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Mindful Hearts Study: Mindfulness to Reduce Stress

Mindfulness Based Stress Reduction for Women at Risk for Cardiovascular Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01784796
Enrollment
164
Registered
2013-02-06
Start date
2013-07-01
Completion date
2018-01-31
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Coronary Artery Disease, Psychological Stress, Stroke

Keywords

cardiovascular disease, women's health, psychological stress, Veterans, stroke

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.

Interventions

BEHAVIORALMindfulness Based Stress Reduction

8 week Mindfulness Based Stress Reduction Program

BEHAVIORALHealth Education Program

8 week Health Education Program

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Perceived Stress8 weekPsychological 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 Symptoms8 weekDepressive 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)8 weekMeasured 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

MeasureTime frameDescription
Cardiovascular Risk6 monthsCardiovascular 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.

Countries

United States

Participant flow

Recruitment details

We had powered the study for a total of 110 participants (55 in each group). To account for attrition, we planned on recruiting a total of 138 participants (69 in each group). We enrolled 164 participants and 136 of these completed baseline data.

Participants by arm

ArmCount
Mindfulness Based Stress Reduction
8 week Mindfulness Based Stress Reduction program Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program
75
Health Education Program
8 week Health Education program Health Education Program: 8 week Health Education Program
61
Total136

Baseline characteristics

CharacteristicMindfulness Based Stress ReductionHealth Education ProgramTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants2 Participants6 Participants
Age, Categorical
Between 18 and 65 years
71 Participants59 Participants130 Participants
Age, Continuous50.83 years50.51 years50.75 years
Center for Epidemiological Studies Depression Scale22.78 units on a scale
STANDARD_DEVIATION 13.76
19.22 units on a scale
STANDARD_DEVIATION 11.67
21.17 units on a scale
STANDARD_DEVIATION 13
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants07 Participants18 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
64 Participants54 Participants118 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Perceived Stress Scale19.64 units on a scale
STANDARD_DEVIATION 8.21
17.50 units on a scale
STANDARD_DEVIATION 7.52
18.70 units on a scale
STANDARD_DEVIATION 8
Quality of Life Index17.96 units on a scale
STANDARD_DEVIATION 6.29
19.16 units on a scale
STANDARD_DEVIATION 5.39
18.70 units on a scale
STANDARD_DEVIATION 6.3
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
29 Participants26 Participants55 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
42 Participants30 Participants72 Participants
Region of Enrollment
United States
75 Participants61 Participants136 Participants
Sex: Female, Male
Female
75 Participants61 Participants136 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 750 / 61
other
Total, other adverse events
1 / 750 / 61
serious
Total, serious adverse events
0 / 750 / 61

Outcome results

Primary

Depressive Symptoms

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.

Time frame: 8 week

ArmMeasureValue (MEAN)Dispersion
Mindfulness Based Stress ReductionDepressive Symptoms18.38 score on a scaleStandard Deviation 13.26
Health Education ProgramDepressive Symptoms14.46 score on a scaleStandard Deviation 11.03
Primary

Perceived Stress

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.

Time frame: 8 week

Population: Baseline data was compared to 8 week data (completion of program) for both the MBSR and HEP groups.

ArmMeasureValue (MEAN)Dispersion
Mindfulness Based Stress ReductionPerceived Stress15.94 score on a scaleStandard Deviation 8.53
Health Education ProgramPerceived Stress15.50 score on a scaleStandard Deviation 7.33
Primary

Quality of Life (QOL)

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.

Time frame: 8 week

ArmMeasureValue (MEAN)Dispersion
Mindfulness Based Stress ReductionQuality of Life (QOL)19.77 score on a scaleStandard Deviation 5.81
Health Education ProgramQuality of Life (QOL)19.46 score on a scaleStandard Deviation 5
Secondary

Cardiovascular Risk

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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Mindfulness Based Stress ReductionCardiovascular Risk4.77 score on a scaleStandard Deviation 3.16
Health Education ProgramCardiovascular Risk5.80 score on a scaleStandard Deviation 4.83

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026