N/A Completed N=164 Randomized Single-blind Prevention

Mindful Hearts Study: Mindfulness to Reduce Stress

Cardiovascular Disease · Psychological Stress · Stroke · Coronary Artery Disease

Source: ClinicalTrials.gov NCT01784796 ↗

Enrolled (actual)

164

Serious AEs

0.0%

Results posted

May 2019

Primary outcomePrimary: Perceived Stress — 15.94; 15.50 score on a scale

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Perceived Stress	15.94; 15.50	—
PRIMARY Depressive Symptoms	18.38; 14.46	—
PRIMARY Quality of Life (QOL)	19.77; 19.46	—
SECONDARY Cardiovascular Risk	4.77; 5.80	—

Eligibility Criteria

Inclusion Criteria

Between the ages of 18
Female Veteran
Able to
write
read
speak English

Must have ONE of ANY of the following:

BMI > 25
Total cholesterol > 240
Diabetes mellitus or pre-diabetic
Systolic blood pressure> 120 and/or diagnosis of hypertension and/or taking antihypertensive medications
Parental history of MI prior to age 60
History of smoking

Exclusion Criteria

History of:
myocardial infarction or ischemic heart disease/angina
left ventricular hypertrophy
ischemic stroke
pregnant
planning on becoming pregnant during study period
gave birth in prior 6 weeks or lactating
immune-related disease
use of immune-altering medications, such as:
glucocorticoids
cancer
active infection
substance abuse
major psychoses
already trained in MBSR

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01784796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.