- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04494737
Wellbeing, Stress Reduction and Social Cognition
August 22, 2022 updated by: Sara W Lazar, Massachusetts General Hospital
A Neuroscientific Account of Embodied Ethics: Mindfulness Training Related Improvements In Moral Reasoning
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02129
- MGH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
A well-established behavioral method for reducing stress.
To maintain blinding, details will be given to participants after randomization.
|
Active Comparator: 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.
|
A well-established behavioral method for reducing stress.
To maintain blinding, details will be given to participants after randomization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neural functioning during moral decision-making
Time Frame: baseline, week 8
|
The name of the measurement is neural functioning during moral decision-making.
To assess neural functioning, participants will undergo a functional MRI scan while they perform a moral judgment task.
The task that involves moral (n=18) and non-moral (n=18) dilemma vignettes.
These dilemmas have been validated and will be presented as text in an event related design.
The participant specific task-related brain activity will be generated by contrasting brain activity between moral and non-moral dilemmas using Statistical Parametric Mapping software.
The unit of measure is BOLD signal and the blood-oxygen level dependent (BOLD) signal contrast of interest is moral vs. nonmoral dilemmas.
|
baseline, week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moral Reasoning Ability
Time Frame: baseline, week 8, week 16
|
Defining Issues Test-2 (DIT-2) is the name of the measurement.
It is a survey, that assesses participants' developmental level of moral reasoning ability.
The resulting scores at the DIT-2 test indicate levels of higher order moral reasoning.
|
baseline, week 8, week 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gunes Sevinc, PhD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2021
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
August 30, 2021
Study Registration Dates
First Submitted
February 14, 2020
First Submitted That Met QC Criteria
July 30, 2020
First Posted (Actual)
July 31, 2020
Study Record Updates
Last Update Posted (Actual)
August 24, 2022
Last Update Submitted That Met QC Criteria
August 22, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2020A001098
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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