NCT01784796|CompletedResults
Mindful Hearts Study: Mindfulness to Reduce Stress
Mindfulness Based Stress Reduction for Women at Risk for Cardiovascular Disease
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Mindfulness Based Stress Reduction for Women at Risk for Cardiovascular Disease
Sponsor study identifier
interventional
164
1 country
1
Study Start
July 1, 2013
Actual (reported)Primary Completion
July 1, 2017
Actual (reported)Study Completion
January 31, 2018
Actual (reported)The purpose of this study is to determine how a stress reduction program, called Mindfulness Based Stress Reduction (MBSR), compared to a health education program, improves well being and reduces the risk of heart disease in women Veterans. Recruitment completed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 4, 2013
Actual (reported)February 6, 2013
Actual (reported)July 1, 2013
Actual (reported)July 1, 2017
Actual (reported)January 31, 2018
Actual (reported)May 31, 2019
Actual (reported)Perceived Stress
Psychological stress measured with the Perceived Stress Scale (PSS). Total scores on the PSS range from 0 to 40 with higher scores indicating higher levels of perceived stress. Scores between 0 to 13 suggest low stress, scores between 14 and 26 suggest moderate stress, and scores between 27 and 40 indicate high perceived stress.
8 week
Depressive Symptoms
Depressive symptoms were measured with the CES-D Total scores for the CES-D range from 0 to 60 with higher scores indicating greater depressive symptoms.
8 week
Quality of Life (QOL)
Measured with Quality of Life Index-III Generic (QLI) Total scores for the QLI range from 0 to 30 with higher scores indicating better quality of life.
8 week Mindfulness Based Stress Reduction program
8 week Health Education program
8 week Mindfulness Based Stress Reduction Program
8 week Health Education Program
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000, United States
Levine GN, Lange RA, Bairey-Merz CN, Davidson RJ, Jamerson K, Mehta PK, Michos ED, Norris K, Ray IB, Saban KL, Shah T, Stein R, Smith SC Jr; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Council on Hypertension. Meditation and Cardiovascular Risk Reduction: A Scientific Statement From the American Heart Association. J Am Heart Assoc. 2017 Sep 28;6(10):e002218. doi: 10.1161/JAHA.117.002218.
Saban KL, Mathews HL, Bryant FB, Tell D, Joyce C, DeVon HA, Witek Janusek L. Perceived discrimination is associated with the inflammatory response to acute laboratory stress in women at risk for cardiovascular disease. Brain Behav Immun. 2018 Oct;73:625-632. doi: 10.1016/j.bbi.2018.07.010. Epub 2018 Jul 17.
Karen L. Saban, PhD RN
Edward Hines Jr. VA Hospital, Hines, IL
164 participants (actual enrollment reported by the registry).
First Submitted
February 4, 2013
First Posted
February 6, 2013
Study Start
July 1, 2013
Actual (reported)Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis
8 week
Cardiovascular Risk
6 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 1, 2017
Actual (reported)Study Completion
January 31, 2018
Actual (reported)Last Updated
September 16, 2021
Results First Posted
May 31, 2019
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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