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

NCT00878735 | Completed DMC

• 2 other identifiers: SesshinElisa
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy; Cancer

Keywords

Meditation; Mindfulness; fMRI; cancer; stress; anxiety; depression; attention; Neuroscience; Neuroimaging; Psychobiology; Healthy volunteers (regular meditators and non-meditators)

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Anxiety, stress and depression symptoms, self-compassion feelings and mindfulness state will also be evaluated in healthy volunteers and cancer patients.

  2 years

Study Arms (2)

1

EXPERIMENTAL

Zen meditation

Behavioral: Zen meditation

2

NO INTERVENTION

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)

Interventions

Zen meditation BEHAVIORAL

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.

Also known as: Control group: no intervention

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Federal University of São Paulo: collaborator

Study Sites (1)

Instituto Israelita de Ensino e Pesquisa Albert Einstein

São Paulo, São Paulo, 05652901, Brazil

Location

Related Publications (2)

• Kozasa EH, Radvany J, Barreiros MA, Leite JR, Amaro E Jr. Preliminary functional magnetic resonance imaging Stroop task results before and after a Zen meditation retreat. Psychiatry Clin Neurosci. 2008 Jun;62(3):366. doi: 10.1111/j.1440-1819.2008.01809.x. No abstract available.

  PMID: 18588603 BACKGROUND

• Kozasa EH, Sato JR, Lacerda SS, Barreiros MA, Radvany J, Russell TA, Sanches LG, Mello LE, Amaro E Jr. Meditation training increases brain efficiency in an attention task. Neuroimage. 2012 Jan 2;59(1):745-9. doi: 10.1016/j.neuroimage.2011.06.088. Epub 2011 Jul 7.

  PMID: 21763432 RESULT

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Elisa H Kozasa, PhD

  Instituto Israelita de Ensino e Pesquisa Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Last Updated: June 9, 2014

Record last verified: 2014-06

Locations

BR (1)