The Effects of a Meditation Retreat on Healthy Volunteers and Cancer Patients: an fMRI Study (Sesshin)
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878735
|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|