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Completed

NCT Number: NCT01784796

Mindful Hearts Study: Mindfulness to Reduce Stress

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Based Stress Reduction

Behavioral

8 week Mindfulness Based Stress Reduction Program

Other names: MBSR

Health Education Program

Behavioral

8 week Health Education Program

Other names: Health Education

Primary outcomes

  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 outcomes

  1. Cardiovascular Risk

    Time frame: 6 months

    Cardiovascular risk as measured by Reynolds Risk Score. The Reynolds 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Mindfulness Based Stress Reduction for Women at Risk for Cardiovascular Disease

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Feb 6, 2013
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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