Mindful Hearts Study: Mindfulness to Reduce Stress

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01784796
• Collaborator: (none)
• Enrollment: 164
• Location: 1
• Arms: 2
• Actual Duration (Months): 55
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease; Psychological Stress; Stroke; Coronary Artery Disease	Behavioral: Mindfulness Based Stress Reduction; Behavioral: Health Education Program	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 164 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Mindfulness Based Stress Reduction for Women at Risk for Cardiovascular Disease
• Actual Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jan 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 Names: MBSR
Active Comparator: Health education program 8 week Health Education program	Behavioral: Health Education Program; 8 week Health Education Program; Other Names: Health Education

Outcome Measures

Primary Outcome Measures

1. Perceived Stress [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.

2. Depressive Symptoms [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.

3. Quality of Life (QOL) [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.

Secondary Outcome Measures

1. Cardiovascular Risk [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois	United States	60141-5000

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Karen L. Saban, PhD RN, Edward Hines Jr. VA Hospital, Hines, IL

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 29, 2016
• Informed Consent Form - Dec 14, 2016

More Information

Publications

• 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). pii: e002218. doi: 10.1161/JAHA.117.002218. Review.
• 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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01784796
• Other Study ID Numbers: NRI 12-413
• First Posted: Feb 6, 2013
• Last Update Posted: Sep 16, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: cardiovascular disease; women's health; psychological stress; Veterans; stroke
• Additional relevant MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Stress, Psychological

Study Results

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.

Arm/Group Title	Mindfulness Based Stress Reduction	Health Education Program
Arm/Group Description	8 week Mindfulness Based Stress Reduction program	8 week Health Education program Health Education Program: 8 week Health Education Program
Period Title: Overall Study
STARTED	87	77
Baseline Data Collected	75	61
4 Week Data Collection	48	41
8 wk Data Collection	50	46
COMPLETED	39	34
NOT COMPLETED	48	43

Baseline Characteristics

Arm/Group Title	Mindfulness Based Stress Reduction	Health Education Program	Total
Arm/Group Description	8 week Mindfulness Based Stress Reduction program Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program	8 week Health Education program Health Education Program: 8 week Health Education Program	Total of all reporting groups
Overall Participants	75	61	136
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	71 94.7%	59 96.7%	130 95.6%
>=65 years	4 5.3%	2 3.3%	6 4.4%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	50.83	50.51	50.75
Sex: Female, Male (Count of Participants)
Female	75 100%	61 100%	136 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 14.7%	07 11.5%	18 13.2%
Not Hispanic or Latino	64 85.3%	54 88.5%	118 86.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.3%	1 1.6%	2 1.5%
Asian	0 0%	1 1.6%	1 0.7%
Native Hawaiian or Other Pacific Islander	1 1.3%	1 1.6%	2 1.5%
Black or African American	29 38.7%	26 42.6%	55 40.4%
White	42 56%	30 49.2%	72 52.9%
More than one race	1 1.3%	2 3.3%	3 2.2%
Unknown or Not Reported	1 1.3%	0 0%	1 0.7%
Region of Enrollment (Count of Participants)
United States	75 100%	61 100%	136 100%
Center for Epidemiological Studies Depression Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	22.78 (13.76)	19.22 (11.67)	21.17 (13.00)
Perceived Stress Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	19.64 (8.21)	17.50 (7.52)	18.70 (8.00)
Quality of Life Index (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	17.96 (6.29)	19.16 (5.39)	18.70 (6.30)

Outcome Measures

1. Primary Outcome

Title	Perceived Stress
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Mindfulness Based Stress Reduction	Health Education Program
Arm/Group Description	8 week Mindfulness Based Stress Reduction program Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program	8 week Health Education program Health Education Program: 8 week Health Education Program
Measure Participants	50	46
Mean (Standard Deviation) [score on a scale]	15.94 (8.53)	15.50 (7.33)

2. Primary Outcome

Title	Depressive Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness Based Stress Reduction	Health Education Program
Arm/Group Description	8 week Mindfulness Based Stress Reduction program Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program	8 week Health Education program Health Education Program: 8 week Health Education Program
Measure Participants	50	46
Mean (Standard Deviation) [score on a scale]	18.38 (13.26)	14.46 (11.03)

3. Primary Outcome

Title	Quality of Life (QOL)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness Based Stress Reduction	Health Education Program
Arm/Group Description	8 week Mindfulness Based Stress Reduction program	8 week Health Education program Health Education Program: 8 week Health Education Program
Measure Participants	50	46
Mean (Standard Deviation) [score on a scale]	19.77 (5.81)	19.46 (5.00)

4. Secondary Outcome

Title	Cardiovascular Risk
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness Based Stress Reduction	Health Education Program
Arm/Group Description	8 week Mindfulness Based Stress Reduction program Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program	8 week Health Education program Health Education Program: 8 week Health Education Program
Measure Participants	39	34
Mean (Standard Deviation) [score on a scale]	4.77 (3.16)	5.80 (4.83)

Adverse Events

Time Frame	Duration of study and follow up - which was 6 months
Arm/Group Title	Mindfulness Based Stress Reduction		Health Education Program
Arm/Group Description	8 week Mindfulness Based Stress Reduction program Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program		8 week Health Education program Health Education Program: 8 week Health Education Program
All Cause Mortality
	Mindfulness Based Stress Reduction		Health Education Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/61 (0%)
Serious Adverse Events
	Mindfulness Based Stress Reduction		Health Education Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/61 (0%)
Other (Not Including Serious) Adverse Events
	Mindfulness Based Stress Reduction		Health Education Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/75 (1.3%)		0/61 (0%)
Gastrointestinal disorders
Hospitalization	1/75 (1.3%)	1	0/61 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.