Trial record 16 of 906 for:    coronary heart disease OR heart disease OR coronary artery disease OR atherosclerosis | Open Studies | NIH, U.S. Fed

Mindful Hearts Study

This study is currently recruiting participants.
Verified December 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01784796
First received: February 4, 2013
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Psychological Stress
Stroke
Coronary Artery Disease
Behavioral: Mindfulness Based Stress Reduction
Behavioral: Health Education Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Mindfulness Based Stress Reduction for Women at Risk for Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Psychological stress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Psychological stress will be examined using standardized written questionnaires measuring perceived stress, anxiety, depressive symptoms, and anger


Secondary Outcome Measures:
  • Cardiovascular Risk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cardiovascular risk as measured by Reynold's Risk Score and endothelial dysfunction


Estimated Enrollment: 138
Study Start Date: July 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 35 and 70 years who have at least two 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. We 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between the ages of 18 and 70
  • 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
  • smoked within the past month
  • any immune-related disease
  • use of immune-altering medications, such as:

    • glucocorticoids
  • cancer
  • active infection
  • substance abuse
  • diagnosed with PTSD
  • major depressive disorder
  • or other major psychoses
  • already trained in MBSR
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784796

Contacts
Contact: Karen L Saban, PhD RN (708) 202-5264 karen.saban@va.gov
Contact: Deirdre C Murphy (708) 202-8387 ext 22320 Deirdre.Murphy@va.gov

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital Recruiting
Hines, Illinois, United States, 60141-5000
Contact: Karen L Saban, PhD RN    708-202-5264    karen.saban@va.gov   
Sub-Investigator: Carol Kostovich, MS PhD RN         
Sub-Investigator: Eileen G. Collins, PhD RN         
Sub-Investigator: Herb Mathews         
Principal Investigator: Karen L. Saban, PhD RN         
Sub-Investigator: Linda Janusek         
Sub-Investigator: Sudha Bhoopalam         
Sponsors and Collaborators
Investigators
Principal Investigator: Karen L. Saban, PhD RN Edward Hines Jr. VA Hospital
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01784796     History of Changes
Other Study ID Numbers: NRI 12-413
Study First Received: February 4, 2013
Last Updated: December 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
cardiovascular disease
women's health
psychological stress
Veterans
stroke

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stress, Psychological
Stroke
Arteriosclerosis
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 14, 2014