The aim of this study is to evaluate the effectiveness of a 16 week mindfulness-based coaching program compared to a cardiovascular risk reduction education program. Both groups will undergo 24-hour ambulatory blood pressure monitoring, along with assessments of psychological measures (see bellow) at study baseline, midpoint (8 weeks), and conclusion (16 weeks). In addition, both groups will also undergo 24-hour Holter monitoring assessments at study beginning and conclusion to assess possible episodes of atrial tachyarrhythmia during the assessed interval.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.
Regular in-person meetings, phone calls, or email from study coordinator instructing them on how to integrate exercise and dietary changes in their lifestyle to reduce their risk of future cardiovascular events.
Southlake Regional Health Centre
Newmarket, Ontario, Canada
RECRUITINGNight time (Sleep) Systolic Blood Pressure
The primary outcome of this study will be change in ANBP from baseline when compared to subsequent follow-up study time points.
Time frame: 16 weeks
Daytime time (Awake) Systolic Blood Pressure
The primary outcome of this study will be change in daytime ABP from baseline when compared to subsequent follow-up study time points.
Time frame: 16 Weeks
Nocturnal Dipping
ANBP will be calculated as the percentage of nocturnal drop in systolic blood pressure in relation to its daytime values
Time frame: 16 Weeks
Atrial Tachyarrhythmia Episodes
24-hour Holter monitoring assessments using the MARS® ambulatory ECG system at baseline and 4 months to assess atrial tachyarrhythmia episodes lasting 30 seconds or more
Time frame: 16 Weeks
Hospital Anxiety and Depression Scale (HADS)
14 item self-report questionnaire evaluating anxiety and depression symptoms in medical populations
Time frame: 16 Weeks
Profile of Mood States (POMS-SF)
65 item self-report questionnaire examining mood and changes in mood over a period, POMS, in both original and shorter 37 item format, has been extensively used in clinical settings
Time frame: 16 Weeks
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
24 item the magnitude and changes over time in mindfulness levels, including its five - observing, describing experience, acting with awareness, non-judging of inner experience, and nonreactivity to inner experience facets.
Time frame: 16 Weeks
SF-12 v2 Health Survey
assesses self reported physical and mental health, providing separate scores for 8 sub-domains of physical and mental health (e.g. physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health).
Time frame: 16 Weeks
Pittsburgh Sleep Quality Index (PSQI)
The instrument, widely used in epidemiological or clinical contexts, is comprised of seven sub-components (i.e. sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, medication use, and daytime dysfunction) leading to a global sleep quality score.
Time frame: 16 Weeks
Cardiac Anxiety Questionnaire (CAQ)
18 item index of HFA, a measure of anxiety sensitivity specific to cardiovascular patients. The CAQ conceptualizes HFA as a 3 dimensional measure, including heart-related fear, avoidance, attention subscales.
Time frame: 16 Weeks
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