Mindful Hearts Study: Mindfulness to Reduce Stress

NCT ID: NCT01784796

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-01
• Study Completion Date: 2018-01-31

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.

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.

Conditions

Cardiovascular Disease; Psychological Stress; Stroke; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Mindfulness Based Stress Reduction

8 week Mindfulness Based Stress Reduction program

Group Type: EXPERIMENTAL

Mindfulness Based Stress Reduction

Intervention Type: BEHAVIORAL

8 week Mindfulness Based Stress Reduction Program

Health education program

8 week Health Education program

Group Type: ACTIVE_COMPARATOR

Health Education Program

Intervention Type: BEHAVIORAL

8 week Health Education Program

Interventions

Mindfulness Based Stress Reduction

8 week Mindfulness Based Stress Reduction Program

Intervention Type: BEHAVIORAL

Health Education Program

8 week Health Education Program

Intervention Type: BEHAVIORAL

Other Intervention Names

MBSR; Health Education

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen L. Saban, PhD RN

Role: PRINCIPAL_INVESTIGATOR

Edward Hines Jr. VA Hospital, Hines, IL

Locations

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Countries

United States

References

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):e002218. doi: 10.1161/JAHA.117.002218.

Reference Type: BACKGROUND

PMID: 28963100 (View on PubMed)

Saban KL, Mathews HL, Bryant FB, Tell D, Joyce C, DeVon HA, Witek Janusek L. Perceived discrimination is associated with the inflammatory response to acute laboratory stress in women at risk for cardiovascular disease. Brain Behav Immun. 2018 Oct;73:625-632. doi: 10.1016/j.bbi.2018.07.010. Epub 2018 Jul 17.

Reference Type: BACKGROUND

PMID: 30012518 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NRI 12-413

Identifier Type: -

Identifier Source: org_study_id