Self-Directed Biological Transformation Initiative
Condition: Healthy
Study type: Interventional

Summary: 
      It is becoming increasingly recognized in the literature that ancient practices for
      wellbeing, including meditation, yoga, and specific herbs, can improve health and promote
      longevity. While studies have documented such effects for a variety of individual practices
      for wellbeing, few studies have taken a more whole systems approach that is simultaneously
      inclusive of numerous practices. This intervention study, the "Self-Directed Biological
      Transformation Initiative", will examine the effects of a comprehensive whole systems
      approach to wellbeing on key biochemical, physiological, and psychosocial endpoints.
      Participants randomized to the Perfect Health program at the Chopra Center for Wellbeing will
      be compared to individuals not taking the program.
    

Detailed description: 
      SPECIFIC AIMS

        1. To examine the effects of the Self-Directed Biological Transformation Initiative (SBTI)
           course participants compared to control group participants on key biochemical and
           physiological markers.

        2. To examine the effects of the SBTI course participants compared to control group
           participants on short- and long-term changes in heart rate variability, level of
           activity, and sleep quality.

        3. To examine the effects of the SBTI course participants as compared to control group
           participants on mood and wellbeing.

      BACKGROUND AND SIGNIFICANCE It has long been thought that ancient practices can promote
      longevity and wellbeing but there is little empirical evidence and it is difficult to test
      this under controlled or experimental conditions. Recently, however, there have been several
      cellular-based markers that may index rate of biological aging. The rate of telomere
      shortening, as indexed by change in telomere length and telomerase activity, predicts both
      cellular and human longevity (Lin et al, 2012). It is related to malleable factors, lifestyle
      and psychological state (Puterman & Epel, 2012). A secondary measure that shows promise of
      understanding rate of cellular aging is examination of gene expression, particularly genes
      related to aging. Preliminary evidence suggests that mind-body practices may slow the rate of
      cellular aging by improving the telomere/telomerase maintenance system. This has been
      examined in four small studies so far.

      In the first study of its kind, a four month intensive lifestyle modification program,
      including yoga and group support was associated with an increase in telomerase in 39 men with
      prostate cancer (in preparation). There was no control group in this study. However, those
      with the greatest decreases in distressing thoughts about having cancer showed the biggest
      increases in telomerase activity (Ornish et al, 2008). In a second study, healthy men and
      women were randomized to a 3-month intensive in-residence meditation group or wait list
      control group. The researchers examined telomerase only post intervention and found that the
      meditation group had 30% higher telomerase, and further increases in wellbeing were
      associated with increases in telomerase (Jacobs et al, 2011). In another study with an active
      control group, examined 39 elderly high stress dementia caregivers. They randomized half the
      group to Yoga Nidra, listening to a 15 minute tape each day of Yoga Nidra, which includes
      instruction on breathing and hand movements and half to a control group which listened to a
      relaxation tape for 15 minutes each day. Eight weeks later, they found greater telomerase
      increases in the Yoga Nidra group, and across the sample, decreases in depressive symptoms
      were associated with increases in telomerase activity (Lavretsky et al, 2013).

      Similar studies have reported positive effects of such practices on inflammatory profiles and
      gene expression (Tang, Ma et al. 2009, Bhasin, Dusek et al. 2013, Saatcioglu 2013). Another
      well studied parameter for practices such as meditation and yoga is heart rate variability
      (HRV) as it provides a broad measure of autonomic nervous system activity. Observational
      studies report HRV to be associated with stress in the workplace,(Jarczok, Jarczok et al.
      2013) depressive and anxiety disorders (Gorman and Sloan 2000), and in individuals with
      chronic somatic complaints (Tak, Riese et al. 2009). Meditation and yoga interventions to
      improve HRV can lead to improved physiologic and clinical outcomes (Wheat and Larkin 2010,
      Papp, Lindfors et al. 2013). Other parameters can also be of potential benefit in evaluating
      an individual's overall wellbeing. For example, sleep duration and quality, as well as
      general activity levels can both contribute to and reflect overall wellbeing. To date,
      however, lack of compelling data around objective measures of wellbeing is in large part due
      to challenges associated with long term monitoring of monitoring of appropriate patient
      populations. However, recent advances in biosensor technologies have overcome this limitation
      and now allow for the non-obtrusive and passive monitoring of individuals for long periods of
      time. These new data streams of real-time physiologic data, couple with sophisticated and
      individualized data analytics can potentially identify novel measures of individual wellness,
      which will allow for the development of personalized therapeutic interventions to improve
      wellbeing.

      Overall, while the results of many of the studies of traditional practices are compelling, in
      reality, and according the more whole system approaches such as Ayurveda and Chines Medicine,
      traditional practices are rarely practiced singularly, i.e, typically yoga asanas are
      practiced with meditation as well as a form of pranayama (breathing). With this
      consideration, few scientific studies have taken a more comprehensive "whole systems"
      approach that is simultaneously inclusive of numerous practices. Regarding outcomes, this
      study will take a systems biology approach to examining the biochemical, physiological, and
      psychosocial effects of the intervention. It is anticipated that the findings will
      demonstrate the value of taking a more inclusive and comprehensive whole systems approach to
      improving wellbeing and improved health.
    

Intervention name(s): Perfect Health Course
Intervention type(s): Behavioral
Intervention description(s): The Perfect Health course as taught at the Chopra Center for Wellbeing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wellbeing; meditation; Ayurveda; yoga; herbs; health; longevity; individuals