N/A N=164 Randomized Single-blind Prevention

Mindful Hearts Study: Mindfulness to Reduce Stress

Cardiovascular Disease · Psychological Stress · Stroke · Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT01784796 ↗

Enrolled (actual)

164

Serious AEs

0.0%

Results posted

May 2019

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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mindfulness Based Stress Reduction (Behavioral); Health Education Program (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: VA Office of Research and Development
Primary completion: Jul 2017

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	—

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.

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.