HealthySesshinNCT00878735
The Effects of a Meditation Retreat on Healthy Volunteers and Cancer Patients: an fMRI Study
A study testing Zen meditation in people with Healthy and Cancer, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Zen meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Israelita de Ensino e Pesquisa Albert Einstein
São Paulo, São Paulo, 05652901
About this study
Official title: 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).
Read the 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.
- Being tested
- Zen meditation
- Keywords
- Meditation, Mindfulness, fMRI, cancer, stress, anxiety, depression, attention, Neuroscience, Neuroimaging, Psychobiology, Healthy volunteers (regular meditators and non-meditators)
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zen meditationBehavioural
Also called Control group: no intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Zen meditation Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Principal investigator, Elisa Kozasa, Hospital Israelita Albert Einstein
- Investigators
- Elisa H Kozasa, PhD, Principal investigator, Instituto Israelita de Ensino e Pesquisa Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878735
- Sponsor's protocol ID
- Sesshin
- Other IDs
- Elisa
- Acronym
- Sesshin
- Status last verified
- Jun 2014
- First submitted
- 8 Apr 2009
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18588603Kozasa 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.
PubMed 21763432
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Intensive Mindfulness Practice (Sesshin) on Neural Systems: an fMRI Evaluation of Healthy Volunteers and Cancer Patients
- ClinicalTrials.gov ID
- NCT00878735
- Acronym / sponsor ID
- Sesshin / Sesshin
- Keywords
- Meditation, Mindfulness, fMRI, cancer, stress, anxiety, depression, attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Zen meditationZen 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zen meditationAlso: Control group: no interventionZen 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. | Behavioural | 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Background: PubMed 18588603Kozasa 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.
- Results publication: PubMed 21763432Kozasa 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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa H Kozasa, PhD principal investigator
Instituto Israelita de Ensino e Pesquisa Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zen meditation in people with Healthy and Cancer, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878735, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2014.