A New Translational Tool for Studying the Role of Breathing in Meditation
|ClinicalTrials.gov Identifier: NCT01264627|
Recruitment Status : Completed
First Posted : December 22, 2010
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: Mindful Breathing (MB) Intervention Behavioral: Usual Care (UC) Control Condition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Project Inspire: A New Translational Tool for Studying the Role of Breathing in Meditation|
|Actual Study Start Date :||February 1, 2011|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||August 31, 2017|
Experimental: Mindful Breathing (MB)
The MB intervention is based off of the Mindfulness Based Stress Reduction Program developed by Jon Kabat-Zinn. Participants will be organized into cohorts of eight, and attend eight weekly MB sessions. Mindful breathing consists of closely "following the breath," throughout inhalation and exhalation, sustaining moment-to-moment awareness on the breathing process, and passively observing thoughts, affective states, perceptions and events, from a non-evaluative, non-judgmental perspective. No other intervention is included. No FDA drug or device is involved.
Behavioral: Mindful Breathing (MB) Intervention
The Mindful Breathing (MB)intervention is based on MBSR developed by Jon Kabat-Zinn. Participants will attend 8 individual weekly MB sessions. MB consists of closely "following the breath," throughout inhalation and exhalation, sustaining moment-to-moment awareness on the breathing process, and passively observing thoughts, affective states, from a non-evaluative or judgmental perspective. As attention wanders to concerns or thoughts, participants will be instructed to acknowledge and accept these without evaluation and return the focus of attention back to breathing. Participants in MB will have their breathing rate and PetCO2 monitored during the 8 training sessions with a breathing monitor.
Usual Care (UC)
Usual Care consists of the standard care made available to participants through their primary physician. No intervention is included. No FDA drug or device is involved.
Behavioral: Usual Care (UC) Control Condition
This control intervention is designed to account for the effects of nonspecific factors such as enrollment in a study to enhance health with the associated expectancy effects, staff attention, and measurement procedures including the monitoring of PetCO2 and (Blood Pressure) BP, and completion of questionnaires. Participants who are randomly assigned to the Usual Care condition will receive care as usual for the management of their prehypertensive condition. UC participants will receive their usual care and have access to all Kaiser Permanente (KP) health education resources, such as KP's interactive healthcare guide, and online "Healthy Lifestyle Programs". We will assess the extent to which participants in both MB and UC used these resources.
- Blood Pressure [ Time Frame: Up to Week 25 ]Measured using Ambulatory, 24-Hr BP monitor
- Clinic (resting) blood pressure [ Time Frame: Up to Week 25 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264627
|Principal Investigator:||Margaret A Chesney, PhD||University of California, San Francisco|