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Mindful Hearts Study: Mindfulness to Reduce Stress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01784796
Recruitment Status : Completed
First Posted : February 6, 2013
Results First Posted : May 31, 2019
Last Update Posted : October 9, 2019
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Psychological Stress Stroke Coronary Artery Disease Behavioral: Mindfulness Based Stress Reduction Behavioral: Health Education Program Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Mindfulness Based Stress Reduction for Women at Risk for Cardiovascular Disease
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : January 31, 2018

Arm Intervention/treatment
Experimental: Mindfulness Based Stress Reduction
8 week Mindfulness Based Stress Reduction program
Behavioral: Mindfulness Based Stress Reduction
8 week Mindfulness Based Stress Reduction Program
Other Name: MBSR

Active Comparator: Health education program
8 week Health Education program
Behavioral: Health Education Program
8 week Health Education Program
Other Name: Health Education

Primary Outcome Measures :
  1. Perceived Stress [ Time Frame: 8 week ]

    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.

  2. Depressive Symptoms [ Time Frame: 8 week ]

    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.

  3. Quality of Life (QOL) [ Time Frame: 8 week ]

    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.

Secondary Outcome Measures :
  1. Cardiovascular Risk [ Time Frame: 6 months ]
    Cardiovascular risk as measured by Reynold's Risk Score. The Reynold's Cardiovascular Risk score predicts the percent risk of having a heart attack, stroke or other major heart disease in the next 10 years. Scores range from 0 to 100% with higher scores representing greater risk of developing cardiovascular disease in 10 years.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01784796

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United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Karen L. Saban, PhD RN Edward Hines Jr. VA Hospital, Hines, IL
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Informed Consent Form  [PDF] December 14, 2016

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Responsible Party: VA Office of Research and Development Identifier: NCT01784796     History of Changes
Other Study ID Numbers: NRI 12-413
First Posted: February 6, 2013    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: October 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
cardiovascular disease
women's health
psychological stress
Additional relevant MeSH terms:
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Coronary Artery Disease
Stress, Psychological
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arterial Occlusive Diseases
Behavioral Symptoms