NCT01488422

Brief Summary

This study will identify neural mechanisms associated with changes in emotion regulation following participation in stress reduction programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

3 years

First QC Date

December 5, 2011

Last Update Submit

January 14, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in gray matter structure

    Study participants will undergo an MRI scan before and after attending an 8-week stress reduction program.

    8 weeks

Secondary Outcomes (1)

  • Emotion regulation

    8-weeks

Study Arms (2)

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.

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.

Behavioral: Stress Reduction

Interventions

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.

Group 1Group 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Right-handed
  • Stressed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Sevinc 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.

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sara Lazar, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Scientist

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 8, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations