search
Back to results

Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers (SOMII)

Primary Purpose

Stroke, Stress, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Mindfulness Based Intervention
Health Education Program
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Mindfulness, Stroke Survivors, Caregivers

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Stroke survivors and/ or their
  • Family Caregivers
  • Comprehends and provides consent independently

Exclusion Criteria:

-Cognitively impaired individuals with a MMSE score of less than 20, and a MoCA score of less than 23.

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Based Intervention

Health Education Program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cohen Perceived Stress Scale, PSS
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.
The State-Trait Anxiety Inventory, STAI
The STAI is a commonly used measure of trait and state anxiety.

Secondary Outcome Measures

Zarit Burden Inventory (ZBI)
A 22-item self-report questionnaire to measure for level of caregiver burden or stress.
The Big Five Personality Inventory, BFI
44-item inventory that measures an individual on the Big Five Factors (dimensions) of personality.
Five Facet Mindfulness Questionnaire, FFMQ
This 39-item instrument is based on a factor analytic study of five independently developed mindfulness questionnaires.

Full Information

First Posted
February 12, 2019
Last Updated
June 13, 2021
Sponsor
Singapore General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03910855
Brief Title
Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers
Acronym
SOMII
Official Title
Investigating the Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
April 15, 2020 (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 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.

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
Parallel Assignment
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)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education Program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Health Education Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cohen Perceived Stress Scale, PSS
Description
A 10-item measure evaluating the perception of stress.
Time Frame
An average of 1 Month
Title
Centre for Epidemiologic Studies Depression Scale (CES-D)
Description
A 20-item measure for epidemiological research on depression.
Time Frame
An average of 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
An average of 1 month
Title
Stroke Impact Scale (SIS)
Description
A 64-item questionnaire that assesses across 8 domains
Time Frame
An average of 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 4 to 52 weeks
Title
The State-Trait Anxiety Inventory, STAI
Description
The STAI is a commonly used measure of trait and state anxiety.
Time Frame
State: Current state, Trait: An average of 1 month
Secondary Outcome Measure Information:
Title
Zarit Burden Inventory (ZBI)
Description
A 22-item self-report questionnaire to measure for level of caregiver burden or stress.
Time Frame
An average of 1 month
Title
The Big Five Personality Inventory, BFI
Description
44-item inventory that measures an individual on the Big Five Factors (dimensions) of personality.
Time Frame
An average of 1 month
Title
Five Facet Mindfulness Questionnaire, FFMQ
Description
This 39-item instrument is based on a factor analytic study of five independently developed mindfulness questionnaires.
Time Frame
An average of 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 and/ or their Family Caregivers Comprehends and provides consent independently Exclusion Criteria: -Cognitively impaired individuals with a MMSE score of less than 20, and a MoCA score of less than 23.
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

Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers

We'll reach out to this number within 24 hrs