and quality of life. Also
      important for stroke survivors is the possibility of recurrence that may result in death and
      further disability. Survivors depend on their caregivers to provide assistance for daily
      living tasks, emotional support and taking on new roles and responsibilities with changing
      social dynamics, often causing long-term strain.

      Mindfulness-based interventions (MBIs) are psychotherapeutic interventions which have been
      shown to improve psychological, physiological and psychosocial outcomes such as anxiety,
      depression, mental fatigue, blood pressure and overall quality of life. However, data is
      limited for stroke survivors and their caregivers, especially in Asians. This study will
      evaluate the impact of MBIs on the psychological well-being and perceived quality of life
      among stroke survivors and their family caregivers in Singapore.

      This study employs a randomized treatment-waitlist crossover design with outcome measures
      administered before and after the intervention as well as at 3 months follow-up for the
      treatment group.

      The intervention consists of 4 weekly 2-hour mindfulness sessions. Participants will be
      introduced, taught and guided in practice of mindfulness-based interventions that are focused
      on their (1) breath, (2) senses, (3) body and bodily movement, (4) feelings of empathy and
      compassion. Pre- and post-intervention questionnaires will be conducted to assess symptoms
      associated with depression, anxiety, stress and perceived quality of life. Blood pressure and
      heart rate variability recordings before and after intervention will also be noted.
    

Intervention name(s): Mindfulness-Based Intervention; Waitlist - Mindfulness-Based Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 4 weekly 2-hour sessions. Participants will be introduced, taught and guided in practice of mindfulness-based interventions that are focused on their (1) breath, (2) senses, (3) body and bodily movements, (4) feelings of empathy and compassion.; Participants in this group will only receive the Mindfulness-Based Intervention 3-months after they have started the study and baseline measurements. While participants in the Intervention Arm are receiving the treatment, this group will receive No intervention for the first four weeks and will continue as treatment as usual until it is their turn to receive the Intervention.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants are randomized to receive either the intervention or treatment as usual. The intervention is for 4 weeks, and 3 months from the start of the intervention, participants who were assigned to the treatment as usual group will receive the same intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness; Stroke Survivors; Caregivers