Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
64 participants
INTERVENTIONAL
2008-06-30
2009-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
105 otherwise healthy individuals, who have cardiovascular risk factors and mild to moderate stress or anxiety will be randomly assigned to one of the three intervention groups: an 8 week program of Mindfulness, 12 week program of Yoga practice, and 12 week exercise and education-based group program. All subjects will perform daily practice that will continue after the weekly sessions end, allowing a follow up assessment at 24 weeks. Self-reported mood and psychological distress and physiological indicators of function of the ANS and stress hormones will be assessed at baseline, 8 weeks, 12 weeks and 24 weeks. Blood and urine samples will be collected at baseline and 8 weeks to determine levels inflammatory and atherosclerosis markers.
We anticipate that the study will provide information on the efficacy of the Mindfulness and Yoga interventions as stress-reduction practices, variability in potential markers for activation of the brain/cardiovascular system connections, and preliminary estimates of effect size for each of these markers. Thus, the study will provide the data needed for designing a future study that will rigorously address these questions in a larger, randomized trial of Mindfulness and Yoga in patients with cardiovascular risk.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mindfulness Meditation
Mindfulness Meditation
The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.
Yoga
Yoga
The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.
Conventional Stress Reduction
Exercise, Relaxation, and Health Education
The Exercise, Relaxation and Health Education program will consist of a 90 min group session that will include simple relaxation (such as progressive muscle relaxation) and light stretching exercises, group support, and discussions of various health topics and on stress reduction.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mindfulness Meditation
The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.
Yoga
The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.
Exercise, Relaxation, and Health Education
The Exercise, Relaxation and Health Education program will consist of a 90 min group session that will include simple relaxation (such as progressive muscle relaxation) and light stretching exercises, group support, and discussions of various health topics and on stress reduction.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A Framingham score \>10
* A DASS-21 anxiety score \>5
* A DASS-21 stress score \>10
* A DASS-21 depression score \> than 6
* A systolic blood pressure \> 140
* A diastolic blood pressure \> 90
* Diagnosed with diabetes
* Willing to accept randomization into and participation in one of the three intervention programs: Mindfulness, Yoga, or Conventional Stress Reduction
Exclusion Criteria
* Already enrolled in a lifestyle modification program including exercise or diet program
* Yoga or meditation be incompatible with religious or philosophical beliefs
* Experienced a major stressful life event in the last three months prior to the beginning of the intervention that is likely to affect the outcomes of the study
* Currently being treated or on medications for psychiatric conditions, including depression, anxiety, anger, or hostility
* A depression score \>20 on the DASS-21 questionnaire
* A history of myocardial disease, peripheral vascular disease, cerebrovascular disease, atrial fibrillation, pacemaker placement, heart failure, valvular heart disease, congenital heart disease, Wolf-Parkinson White Syndrome, cardiomyopathy, or severe left ventricular systolic dysfunction
* Take melatonin supplements or any herbal supplement that contains melatonin or 5-LO inhibitors (turmeric, curcumin, ginger and frankincense herbal extracts)
* Currently using any drugs that contain beta-adrenergic blocking agents, beta-agonists, glucocorticoids, psychotropic medications, drugs that block 5-LO pathway (zileuton, monetlukast), TNF-a blocking agents (infliximab, etanercept, adalimumab)
* A planned change in blood pressure, anticoagulant medication and lipids lower agents (such as aspirin, statin and plavix) 1 month prior and during the intervention
* Asthma, obstructive pulmonary disease, or any other respiratory disease
* Pregnant or breastfeeding
* An active/chronic infection, cancer, connective tissue, or other inflammatory disease
40 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Cleveland Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Joan Fox
Staff
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joan EB Fox, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Cleveland Clinic
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BHBI-1201
Identifier Type: -
Identifier Source: org_study_id