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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stroke; Stress; Anxiety
• Intervention / Treatment: Behavioral: Mindfulness Based Intervention; Other: Health Education Program

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Based Intervention; 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.	Behavioral: Mindfulness Based Intervention; 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.
Active Comparator: Health Education Program; 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.	Other: Health Education Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohen Perceived Stress Scale, PSS	A 10-item measure evaluating the perception of stress.	An average of 1 Month
Centre for Epidemiologic Studies Depression Scale (CES-D)	A 20-item measure for epidemiological research on depression.	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.	An average of 1 month
Stroke Impact Scale (SIS)	A 64-item questionnaire that assesses across 8 domains	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.	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.	State: Current state, Trait: An average of 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zarit Burden Inventory (ZBI)	A 22-item self-report questionnaire to measure for level of caregiver burden or stress.	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.	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.	An average of 1 month

Collaborators and Investigators

• Sponsor: Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): April 15, 2020
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): June 15, 2021
• Last Update Submitted That Met QC Criteria: June 13, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Mindfulness; Caregivers; Stroke Survivors
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 201711-00071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Preliminary data to inform design of future studies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No