Investigating the Impact of Mindfulness on the Physiological and Psychological Well-being of Stroke Survivors and Their Caregivers.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Singapore General Hospital
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Cohen Perceived Stress Scale
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Stroke Survivors
- •Family Caregivers
- •Able to speak and understand English Fluently
- •Comprehends and provides consent independently
Exclusion Criteria
- •Cognitively impaired individuals with a MMSE Score of less than 20, MoCA score of less than 23
- •Depression and Anxiety Stress Scale Scores, DASS, Depression >7, Anxiety >8, and Stress >13
Outcomes
Primary Outcomes
Cohen Perceived Stress Scale
Time Frame: Past 1 Month
A 10-item measure evaluating the perception of stress.
Centre for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Past 1 Week
A 20-item measure for epidemiological research on depression.
Stroke Specific Quality of Life Scale (SS-QOL)
Time Frame: Past 1 Month
A 49-item self-report questionnaire designed to measure the heath related quality of life specific to stroke survivors across 12 domains.
Stroke Impact Scale (SIS)
Time Frame: 1 week
A 64-item questionnaire that assesses across 8 domains
Short-Form-36 (SF-36)
Time Frame: A range from the past 4 to 52 weeks
A 36-item self-report survey of health, including physical and mental health. Higher scaled scores reflect better quality of health.
Secondary Outcomes
- Zarit Burden Interview(Past 1 Month)
- Five Facet Mindfulness Questionnaire(Past 1 Month)
- Big Five Personality Inventory(Past 1 Month)