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Mindful Hearts Study

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ClinicalTrials.gov Identifier: NCT01784796
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : March 5, 2018
Information provided by (Responsible Party):
VA Office of Research and Development

February 4, 2013
February 6, 2013
March 5, 2018
July 1, 2013
July 1, 2017   (Final data collection date for primary outcome measure)
Psychological stress [ Time Frame: 6 months ]
Psychological stress will be examined using standardized written questionnaires measuring perceived stress, anxiety, depressive symptoms, and anger
Psychological stress [ Time Frame: 6 months ]
Complete list of historical versions of study NCT01784796 on ClinicalTrials.gov Archive Site
Cardiovascular Risk [ Time Frame: 6 months ]
Cardiovascular risk as measured by Reynold's Risk Score and endothelial dysfunction
Same as current
Not Provided
Not Provided
Mindful Hearts Study
Mindfulness Based Stress Reduction for Women at Risk for Cardiovascular Disease
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.

Evidence demonstrates that chronic stress doubles the risk of myocardial infarction and contributes to proinflammatory processes implicated in coronary artery disease and stroke. Veterans who have experienced combat are at greater risk for cardiovascular disease (CVD) compared to noncombat Veterans and non-Veterans. However, previous research has focused primarily on male Veterans. Yet statistics reveal a startling number (81-92%) of women Veterans report at least one traumatic event sometime in their lives and women Veterans experience significant rates of prior life adversity such as sexual assault, physical violence, and combat exposure. Compelling evidence demonstrates a strong relationship between the breadth of prior life adversity, proinflammatory cytokines and stress-related inflammatory disease, such as CVD. Assisting women Veterans to reduce stress and develop coping strategies may improve psychological well-being and reduce CVD risk. Mindfulness Based Stress Reduction (MBSR) involves intensive training in mindfulness, which promotes positive adaptation to life stress. MBSR has been found to reduce symptoms of depression and improve quality of life in Veterans experiencing Post-Traumatic Stress Disorder (PTSD). Practitioners of MBSR gain increased awareness and insight into the relationship among their thoughts, emotions, and somatic reactivity which can facilitate change in conditioned patterns of emotional reaction. However, only minimal research and no randomized control trials (RCTs) have examined MBSR as an intervention for reducing CVD risk in women Veterans. Furthermore, previous studies have neither examined CVD risk objectively using a well-established CVD risk score nor measured endothelial dysfunction. Endothelial dysfunction is acknowledged to precede atherosclerosis and is a strong predictor of CVD. Furthermore, studies demonstrate that lifestyle changes, such exercise and yoga, can reverse endothelial dysfunction. However, no studies were found that considered endothelial function in relation to MBSR. Moreover, potential protective and risk factors, such as prior life adversity, social support, health behaviors, acculturation, and diurnal cortisol, posited to moderate the effect of psychological well-being and inflammation on MBSR have not been examined.

Women Veterans between the ages of 18 and 70 years who have at least one CVD risk factors (as defined by Framingham CVD Risk Scale) will be randomized into either an 8-week MBSR program or health education control program. The following specific aims will be addressed: (1) Determine the extent to which training in MBSR (1) improves psychological well-being, (2) decreases inflammatory burden, and (3) reduces cardiovascular risk in women Veterans; and (2) Evaluate protective and risk factors posited to moderate the effect of MBSR on psychological well being, inflammatory burden and cardiovascular risk in women Veterans. Age, body mass index (BMI), menstrual status, medications, and socioeconomic status (SES) will be evaluated as covariates. The proposed research is innovative in that MBSR has not been evaluated in women Veterans at risk for CVD. The investigators expect that MBSR will improve psychological well-being and reduce CVD risk with improvements sustained for at least 6 months. Given that CVD is a major cause of mortality, this research may have broader implications for reducing CVD in the general population.

Recruitment completed.

Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
  • Cardiovascular Disease
  • Psychological Stress
  • Stroke
  • Coronary Artery Disease
  • Behavioral: Mindfulness Based Stress Reduction
    8 week Mindfulness Based Stress Reduction Program
    Other Name: MBSR
  • Behavioral: Health Education Program
    8 week Health Education Program
    Other Name: Health Education
  • Experimental: Mindfulness Based Stress Reduction
    8 week Mindfulness Based Stress Reduction program
    Intervention: Behavioral: Mindfulness Based Stress Reduction
  • Active Comparator: Health education program
    8 week Health Education program
    Intervention: Behavioral: Health Education Program
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). pii: e002218. doi: 10.1161/JAHA.117.002218.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 31, 2018
July 1, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NRI 12-413
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Undecided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Karen L. Saban, PhD RN Edward Hines Jr. VA Hospital, Hines, IL
VA Office of Research and Development
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP