Mindfulness-Based Stress Reduction and Myocardial Ischemia

NCT00224835 | Completed DMC

• 2 other identifiers: 319R01HL072059
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The principal objective of the study is to evaluate the effectiveness of a widely used complementary medicine intervention, mindfulness-based stress reduction (MBSR), in which mindfulness meditation and yoga are the principal components in the treatment of a chronic, often fatal illness that affects tens of millions of Americans. The investigators propose to conduct a single center randomized controlled trial in which 150 patients will be assigned to either a mindfulness meditation condition, a disease education control condition, or a stress-monitoring usual care control condition. They will test the following specific hypotheses:

1. 1.In comparison to either of the control conditions, significantly more coronary artery disease (CAD) patients in the mindfulness meditation condition will demonstrate reductions in mental stress-induced ischemia.
2. 2.The ratio of low-to-high frequency of spectral power in heart rate variability during ambulatory monitoring will be significantly decreased following the participation in a stress reduction program compared with those in a disease education or usual care condition.
3. 3.Patients in the mindfulness meditation condition will report greater improvement in quality of life (i.e., reductions in general psychological symptomology, anger, anxiety, depression, and daily stress, along with increases in optimism and stress coping efficacy) than patients in either of the control conditions.
4. 4.Day-to-day variability in self-reported mental stress will be inversely related to day-to-day stress coping efficacy in the entire sample and time spent in mindfulness practice in the active treatment condition, and these relationships will be maintained over a 3-month follow-up.
5. 5.Patients with CAD and mental stress ischemia who show an \*abnormal peripheral artery response during baseline studies will show a significant improvement after mindfulness intervention.
6. 6.Abnormal responses will be defined as peripheral arterial tonometry (PAT) tracings that decrease greater than 20% in amplitude during mental stress.

Conditions

Arteriosclerosis

Outcome Measures

Primary Outcomes (5)

• Psychological stress-induced ischemia (measured by radionuclide imaging at Week 9)

  After data collection is complete.

• Heart rate variability (measured by AECG at Week 9)

  After data collection is complete

• Peripheral artery response (measured by finger plethysmography at Week 9)

  After data collection is complete

• Psychological functioning (degree of depression measured by Beck Depression Inventory (BDI), anxiety by STAI, hostility by Cook-Medley Index, anger by STAXI, optimism by LOT-R, and quality of life/functional status by SF-36 at Weeks 9 and 20)

  Results of BDI will be assessed immediately after the participant completes the form. All other questionnaires will be assessed after data collection is complete.

• Daily mood diaries (obtained at Weeks 7-8 and Weeks 20-21)

  After data collection is complete

Study Arms (2)

1

EXPERIMENTAL

Mindfulness Based Stress Reduction Class

Behavioral: Mindfulness Based Stress Reduction Class

2

EXPERIMENTAL

Cardiac Education Class

Behavioral: Cardiac Education Class

Interventions

Mindfulness Based Stress Reduction Class BEHAVIORAL

Subjects randomized to this condition will attend 120 minute weekly sessions, plus a 7 hour retreat, for training in mindfulness meditation methods.

1

Cardiac Education Class BEHAVIORAL

Subjects in the disease education control condition will attend 8 weekly 60 minute sessions, plus a 7 hour "special experience" session, all of which will provide information about CAD in a didactic format.

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Confirmed CAD--the clinical diagnosis of coronary disease will be defined by the presence of at least one of the following: 1) abnormal coronary angiogram; 2) abnormal intravascular ultrasound (IVUS); or 3) abnormal flow reserve and documentation of one of the following: 1) elevated troponin laboratory values typical for myocardial infarction; 2) electrocardiogram (ECG) that shows q-wave abnormalities; 3) nuclear scan that demonstrates a fixed wall motion abnormality consistent with an old myocardial infarct; 4) greater than 95% probability of coronary disease according to the criteria of Diamond and Forrester.102; 5) radionuclide study, dobutamine, or exercise echocardiographic study consistent with stress-induced ischemia (development of segmental wall motion abnormalities or reversible perfusion defects on radionuclide imaging and/or wall motion or systolic thickening abnormalities on stress echocardiographic exam)

You may not qualify if:

• Current pregnancy or probability of pregnancy during the duration of the 12-week study
• Diagnosis of unstable angina in the prior 2 months
• Presence of other severe, complicating medical problems that will significantly shorten the patients' life expectancy such that they will not be expected to live for the 12 weeks of this study
• Presence of serious psychopathology evidenced by BDI scores that indicate a clinically critical level of depression (score of 24 or above) with suicidal ideation; previous diagnosis of an organic mental disorder, schizophrenia, or any psychotic disorder; or psychiatric inpatient at any time during the last 5 years (if patients are excluded on the basis of depression scores indicating severe depression or suicidal ideation, referral for psychological services will be offered)
• Post-traumatic stress disorder (PTSD) greater than the 30% VA disability assignment (patients with less severe PTSD will be encouraged to participate)
• Existing meditation practice
• Weight more than 400 pounds

Sponsors & Collaborators

• University of Florida: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Arteriosclerosis

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David S Sheps, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: May 1, 2003
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

US (1)