Stroke Of Mindfulness: Investigating Physiological and Psychological Well-being (SOM)
Primary Purpose
Stroke, Stress, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Mindfulness-Based Intervention
Waitlist - Mindfulness-Based Intervention
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Mindfulness, Stroke Survivors, Caregivers
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
Sites / Locations
- Singapore General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Mindfulness Based Intervention
Treatment Waitlist Group
Arm Description
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 will receive no intervention, except for a baseline follow-up at the start and again at the end of the first phase. 2 months after the end of the first intervention phase, participants in this group will receive the same mindfulness-based intervention for 4 weeks.
Outcomes
Primary Outcome Measures
Cohen Perceived Stress Scale
A 10-item measure evaluating the perception of stress.
Centre for Epidemiologic Studies Depression Scale (CES-D)
A 20-item measure for epidemiological research on depression.
Stroke Specific Quality of Life Scale (SS-QOL)
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)
A 64-item questionnaire that assesses across 8 domains
Short-Form-36 (SF-36)
A 36-item self-report survey of health, including physical and mental health. Higher scaled scores reflect better quality of health.
Secondary Outcome Measures
Zarit Burden Interview
A 22-item self-report questionnaire to measure for level of caregiver burden or stress.
Five Facet Mindfulness Questionnaire
This 39-item instrument is based on a factor analytic study of five independently developed mindfulness questionnaires. The analysis yielded five factors that appear to represent elements of mindfulness as it is currently conceptualized. The five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Big Five Personality Inventory
44-item inventory that measures an individual on the Big Five Factors (dimensions) of personality (Goldberg, 1993). Each of the factors is then further divided into personality facets.
Full Information
NCT ID
NCT03659409
First Posted
May 13, 2018
Last Updated
March 17, 2020
Sponsor
Singapore General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03659409
Brief Title
Stroke Of Mindfulness: Investigating Physiological and Psychological Well-being
Acronym
SOM
Official Title
Investigating the Impact of Mindfulness on the Physiological and Psychological Well-being of Stroke Survivors and Their Caregivers.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 12, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stress, Anxiety, Depression
Keywords
Mindfulness, Stroke Survivors, Caregivers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Based Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Waitlist Group
Arm Type
Other
Arm Description
Participants will receive no intervention, except for a baseline follow-up at the start and again at the end of the first phase. 2 months after the end of the first intervention phase, participants in this group will receive the same mindfulness-based intervention for 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist - Mindfulness-Based Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cohen Perceived Stress Scale
Description
A 10-item measure evaluating the perception of stress.
Time Frame
Past 1 Month
Title
Centre for Epidemiologic Studies Depression Scale (CES-D)
Description
A 20-item measure for epidemiological research on depression.
Time Frame
Past 1 Week
Title
Stroke Specific Quality of Life Scale (SS-QOL)
Description
A 49-item self-report questionnaire designed to measure the heath related quality of life specific to stroke survivors across 12 domains.
Time Frame
Past 1 Month
Title
Stroke Impact Scale (SIS)
Description
A 64-item questionnaire that assesses across 8 domains
Time Frame
1 week
Title
Short-Form-36 (SF-36)
Description
A 36-item self-report survey of health, including physical and mental health. Higher scaled scores reflect better quality of health.
Time Frame
A range from the past 4 to 52 weeks
Secondary Outcome Measure Information:
Title
Zarit Burden Interview
Description
A 22-item self-report questionnaire to measure for level of caregiver burden or stress.
Time Frame
Past 1 Month
Title
Five Facet Mindfulness Questionnaire
Description
This 39-item instrument is based on a factor analytic study of five independently developed mindfulness questionnaires. The analysis yielded five factors that appear to represent elements of mindfulness as it is currently conceptualized. The five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Time Frame
Past 1 Month
Title
Big Five Personality Inventory
Description
44-item inventory that measures an individual on the Big Five Factors (dimensions) of personality (Goldberg, 1993). Each of the factors is then further divided into personality facets.
Time Frame
Past 1 Month
Other Pre-specified Outcome Measures:
Title
Mental Fatigue Scale (MFS)
Description
A 15-item questionnaire that cover the most common symptoms that occur after brain injury such as that sustained after a stroke.
Time Frame
1 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kinjal Doshi, PhD
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Preliminary data to inform design of future studies.
Learn more about this trial
Stroke Of Mindfulness: Investigating Physiological and Psychological Well-being
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