Cognitive Function 1, SocialNCT04494737
Wellbeing, Stress Reduction and Social Cognition
A study testing Active Comparator: Program 1 and Active Comparator: Program 2 in people with Cognitive Function 1, Social, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function 1, Social
- What is being tested?
- Active Comparator: Program 1 and Active Comparator: Program 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Function 1, Social
- Being tested
- Active Comparator: Program 1, Active Comparator: Program 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Program 1Behavioural
A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.
Active Comparator: Program 2Behavioural
A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Program 1 | Active comparator | 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. Receives: Behavioral: Active Comparator: Program 1 |
| Active Comparator: Program 2 | Active comparator | 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. Receives: Behavioral: Active Comparator: Program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural functioning during moral decision-making
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.
Measured: baseline, week 8
Secondary outcomes (1)
Moral Reasoning Ability
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.
Measured: baseline, week 8, week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start5 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function 1, SocialStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara W Lazar, Massachusetts General Hospital
- Investigators
- Gunes Sevinc, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494737
- Sponsor's protocol ID
- 2020A001098
- Status last verified
- Aug 2022
- First submitted
- 14 Feb 2020
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neuroscientific Account of Embodied Ethics: Mindfulness Training Related Improvements In Moral Reasoning
- ClinicalTrials.gov ID
- NCT04494737
- Acronym / sponsor ID
- 2020A001098
- Conditions
- Cognitive Function 1, Social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Program 1 | Active comparator | Behavioral: Active Comparator: Program 1Mindfulness 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 2 | Active comparator | Behavioral: Active Comparator: Program 2Stress 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: Program 1A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization. | Behavioural | Active Comparator: Program 1 |
| Active Comparator: Program 2A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization. | Behavioural | Active Comparator: Program 2 |
Primary outcome
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.
1 secondary outcome
Moral Reasoning Ability
Time frame: baseline, week 8, week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunes Sevinc, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Program 1 and Active Comparator: Program 2 in people with Cognitive Function 1, Social, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural functioning during moral decision-making (time frame: baseline, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.