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NCT Number: NCT03659409

Stroke Of Mindfulness: Investigating Physiological and Psychological Well-being

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).

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Key information

Conditions

Stroke Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Mental Disorders Nervous System Diseases Stress Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore, 169608

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based Intervention

Behavioral

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 Intervention

Behavioral

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.

Primary outcomes

  1. Cohen Perceived Stress Scale

    Time frame: Past 1 Month

    A 10-item measure evaluating the perception of stress.

  2. Centre for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: Past 1 Week

    A 20-item measure for epidemiological research on depression.

  3. 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.

  4. Stroke Impact Scale (SIS)

    Time frame: 1 week

    A 64-item questionnaire that assesses across 8 domains

  5. 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.

Secondary outcomes

  1. Zarit Burden Interview

    Time frame: Past 1 Month

    A 22-item self-report questionnaire to measure for level of caregiver burden or stress.

  2. Five Facet Mindfulness Questionnaire

    Time frame: Past 1 Month

    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.

  3. Big Five Personality Inventory

    Time frame: Past 1 Month

    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.

Other outcomes

  1. Mental Fatigue Scale (MFS)

    Time frame: 1 Month

    A 15-item questionnaire that cover the most common symptoms that occur after brain injury such as that sustained after a stroke.

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study title

Investigating the Impact of Mindfulness on the Physiological and Psychological Well-being of Stroke Survivors and Their Caregivers.

Acronym: SOM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2018
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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