Stroke Of Mindfulness: Investigating Physiological and Psychological Well-being (SOM)

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).

Study Overview

• Status: Completed
• Conditions: Depression; Stroke; Stress; Anxiety
• Intervention / Treatment: Behavioral: Mindfulness-Based Intervention; Behavioral: Waitlist - Mindfulness-Based Intervention

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 Type: Interventional
• Enrollment (Actual): 50
• 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: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Based Intervention; 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.	Behavioral: Mindfulness-Based Intervention; 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.
Other: Treatment Waitlist Group; 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.	Behavioral: Waitlist - Mindfulness-Based Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohen Perceived Stress Scale	A 10-item measure evaluating the perception of stress.	Past 1 Month
Centre for Epidemiologic Studies Depression Scale (CES-D)	A 20-item measure for epidemiological research on depression.	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.	Past 1 Month
Stroke Impact Scale (SIS)	A 64-item questionnaire that assesses across 8 domains	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 the past 4 to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zarit Burden Interview	A 22-item self-report questionnaire to measure for level of caregiver burden or stress.	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.	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.	Past 1 Month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Fatigue Scale (MFS)	A 15-item questionnaire that cover the most common symptoms that occur after brain injury such as that sustained after a stroke.	1 Month

Collaborators and Investigators

• Sponsor: Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: May 13, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

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: 2016/2361

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