StrokeSOMNCT03659409
Stroke Of Mindfulness: Investigating Physiological and Psychological Well-being
A study testing Mindfulness-Based Intervention and Waitlist - Mindfulness-Based Intervention in people with Stroke and Stress, run by Singapore General Hospital at 1 site in Singapore.
Trial 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)… 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 Waitlist - Mindfulness-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 12 May 2016to 31 Dec 2018
- 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
- Family Caregivers
- Able to speak and understand English Fluently
- Comprehends and provides consent independently
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Impact of Mindfulness on the Physiological and Psychological Well-being of Stroke Survivors and Their Caregivers.
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).
Read the 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.
- Conditions
- Stroke, Stress, Anxiety, Depression
- Being tested
- Mindfulness-Based Intervention, Waitlist - Mindfulness-Based Intervention
- 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
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.
Waitlist - Mindfulness-Based InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Intervention | Experimental | 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. Receives: Behavioral: Mindfulness-Based Intervention |
| Treatment Waitlist Group | Other | 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. Receives: Behavioral: Waitlist - Mindfulness-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen Perceived Stress Scale
A 10-item measure evaluating the perception of stress.
Measured: Past 1 Month
Centre for Epidemiologic Studies Depression Scale (CES-D)
A 20-item measure for epidemiological research on depression.
Measured: Past 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: Past 1 Month
Stroke Impact Scale (SIS)
A 64-item questionnaire that assesses across 8 domains
Measured: 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 the past 4 to 52 weeks
Secondary outcomes (3)
Zarit Burden Interview
A 22-item self-report questionnaire to measure for level of caregiver burden or stress.
Measured: Past 1 Month
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.
Measured: Past 1 Month
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.
Measured: Past 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start12 May 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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
- Crossover
- 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)
- Enrolment
- 50 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
- NCT03659409
- Sponsor's protocol ID
- 2016/2361
- Acronym
- SOM
- Status last verified
- Mar 2020
- First submitted
- 13 May 2018
- Last updated
- 19 Mar 2020
- 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 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Mindfulness on the Physiological and Psychological Well-being of Stroke Survivors and Their Caregivers.
- ClinicalTrials.gov ID
- NCT03659409
- Acronym / sponsor ID
- SOM / 2016/2361
- Conditions
- Stroke, Stress, Anxiety, Depression
- Keywords
- Mindfulness, Stroke Survivors, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 12 May 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 Sep 2018 (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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Intervention | Experimental | Behavioral: Mindfulness-Based Intervention4 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. |
| Treatment Waitlist Group | Other | Behavioral: Waitlist - Mindfulness-Based InterventionParticipants 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stroke Survivors
- Family Caregivers
- Able to speak and understand English Fluently
- Comprehends and provides consent independently
Key exclusion criteria (2 listed)
- 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
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 Intervention4 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. | Behavioural | Mindfulness Based Intervention |
| Waitlist - Mindfulness-Based InterventionParticipants 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. | Behavioural | Treatment Waitlist Group |
Primary outcome
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.
3 secondary outcomes
Zarit Burden Interview
Time frame: Past 1 Month
Five Facet Mindfulness Questionnaire
Time frame: Past 1 Month
Big Five Personality Inventory
Time frame: Past 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 19 Mar 2020.
- 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 Waitlist - Mindfulness-Based Intervention 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 4 inclusion and 2 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 19 Mar 2020. 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 (time frame: Past 1 Month). The study lists 5 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 19 Mar 2020.