Mindful Hearts Study: Mindfulness to Reduce Stress

NCT01784796 | Completed Results

• 1 other identifier: NRI 12-413
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Psychological Stress; Stroke; Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  8 week

Secondary Outcomes (1)

• Cardiovascular Risk

  6 months

Study Arms (2)

Mindfulness Based Stress Reduction

EXPERIMENTAL

8 week Mindfulness Based Stress Reduction program

Behavioral: Mindfulness Based Stress Reduction

Health education program

ACTIVE COMPARATOR

8 week Health Education program

Behavioral: Health Education Program

Interventions

Mindfulness Based Stress Reduction BEHAVIORAL

8 week Mindfulness Based Stress Reduction Program

Also known as: MBSR

Mindfulness Based Stress Reduction

Health Education Program BEHAVIORAL

8 week Health Education Program

Also known as: Health Education

Health education program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Related Publications (2)

• 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.

  PMID: 28963100 BACKGROUND

• 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.

  PMID: 30012518 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Stress, Psychological; Stroke; Coronary Artery Disease

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Karen Saban, PhD
• Organization: Edward Hines VA Hospital

Karen.Saban@va.gov

708-202-5264

Study Officials

• Karen L. Saban, PhD RN

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 6, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: January 31, 2018
• Last Updated: September 16, 2021
• Results First Posted: May 31, 2019

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)