The Effects of a Meditation Retreat on Healthy Volunteers and Cancer Patients: an fMRI Study (Sesshin)

This study has been completed.
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Elisa Kozasa, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT00878735
First received: April 8, 2009
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the effects of a Zen meditation retreat (Sesshin) on psychophysiological parameters in healthy volunteers (regular meditators and non-meditators) and in cancer patients and to observe possible changes in the attentional circuitry (through functional Magnetic Resonance Imaging- fMRI) and in psychological tests (Beck Anxiety and Depression Inventories, Self-Compassion Scale, Mindfulness Attention Awareness Scale, Lipp Stress Scale for Adults).


Condition Intervention
Healthy
Cancer
Behavioral: Zen meditation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: The Effects of an Intensive Mindfulness Practice (Sesshin) on Neural Systems: an fMRI Evaluation of Healthy Volunteers and Cancer Patients

Resource links provided by NLM:


Further study details as provided by Hospital Israelita Albert Einstein:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety, stress and depression symptoms, self-compassion feelings and mindfulness state will also be evaluated in healthy volunteers and cancer patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: January 2008
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Zen meditation
Behavioral: Zen meditation
Zen meditation retreat (7 days: 5 days from 5:30 to 9:30 plus one day for adaptation and the departure day). The program starts everyday at 5:30 and finish at 9:30. In silence, the volunteers perform seating and walking meditation, stretching exercises, eating and all tasks in mindfulness.
Other Name: Control group: no intervention
No Intervention: 2
No meditation (no intervention; keep regular activities) or a resting group (this group stays at the same place of the retreat group, but only to rest)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878735

Locations
Brazil
Instituto Israelita de Ensino e Pesquisa Albert Einstein
São Paulo, Brazil, 05652901
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Federal University of São Paulo
Investigators
Principal Investigator: Elisa H Kozasa, PhD Instituto Israelita de Ensino e Pesquisa Albert Einstein
  More Information

Publications:
Responsible Party: Elisa Kozasa, PhD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT00878735     History of Changes
Other Study ID Numbers: Sesshin, Elisa
Study First Received: April 8, 2009
Last Updated: June 6, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital Israelita Albert Einstein:
Meditation
Mindfulness
fMRI
cancer
stress
anxiety
depression
attention
Neuroscience
Neuroimaging
Psychobiology
Healthy volunteers (regular meditators and non-meditators)

ClinicalTrials.gov processed this record on September 16, 2014