StressNCT01488422
Neural Correlates of Stress Reduction
A study testing Stress Reduction in people with Stress and Psychological Stress, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will identify neural mechanisms associated with changes in emotion regulation following participation in stress reduction programs. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological Stress, Life Stress
- What is being tested?
- Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2014
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 years of age
- Right-handed
- Stressed
Who cannot join
- Lifetime history of schizophrenia or psychosis
- Psychiatric illness
- History of seizure or significant head trauma
- Use of psychotropic medications
- Metallic implants or devices contraindicating magnetic resonance imaging
- Claustrophobia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: Structural and Functional Mechanisms of Stress Reduction
This study will identify neural mechanisms associated with changes in emotion regulation following participation in stress reduction programs.
- Conditions
- Stress, Psychological Stress, Life Stress, Emotional Stress, Social Stress
- Being tested
- Stress Reduction
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ReductionBehavioural
We are comparing 2 well-studied approaches to stress reduction. All participants will receive stress reduction instructions that have already been proven to effectively reduce stress. Our goal is to compare the neural mechanisms associated with both approaches.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Both groups will receive stress reduction materials. We expect both groups to achieve similar amounts of stress reduction, but to use different brain regions to do so. Receives: Behavioral: Stress Reduction |
| Group 2 | Active comparator | Both groups will receive stress reduction materials. We expect both groups to achieve similar amounts of stress reduction, but to use different brain regions to do so. Receives: Behavioral: Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gray matter structure
Study participants will undergo an MRI scan before and after attending an 8-week stress reduction program.
Measured: 8 weeks
Secondary outcomes (1)
Emotion regulation
Study participants will do an emotion regulation task while they are in the MRI scanner. We will assess brain activity and skin conductance during the task. Changes in these measures will be assessed before and after enrollment in the stress reduction program
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 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
- Sara Lazar, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488422
- Sponsor's protocol ID
- AT006344
- Status last verified
- Jan 2015
- First submitted
- 5 Dec 2011
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Joss D. Neural correlates of meditation-induced changes in self-related traits: a resting state fMRI study. Mindfulness (N Y). 2026 Jun 4:10.1007/s12671-026-02885-9. doi: 10.1007/s12671-026-02885-9. Online ahead of print.
PubMed 42306255Sevinc G, Holzel BK, Greenberg J, Gard T, Brunsch V, Hashmi JA, Vangel M, Orr SP, Milad MR, Lazar SW. Strengthened Hippocampal Circuits Underlie Enhanced Retrieval of Extinguished Fear Memories Following Mindfulness Training. Biol Psychiatry. 2019 Nov 1;86(9):693-702. doi: 10.1016/j.biopsych.2019.05.017. Epub 2019 May 30.
PubMed 31303261
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Mechanisms of Stress Reduction
- ClinicalTrials.gov ID
- NCT01488422
- Acronym / sponsor ID
- AT006344
- Conditions
- Stress, Psychological Stress, Life Stress, Emotional Stress, Social Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Dec 2011 (estimated)
- 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.
This study will identify neural mechanisms associated with changes in emotion regulation following participation in stress reduction programs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Behavioral: Stress ReductionBoth groups will receive stress reduction materials. We expect both groups to achieve similar amounts of stress reduction, but to use different brain regions to do so. |
| Group 2 | Active comparator | Behavioral: Stress ReductionBoth groups will receive stress reduction materials. We expect both groups to achieve similar amounts of stress reduction, but to use different brain regions to do so. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-50 years of age
- Right-handed
- Stressed
Key exclusion criteria (7 listed)
- Lifetime history of schizophrenia or psychosis
- Psychiatric illness
- History of seizure or significant head trauma
- Use of psychotropic medications
- Metallic implants or devices contraindicating magnetic resonance imaging
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 |
|---|---|---|
| Stress ReductionWe are comparing 2 well-studied approaches to stress reduction. All participants will receive stress reduction instructions that have already been proven to effectively reduce stress. Our goal is to compare the neural mechanisms associated with both approaches. | Behavioural | Group 1, Group 2 |
Primary outcome
Changes in gray matter structure
Time frame: 8 weeks
Study participants will undergo an MRI scan before and after attending an 8-week stress reduction program.
1 secondary outcome
Emotion regulation
Time frame: 8-weeks
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 15 Jan 2015.
- Derived from this study: PubMed 42306255Joss D. Neural correlates of meditation-induced changes in self-related traits: a resting state fMRI study. Mindfulness (N Y). 2026 Jun 4:10.1007/s12671-026-02885-9. doi: 10.1007/s12671-026-02885-9. Online ahead of print.
- Derived from this study: PubMed 31303261Sevinc G, Holzel BK, Greenberg J, Gard T, Brunsch V, Hashmi JA, Vangel M, Orr SP, Milad MR, Lazar SW. Strengthened Hippocampal Circuits Underlie Enhanced Retrieval of Extinguished Fear Memories Following Mindfulness Training. Biol Psychiatry. 2019 Nov 1;86(9):693-702. doi: 10.1016/j.biopsych.2019.05.017. Epub 2019 May 30.
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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.
Sara Lazar, 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 Stress Reduction in people with Stress and Psychological Stress, 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 3 inclusion and 7 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 15 Jan 2015. 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?
Changes in gray matter structure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01488422, which also lists 2 linked publications.
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 15 Jan 2015.