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
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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-01-05
2021-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Active Comparator: Program 1
Mindfulness Training program is based on mindfulness based stress reduction developed by Kabat-Zinn, but the didactic content is focused on attention training and meta-awareness. Participants will be taught formal open awareness meditation, gentle yoga, and a 'body scan' meditation during weekly classes. Importantly, there is no retreat day included in the program.
Active Comparator: Program 1
A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.
Active Comparator: Program 2
Stress Management Education (SME) is designed to control for non-specific factors such as contact hours, stress education, and gentle exercise. Stress education classes will consist of teaching about the effects of stress on health and optimizing one's personal health care, understanding positive coping behavior, optimizing nutrition to decrease stress, and exercise and strength training.
Active Comparator: Program 2
A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.
Interventions
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Active Comparator: Program 1
A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.
Active Comparator: Program 2
A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.
Eligibility Criteria
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Inclusion Criteria
2. Right-handed.
3. Able to speak, understand, and read English.
4. Willing to participate in a 20-week study period and undergo 2 MRI scans at Massachusetts General Hospital (MGH).
5. Able to safely undergo an MRI scan.
6. Stable medication/treatment regimen (changes in medication must have occurred three months prior to enrollment in this study).
7. Subjects with well-controlled vascular risk factors, such as treated hypertension, treated hyperlipidemia or well-controlled Type II diabetes (glucose levels \< 250) will be included.
8. Subjects with a history of cerebrovascular problems but have no persistent neurological deficits will be included.
9. Available for scheduled class times for both study courses.
10. Will be staying in the study area for the next 3 months.
11. Able to complete up to 40 minutes of homework per day during the 8-week course.
Exclusion Criteria
2. Has any of, or is; surgical aneurysm clips, neurostimulator, implanted pumps, metal fragments in eyes, pregnant, cardiac pacemaker, non-removable nitroglycerin patch, non-MRI compatible cochlear implants, any other non-MRI compatible metal in body.
3. Has permanent bridgework in upper mouth that could interfere with MRI scan.
4. Active hematological, renal, pulmonary, endocrine or hepatic disorders.
5. A history of neurological disease or injury, including a history of seizures or significant head trauma (i.e., extended loss of consciousness, bleeding in the brain, Parkinson's disease, stroke).
6. Received treatment for cancer within the last year (skin cancer will be allowed as will any cancer more than 2 years since the last treatment).
7. Diagnosis of schizophrenia, post traumatic stress disorder (PTSD), bipolar disorder, or psychotic disorder at any point during lifetime.
8. Diagnosis of any axis I psychiatric disorder within the last 12 months.
9. Weighs more than 350 pounds
10. Neurological or medical conditions that would interfere with study procedures or confound results, such as conditions that alter cerebral blood flow or metabolism.
11. Unstable medications or on medications with CNS effects including cholinesterase inhibitors, memantine and antidepressants.
12. Use of psychotropic medications within 12 months prior to study.
13. Daily use of any medication that alters neural metabolism or blood flow, including chronic use of benzodiazepines, potent central nervous system (CNS) penetrant anticholinergic medications (for bladder control or allergies). These medications taken on an as needed basis (prn) will be allowed. (Over the counter supplements, such as Gingko and fish oil will be allowed.)
14. Any other medications as reviewed by a clinician on a case-by-case basis.
15. Current regular formal practice of meditation, tai chi, Feldenkrais or other mind-body practice with a teacher for more than 2 months within the past year, or more than 1 year of practice within the last 10 years. Significant prior mind-body experience as determined by the PI based on frequency, duration, recency and type of practice.
16. Has claustrophobia.
17. Any other criteria that will interfere with the subject's participation as determined by a study doctor.
18 Years
65 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Sara W Lazar
Associate Researcher in Psychiatry, Assistant Professor in Psychology
Principal Investigators
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Gunes Sevinc, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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MGH
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2020A001098
Identifier Type: -
Identifier Source: org_study_id
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