The Effects of a Meditation Retreat on Healthy Volunteers and Cancer Patients: an fMRI Study (Sesshin)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00878735 |
Recruitment Status :
Completed
First Posted : April 9, 2009
Last Update Posted : June 9, 2014
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Cancer | Behavioral: Zen meditation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 96 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | January 2009 |
Arm | Intervention/treatment |
---|---|
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)
|
- 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 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878735
Brazil | |
Instituto Israelita de Ensino e Pesquisa Albert Einstein | |
São Paulo, Brazil, 05652901 |
Principal Investigator: | Elisa H Kozasa, PhD | Instituto Israelita de Ensino e Pesquisa Albert Einstein |
Other Publications:
Responsible Party: | Elisa Kozasa, PhD, Hospital Israelita Albert Einstein |
ClinicalTrials.gov Identifier: | NCT00878735 |
Other Study ID Numbers: |
Sesshin Elisa |
First Posted: | April 9, 2009 Key Record Dates |
Last Update Posted: | June 9, 2014 |
Last Verified: | June 2014 |
Meditation Mindfulness fMRI cancer stress anxiety |
depression attention Neuroscience Neuroimaging Psychobiology Healthy volunteers (regular meditators and non-meditators) |