Mindful Hearts Study
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Neurology, Psychiatric |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | July 1, 2013 |
| End Date: | January 31, 2018 |
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.
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.
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.
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
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