StrokeSOMIINCT03910855
Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers
A study testing Mindfulness Based Intervention and Health Education Program in people with Stroke and Stress, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Mindfulness Based Intervention and Health Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Sep 2018to 15 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke survivors and/ or their
- Family Caregivers
- Comprehends and provides consent independently
Who cannot join
- -Cognitively impaired individuals with a MMSE score of less than 20, and a MoCA score of less than 23.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers: A Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Stroke, Stress, Anxiety, Depression
- Being tested
- Mindfulness Based Intervention, Health Education Program
- Keywords
- Mindfulness, Stroke Survivors, Caregivers
- Medical subject headings
- Stroke, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based InterventionBehavioural
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.
Health Education ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Intervention | Experimental | 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. Receives: Behavioral: Mindfulness Based Intervention |
| Health Education Program | Active comparator | 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. Receives: Other: Health Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen Perceived Stress Scale, PSS
A 10-item measure evaluating the perception of stress.
Measured: An average of 1 Month
Centre for Epidemiologic Studies Depression Scale (CES-D)
A 20-item measure for epidemiological research on depression.
Measured: An average of 1 Week
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.
Measured: An average of 1 month
Stroke Impact Scale (SIS)
A 64-item questionnaire that assesses across 8 domains
Measured: An average of 1 week
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.
Measured: A range from 4 to 52 weeks
The State-Trait Anxiety Inventory, STAI
The STAI is a commonly used measure of trait and state anxiety.
Measured: State: Current state, Trait: An average of 1 month
Secondary outcomes (3)
Zarit Burden Inventory (ZBI)
A 22-item self-report questionnaire to measure for level of caregiver burden or stress.
Measured: An average of 1 month
The Big Five Personality Inventory, BFI
44-item inventory that measures an individual on the Big Five Factors (dimensions) of personality.
Measured: An average of 1 month
Five Facet Mindfulness Questionnaire, FFMQ
This 39-item instrument is based on a factor analytic study of five independently developed mindfulness questionnaires.
Measured: An average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Sep 2018
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kinjal Doshi, PhD, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910855
- Sponsor's protocol ID
- 201711-00071
- Acronym
- SOMII
- Status last verified
- Jun 2021
- First submitted
- 12 Feb 2019
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Preliminary data to inform design of future studies.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03910855
- Acronym / sponsor ID
- SOMII / 201711-00071
- Conditions
- Stroke, Stress, Anxiety, Depression
- Keywords
- Mindfulness, Stroke Survivors, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Intervention | Experimental | Behavioral: Mindfulness Based InterventionThe 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. |
| Health Education Program | Active comparator | Other: Health Education ProgramThe 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke survivors and/ or their
- Family Caregivers
- Comprehends and provides consent independently
Key exclusion criteria (1 listed)
- -Cognitively impaired individuals with a MMSE score of less than 20, and a MoCA score of less than 23.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based InterventionThe 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. | Behavioural | Mindfulness Based Intervention |
| Health Education ProgramThe 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. | Other | Health Education Program |
Primary outcome
Cohen Perceived Stress Scale, PSS
Time frame: An average of 1 Month
A 10-item measure evaluating the perception of stress.
Centre for Epidemiologic Studies Depression Scale (CES-D)
Time frame: An average of 1 Week
A 20-item measure for epidemiological research on depression.
Stroke Specific Quality of Life Scale (SS-QOL)
Time frame: An average of 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: An average of 1 week
A 64-item questionnaire that assesses across 8 domains
Short-Form-36 (SF-36)
Time frame: A range from 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.
The State-Trait Anxiety Inventory, STAI
Time frame: State: Current state, Trait: An average of 1 month
The STAI is a commonly used measure of trait and state anxiety.
3 secondary outcomes
Zarit Burden Inventory (ZBI)
Time frame: An average of 1 month
The Big Five Personality Inventory, BFI
Time frame: An average of 1 month
Five Facet Mindfulness Questionnaire, FFMQ
Time frame: An average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Individual participant dataSharing planned: Undecided. Preliminary data to inform design of future studies.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kinjal Doshi, PhD principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Intervention and Health Education Program in people with Stroke and Stress, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohen Perceived Stress Scale, PSS (time frame: An average of 1 Month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.