Tension Tamer Randomized Control Trial
Condition: Pre-hypertension
MeSH terms: Prehypertension
Study type: Interventional

Summary: 
      This study is 12 months long and consists of 5 visits at baseline, months 1, 3, 6, and 12. To
      determine eligibility potential subjects will have resting blood pressures (BP) measured on 2
      occasions. Pre-hypertensive individuals will be invited to participate in the study. After
      informed consent is obtained, subjects will complete baseline visit consisting of a survey,
      resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours,
      collect saliva and urine samples. Subjects will then be randomly assigned to Tension Tamer
      (TT) or lifestyle education program delivered via smartphone (SPCTL) groups. At the remaining
      4 visits subjects will again complete a survey, resting BP, wear activity watch for 7 days
      ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Throughout
      the 12 months TT group will meditate twice daily and SPCTL group will log physical activity.
    

Detailed description: 
      80 stage 1 or 2 pre-hypertensive adults, will be randomly assigned to 2x daily TT at
      scheduled decreasing doses or enhanced standard of care lifestyle education program delivered
      via smartphone (SPCTL) for 12 months. Subjects will participate in 5 study visits at
      baseline/enrollment, 1, 3, 6 , and 12 months

      TT subjects will be given the TT app. The app provides instructions on breathing awareness
      meditation (BAM): focusing upon the moment by sustaining one's attention upon diaphragm
      movements and related sensations while breathing in a slow, deep, relaxed manner. One learns
      to passively observe thoughts, images and extraneous sounds without making judgments about
      them. BAM doesn't involve analysis of historical or recent stressful experiences, but instead
      centers upon learning to stay in the present moment while meditating. The app will also
      collect heart rate (HR) values during each session using the phone's camera. The duration of
      the TT sessions will begin at 15 min., decrease to 10 min., and finally decrease to 5 min.
      Adherence will be monitored by the receipt of date-stamped heart rate values collected during
      each meditation session.

      SPCTL subjects will be provided Runkeeper app and taught how to record physical activity they
      perform. Recommended dosage of using SPCTL media and/or app will be that of the TT group.
      Adherence to SPCTL will be assessed using server file analyses of modules used and activity
      recorded in Runkeeper.
    

Intervention name(s): Tension Tamer (TT); Lifestyle education program (SPCTL)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Tension Tamer is an app that provides training and motivation for breathing awareness meditation (BAM). The app also tracks heart rate values during each session by placing a finger tip over the rear camera.; SPCTL group will use Runkeeper app to log physical activity. They will also receive text messages with short healthy lifestyle tips, and links to media with pamphlets or videos with more in-depth information.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Breathing Awareness Meditation,