Clinical trial NCT03659409: Stroke Of Mindfulness: Investigating Physiological and Psychological Well-being
Official title: Investigating the Impact of Mindfulness on the Physiological and Psychological Well-being of Stroke Survivors and Their Caregivers.
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: 2018-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cohen Perceived Stress Scale
timeFrame: Past 1 Month
measure: Centre for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Past 1 Week
measure: Stroke Specific Quality of Life Scale (SS-QOL)
timeFrame: Past 1 Month
measure: Stroke Impact Scale (SIS)
timeFrame: 1 week
measure: Short-Form-36 (SF-36)
timeFrame: A range from the past 4 to 52 weeks
Secondary outcomes:
measure: Zarit Burden Interview
timeFrame: Past 1 Month
measure: Five Facet Mindfulness Questionnaire
timeFrame: Past 1 Month
measure: Big Five Personality Inventory
timeFrame: Past 1 Month
Other outcomes:
measure: Mental Fatigue Scale (MFS)
timeFrame: 1 Month
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Kinjal Doshi, PhD
role: PRINCIPAL_INVESTIGATOR
References: