Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT00878735
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2009-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of a Meditation Retreat on Healthy Volunteers and Cancer Patients: an fMRI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-01-06', 'releaseDate': '2019-12-18'}, {'resetDate': '2020-09-11', 'releaseDate': '2020-08-24'}, {'resetDate': '2020-12-03', 'releaseDate': '2020-11-10'}, {'resetDate': '2022-03-08', 'releaseDate': '2022-01-09'}, {'resetDate': '2023-01-06', 'releaseDate': '2022-04-10'}], 'estimatedResultsFirstSubmitDate': '2019-12-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-06', 'studyFirstSubmitDate': '2009-04-08', 'studyFirstSubmitQcDate': '2009-04-08', 'lastUpdatePostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Anxiety, stress and depression symptoms, self-compassion feelings and mindfulness state will also be evaluated in healthy volunteers and cancer patients.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Meditation', 'Mindfulness', 'fMRI', 'cancer', 'stress', 'anxiety', 'depression', 'attention', 'Neuroscience', 'Neuroimaging', 'Psychobiology', 'Healthy volunteers (regular meditators and non-meditators)'], 'conditions': ['Healthy', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '18588603', 'type': 'BACKGROUND', 'citation': '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': '21763432', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy volunteers:\n\n* Men or women\n* Left-handed or right-handed, as long as there are left-handed individuals in both groups for comparison\n* Ages between 18 and 65\n* No history of neurological or psychiatric problems, or use of controlled medication that might interfere with attention\n* No symptoms of claustrophobia\n* Written informed consent form to participate in the study\n\nCancer patients:\n\n* The same criteria that apply to healthy volunteers in addition to a diagnosis of neoplasia confirmed by biopsy\n* 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\n\nExclusion Criteria:\n\nHealthy Volunteers:\n\n* Chemical dependence, including nicotine and alcohol\n* Dementia or psychotic condition (established by a questionnaire)\n* Depression or use of antidepressants\n* 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\n* Neoplasias in the central nervous system\n* 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)\n* Fulfillment of any criterion of contraindication for the MR exam (for instance, use of pacemaker; intracranial aneurism clip; cochlear implants)\n* Presence of odontological devices that might disturb the magnetic field or any sources of variation of the magnetic susceptibility\n* 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.\n* Any other conditions the investigator might deem problematic for the inclusion of the volunteer in a trial of this nature will also be considered\n\nCancer patients:\n\n* 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"\n* The use of medication that acts on the central nervous system'}, 'identificationModule': {'nctId': 'NCT00878735', 'acronym': 'Sesshin', 'briefTitle': 'The Effects of a Meditation Retreat on Healthy Volunteers and Cancer Patients: an fMRI Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Israelita Albert Einstein'}, 'officialTitle': 'The Effects of an Intensive Mindfulness Practice (Sesshin) on Neural Systems: an fMRI Evaluation of Healthy Volunteers and Cancer Patients', 'orgStudyIdInfo': {'id': 'Sesshin'}, 'secondaryIdInfos': [{'id': 'Elisa'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Zen meditation', 'interventionNames': ['Behavioral: Zen meditation']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': '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': [{'name': 'Zen meditation', 'type': 'BEHAVIORAL', 'otherNames': ['Control group: no intervention'], 'description': '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.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05652901', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Israelita de Ensino e Pesquisa Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Elisa H Kozasa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Israelita de Ensino e Pesquisa Albert Einstein'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal University of São Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Elisa Kozasa', 'investigatorAffiliation': 'Hospital Israelita Albert Einstein'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-12-18', 'type': 'RELEASE'}, {'date': '2020-01-06', 'type': 'RESET'}, {'date': '2020-08-24', 'type': 'RELEASE'}, {'date': '2020-09-11', 'type': 'RESET'}, {'date': '2020-11-10', 'type': 'RELEASE'}, {'date': '2020-12-03', 'type': 'RESET'}, {'date': '2022-01-09', 'type': 'RELEASE'}, {'date': '2022-03-08', 'type': 'RESET'}, {'date': '2022-04-10', 'type': 'RELEASE'}, {'date': '2023-01-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Elisa Kozasa, PhD, Hospital Israelita Albert Einstein'}}}}