MEG Study of Mindfulness Based Stress Reduction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Somatosensory cortical dynamics
Study Overview
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
Detailed Description
In this study, investigators will randomly assign volunteers to one of two conditions: (1) attend classes to learn MBSR (2) be on a waitlist on which volunteers will continue your activities until the conclusion of the study, at which point they will be offered free MBSR training. The MBSR class and the body scan classes will be videotape-recorded in order to ensure that the instruction meets study standards. Since the videotape will capture your image and voice, you will be identifiable. However, this videotape will only be viewed by HIPAA certified study staff; it will be stored in a locked drawer and will be destroyed 36 months after the completion of the study.
Random assignment works like the flip of a coin. A volunteer has a 1 in 3 chance of receiving MBSR, being asked to continue with his or her normal life, or being asked to practice body scanning. At any time and for any reason at all a volunteer may decide to withdraw from the study. Data about volunteers' experiences, brain structure, and function collected from this study will be stored by investigators at the Osher Institute, Harvard Medical School.
If a volunteer is randomly assigned to receive MBSR, he or she will be asked to attend 8 class sessions of training which will last 2 hours each. He or she will also be asked to attend a 5 hour retreat. In MBSR classes, you will receive instruction in mindfulness based body scan meditation. In addition, a subject assigned to MBSR will receive instruction in sitting meditation and in gentle yoga. Participants in both classes will also be asked to reflect on their meditation experiences during class and will be asked to consider carrying out a home practice during the week, outside of class. MBSR and body scan classes will meet at a meditation class facility convenient to a red line T stop in Cambridge.
Study assessment visits to the Martinos Center facility in Charlestown
In this study, there are 3 study assessment visits to the Martinos Center facility in Charlestown in which volunteers will be asked questions about their daily experience. At all 3 study visits, investigators will also record magnetic field readings of the brain using a non-invasive imaging technique known as magnetoencephalography (MEG). MEG is a technique that measures the small electrical currents produced when cells in the brain are active. This activity is sometimes called "brain waves."
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
1
MBSR 8 week course
Intervention: Mindfulness Based Stress Reduction (Behavioral)
2
8 weeks of natural history
Outcomes
Primary Outcomes
Somatosensory cortical dynamics
Time Frame: 8 weeks
Secondary Outcomes
- Rumination; mindfulness; somatosensory evoked potentials; tactile thresholds(8 weeks)
Investigators
Kerr, Catherine
Associate Professor
Harvard Medical School (HMS and HSDM)