NCT00571051

Brief Summary

The purpose of this research is to investigate the effects of mindfulness based stress reduction (MBSR) on measures of brain function. We are looking especially at the ways in which MBSR may affect the way the brain processes the sense of touch. The study seeks to recruit healthy, normal adults who are interested in MBSR training, a simple program that involves learning how to pay attention mindfully to the present moment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 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

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

September 11, 2019

Status Verified

August 1, 2009

Enrollment Period

3.5 years

First QC Date

December 7, 2007

Last Update Submit

September 10, 2019

Conditions

Keywords

MEG, mindfulness, tactile perception

Outcome Measures

Primary Outcomes (1)

  • Somatosensory cortical dynamics

    8 weeks

Secondary Outcomes (1)

  • Rumination; mindfulness; somatosensory evoked potentials; tactile thresholds

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

MBSR 8 week course

Behavioral: Mindfulness Based Stress Reduction

2

NO INTERVENTION

8 weeks of natural history

Interventions

8 week course in mindfulness training

Also known as: Course is modelled on course taught by Center for Mindfulness, UMASS Worcester. Instructor and lesson plan are certified by Center for Mindfulness
1

Eligibility Criteria

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

You may qualify if:

  • You are eligible to participate in this study because you meet all of our selection criteria:
  • You are between ages 18-50
  • You are right-handed
  • You are able to receive a MRI scan (you have no metal implants or other metal objects or medical devices that would make a MRI scan unsafe for you)
  • You are able to follow study instructions and can read and write English

You may not qualify if:

  • You are not eligible to participate in this study if you:
  • have any systemic musculoskeletal diseases such as rheumatoid arthritis, systemic lupus, or scleroderma that would affect the function of your nervous system
  • have any neurological conditions that might affect your hand, wrist, or arm function
  • respond to our questionnaires in a manner suggesting you may be suffering from depression
  • are pregnant or a nursing mother
  • currently have any ongoing meditation practice, including MBSR.
  • are unable to complete our study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard Medical School

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Kerr CE, Wasserman RH, Moore CI. Cortical dynamics as a therapeutic mechanism for touch healing. J Altern Complement Med. 2007 Jan-Feb;13(1):59-66. doi: 10.1089/acm.2006.5245.

    PMID: 17309379BACKGROUND

MeSH Terms

Interventions

Mindfulness-Based Stress ReductionMindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Catherine Kerr, PhD

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 11, 2007

Study Start

October 1, 2007

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

September 11, 2019

Record last verified: 2009-08

Locations