Atrial Fibrillation, Cardiovascular Risk Reduction, Hypertension, Mindfulness
Conditions
Brief summary
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.
Interventions
BEHAVIORALMindfulness-based coaching
16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.
BEHAVIORALDietary cardiovascular risk reduction coaching
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.
Sponsors
Southlake Regional Health Centre
York University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 50-80 * Diagnosed Atrial Fibrillation * Night time (Sleep Time) Systolic Blood Pressure≥120 OR Daytime (awake) Systolic Blood Pressure ≥ 135 * Able and Willing to sign Informed Consent Form
Exclusion criteria
* Scheduled for Surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Night time (Sleep) Systolic Blood Pressure | 16 weeks | The primary outcome of this study will be change in ANBP from baseline when compared to subsequent follow-up study time points. |
| Daytime time (Awake) Systolic Blood Pressure | 16 Weeks | The primary outcome of this study will be change in daytime ABP from baseline when compared to subsequent follow-up study time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) | 16 Weeks | 14 item self-report questionnaire evaluating anxiety and depression symptoms in medical populations |
| Profile of Mood States (POMS-SF) | 16 Weeks | 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 |
| Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) | 16 Weeks | 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. |
| Nocturnal Dipping | 16 Weeks | ANBP will be calculated as the percentage of nocturnal drop in systolic blood pressure in relation to its daytime values |
| Pittsburgh Sleep Quality Index (PSQI) | 16 Weeks | 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. |
| Cardiac Anxiety Questionnaire (CAQ) | 16 Weeks | 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. |
| SF-12 v2 Health Survey | 16 Weeks | 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). |
| Atrial Tachyarrhythmia Episodes | 16 Weeks | 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 |
Countries
Canada
Contacts
Primary ContactPaul Ritvo, Ph.D
Outcome results
None listed