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Tension Tamer Randomized Control Trial

Sponsor
Medical University of South Carolina (Other)
Overall Status
Completed
CT.gov ID
NCT03168789
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
37.7
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tension Tamer (TT)
  • Behavioral: Lifestyle education program (SPCTL)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Smartphone Delivered Meditation for BP Control Among Prehypertensives
Actual Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Nov 22, 2019
Actual Study Completion Date :
Nov 22, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tension Tamer (TT)

Breathing Awareness Mediation delivered by smartphone app.

Behavioral: Tension Tamer (TT)
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.
Active Comparator: Lifestyle education program (SPCTL)

Healthy lifestyle education provided by text messages and links to media. Runkeeper app to log physical activity.

Behavioral: Lifestyle education program (SPCTL)
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.

Outcome Measures

Primary Outcome Measures

  1. Resting BP [12 months]

    Resting SBP reduction target -7 mmHg.

Secondary Outcome Measures

  1. Ambulatory SBP [12 months]

    24-hr SBP reduction target -4 mmHg.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. 18-90 years old, male or female, African American (AA) or White;

  2. Stage 1 or 2 pre-hypertensive (i.e., SBP 120-139/DBP<90) based upon 2 consecutive clinic evaluations;

  3. Body Mass Index (BMI) 18.5 -45 Kg/m2;

  4. legally competent;

  5. able to use a smart phone.

Exclusion Criteria:

  1. failure to meet any inclusion criteria;

  2. type two diabetes or chronic kidney disease (GFR<50 mL/1.7 m2/min.);

  3. cancer diagnosis or treatment in past 2 years;

  4. prior cardiovascular event, congestive heart failure or angina;

  5. prior or current psychiatric illness;

  6. ongoing substance abuse (e.g., >21 drinks/week);

  7. pharmacologic medications which may influence blood pressure (BP);

  8. planned pregnancy;

  9. vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425

Sponsors and Collaborators

  • Medical University of South Carolina

Investigators

  • Principal Investigator: Frank A Treiber, PhD, MUSC College of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Frank Treiber, Professor and Director TACHL, College of Nursing, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT03168789
Other Study ID Numbers:
  • Pro00020894
First Posted:
May 30, 2017
Last Update Posted:
Jan 14, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Frank Treiber, Professor and Director TACHL, College of Nursing, Medical University of South Carolina
Breathing Awareness Meditation,
Additional relevant MeSH terms:
Prehypertension

Study Results

No Results Posted as of Jan 14, 2020