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

June 6, 2014 updated by: Elisa Kozasa, Hospital Israelita Albert Einstein

The Effects of an Intensive Mindfulness Practice (Sesshin) on Neural Systems: an fMRI Evaluation of Healthy Volunteers and Cancer Patients

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05652901
        • Instituto Israelita de Ensino e Pesquisa Albert Einstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Collaborators

Federal University of São Paulo

Investigators

  • Principal Investigator: Elisa H Kozasa, PhD, Instituto Israelita de Ensino e Pesquisa Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

April 8, 2009

First Submitted That Met QC Criteria

April 8, 2009

First Posted (Estimate)

April 9, 2009

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 6, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sesshin
  • Elisa

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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