Mindful Hearts Study: Mindfulness to Reduce Stress
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|ClinicalTrials.gov Identifier: NCT01784796|
Recruitment Status : Completed
First Posted : February 6, 2013
Results First Posted : May 31, 2019
Last Update Posted : October 9, 2019
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01784796
|United States, Illinois|
|Edward Hines Jr. VA Hospital, Hines, IL|
|Hines, Illinois, United States, 60141-5000|
|Principal Investigator:||Karen L. Saban, PhD RN||Edward Hines Jr. VA Hospital, Hines, IL|