Cardiovascular DiseaseNCT01784796
Mindful Hearts Study: Mindfulness to Reduce Stress
A study testing Mindfulness Based Stress Reduction and Health Education Program in people with Cardiovascular Disease and Psychological Stress, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Psychological Stress, Stroke
- What is being tested?
- Mindfulness Based Stress Reduction and Health Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2013to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18
- Female Veteran
- Able to
- write
- read
- speak English
Show all 13Show fewer
- 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
Who cannot join
- History of:
- myocardial infarction or ischemic heart disease/angina
- left ventricular hypertrophy
- ischemic stroke
- pregnant
- planning on becoming pregnant during study period
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
About this study
Official title: Mindfulness Based Stress Reduction for Women at Risk for Cardiovascular Disease
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.
Read the 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.
- Being tested
- Mindfulness Based Stress Reduction, Health Education Program
- Keywords
- cardiovascular disease, women's health, psychological stress, Veterans, stroke
- Medical subject headings
- Cardiovascular Diseases, Stress, Psychological, Stroke, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress ReductionBehavioural
Also called MBSR
8 week Mindfulness Based Stress Reduction Program
Health Education ProgramBehavioural
Also called Health Education
8 week Health Education Program
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction | Experimental | 8 week Mindfulness Based Stress Reduction program Receives: Behavioral: Mindfulness Based Stress Reduction |
| Health education program | Active comparator | 8 week Health Education program Receives: Behavioral: Health Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 week
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.
Measured: 8 week
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.
Measured: 8 week
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study start1 Jul 2013
- Primary completion1 Jul 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Karen L. Saban, PhD RN, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784796
- Sponsor's protocol ID
- NRI 12-413
- Status last verified
- Aug 2021
- First submitted
- 4 Feb 2013
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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):e002218. doi: 10.1161/JAHA.117.002218.
PubMed 28963100Saban 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.
PubMed 30012518
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Stress Reduction for Women at Risk for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01784796
- Acronym / sponsor ID
- NRI 12-413
- Keywords
- cardiovascular disease, women's health, psychological stress, Veterans, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress Reduction | Experimental | Behavioral: Mindfulness Based Stress Reduction8 week Mindfulness Based Stress Reduction program |
| Health education program | Active comparator | Behavioral: Health Education Program8 week Health Education program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Between the ages of 18
- Female Veteran
- Able to
- BMI > 25
- Total cholesterol > 240
Key exclusion criteria (15 listed)
- History of:
- pregnant
- planning on becoming pregnant during study period
- gave birth in prior 6 weeks or lactating
- immune-related disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress ReductionAlso: MBSR8 week Mindfulness Based Stress Reduction Program | Behavioural | Mindfulness Based Stress Reduction |
| Health Education ProgramAlso: Health Education8 week Health Education Program | Behavioural | Health education program |
Primary outcome
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.
1 secondary outcome
Cardiovascular Risk
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28963100Levine 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.
- Background: PubMed 30012518Saban 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen L. Saban, PhD RN principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction and Health Education Program in people with Cardiovascular Disease and Psychological Stress, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress (time frame: 8 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01784796, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.