Depression Clinical Trial
Official title:
Effects of Mindfulness and Yoga on Heart Rate Variability and Immune Markers
In this study, we will conduct a preliminary, yet comprehensive evaluation of Mindfulness
and Yoga, as compared to an exercise and education-based stress-reduction program. and
simultaneous evaluation of the effect of an 8 week program of Mindfulness, 12 weeks of Yoga
practice, and 12 weeks of an exercise and education-based program.
105 otherwise healthy individuals, who have cardiovascular risk factors and mild to moderate
stress or anxiety will be randomly assigned to one of the three intervention groups: an 8
week program of Mindfulness, 12 week program of Yoga practice, and 12 week exercise and
education-based group program. All subjects will perform daily practice that will continue
after the weekly sessions end, allowing a follow up assessment at 24 weeks. Self-reported
mood and psychological distress and physiological indicators of function of the ANS and
stress hormones will be assessed at baseline, 8 weeks, 12 weeks and 24 weeks. Blood and
urine samples will be collected at baseline and 8 weeks to determine levels inflammatory and
atherosclerosis markers.
We anticipate that the study will provide information on the efficacy of the Mindfulness and
Yoga interventions as stress-reduction practices, variability in potential markers for
activation of the brain/cardiovascular system connections, and preliminary estimates of
effect size for each of these markers. Thus, the study will provide the data needed for
designing a future study that will rigorously address these questions in a larger,
randomized trial of Mindfulness and Yoga in patients with cardiovascular risk.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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