The Effects of an Intensive Mindfulness Practice (Sesshin) on Neural Systems: an fMRI Evaluation of Healthy Volunteers and Cancer Patients
18 Years
65 Years
Both
Healthy, Cancer
Trial Information
The Effects of an Intensive Mindfulness Practice (Sesshin) on Neural Systems: an fMRI Evaluation of Healthy Volunteers and Cancer Patients
Meditation results in changes in cognition, sensory perception, affect, hormones, and
autonomic activity. Until today, there have been very few imaging studies of the neural
correlates of meditation. Instead of evaluating the meditation practice itself, our approach
is to evaluate the neural correlates of performance modulation on an attention paradigm (the
Stroop word-color task; SWCT) and an emotional paradigm (the frustration paradigm) before
and after a meditation retreat. The following categories of individuals will be invited to
participate: healthy regular meditation practitioners (at least three years of practice,
three times a week), individuals inexperienced in meditation, and patients with a cancer
diagnosis. The total sample will comprise 96 individuals who will be allocated to groups of
sesshin meditation, rest groups and groups that will keep their daily activities. If they
wish to do so, those who participate in the two latter groups may also receive training on
meditation. The subjects will be between 18 and 65 years old and have no contraindication to
the fMRI exam. After signing an informed consent form, the subjects will answer anxiety,
depression and stress inventories; scales that evaluate their feelings of self-compassion
and mindfulness, as well as the Stroop Color Word task and an emotional paradigm of
functional Magnetic Resonance Imaging.
Inclusion Criteria:
Healthy volunteers:
- Men or women
- Left-handed or right-handed, as long as there are left-handed individuals in both
groups for comparison
- Ages between 18 and 65
- No history of neurological or psychiatric problems, or use of controlled medication
that might interfere with attention
- No symptoms of claustrophobia
- Written informed consent form to participate in the study
Cancer patients:
- The same criteria that apply to healthy volunteers in addition to a diagnosis of
neoplasia confirmed by biopsy
- Volunteers should be undergoing post-therapeutical control, have no cure criteria
yet, and not have been submitted to radio- or chemotherapy in the last three months
Exclusion Criteria:
Healthy Volunteers:
- Chemical dependence, including nicotine and alcohol
- Dementia or psychotic condition (established by a questionnaire)
- Depression or use of antidepressants
- Non-controlled severe organic disease that might interfere with the performance of
the study, such as neoplasias, cardiopathies, digestive pathologies, diabetes
mellitus type I or type II
- Neoplasias in the central nervous system
- Tremor or dystonia in cephalic segment that hinders the performance of the RMf study
(tremor equal to or higher than 3 in each corporal segment, according to the UPDRS
scale)
- Fulfillment of any criterion of contraindication for the MR exam (for instance, use
of pacemaker; intracranial aneurism clip; cochlear implants)
- Presence of odontological devices that might disturb the magnetic field or any
sources of variation of the magnetic susceptibility
- Presence of lesion in the encephalic parenchyma in the structural images. Exception
is made to discreet punctiform areas in the white matter or a discreet reduction in
the encephalic volume.
- Any other conditions the investigator might deem problematic for the inclusion of the
volunteer in a trial of this nature will also be considered
Cancer patients:
- All the healthy volunteers, except for those that fit in the item: "non-controlled
severe organic disease that might interfere in the performance of the study, such"
- The use of medication that acts on the central nervous system
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
Outcome Measure:
To evaluate the neural correlates of performance modulation on an attention paradigm (the Stroop word-color task; SWCT) and on an emotional paradigm (the frustration paradigm) before and after a Zen meditation retreat.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Elisa H Kozasa, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Instituto Israelita de Ensino e Pesquisa Albert Einstein
Authority:
Brazil: Ethics Committee
Study ID:
Sesshin
NCT ID:
NCT00878735
Start Date:
January 2008
Completion Date:
Related Keywords:
- Healthy
- Cancer
- Meditation
- Mindfulness
- fMRI
- cancer
- stress
- anxiety
- depression
- attention
- Neuroscience
- Neuroimaging
- Psychobiology
- Healthy volunteers (regular meditators and non-meditators)
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