Wellbeing Stress Reduction and Social Cognition

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Massachusetts General Hospital
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Updated on 19 February 2024
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Summary

There are many ways to improve wellbeing. This study will compare two 8-week wellbeing training programs. In addition to looking at how well the programs reduce stress and enhance wellbeing, the investigators will also ask questions about how these programs influence cognition and decision making.

Description

The training programs that aim to reduce stress and enhance wellbeing differ in terms of the techniques they utilize, as well as in terms of their mechanisms of change. These different mechanisms may have different impact on cognition and decision making. The aim of the study is to compare the different programs and also explore potential mediators of changes in wellbeing.

Details
Condition Cognitive Function 1, Social
Age 18-65 years
Treatment Active Comparator: Program 1, Active Comparator: Program 2
Clinical Study IdentifierNCT04494737
SponsorMassachusetts General Hospital
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

18-65 years of age
Right-handed
Able to speak, understand, and read English
Willing to participate in a 20-week study period and undergo 2 MRI scans at Massachusetts General Hospital (MGH)
Able to safely undergo an MRI scan
Stable medication/treatment regimen (changes in medication must have occurred three months prior to enrollment in this study)
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
Subjects with a history of cerebrovascular problems but have no persistent neurological deficits will be included
Available for scheduled class times for both study courses
Will be staying in the study area for the next 3 months
Able to complete up to 40 minutes of homework per day during the 8-week course

Exclusion Criteria

Cardiovascular disease, stroke, or congestive heart failure
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
Has permanent bridgework in upper mouth that could interfere with MRI scan
Active hematological, renal, pulmonary, endocrine or hepatic disorders
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)
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)
Diagnosis of schizophrenia, post traumatic stress disorder (PTSD), bipolar disorder, or psychotic disorder at any point during lifetime
Diagnosis of any axis I psychiatric disorder within the last 12 months
Weighs more than 350 pounds
Neurological or medical conditions that would interfere with study procedures or confound results, such as conditions that alter cerebral blood flow or metabolism
Unstable medications or on medications with CNS effects including cholinesterase inhibitors, memantine and antidepressants
Use of psychotropic medications within 12 months prior to study
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.)
Any other medications as reviewed by a clinician on a case-by-case basis
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
Has claustrophobia
Any other criteria that will interfere with the subject's participation as determined by a study doctor
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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