- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02191553
Differential Effect of Four Mindfulness Exercises
Differential Effect of Four Mindfulness Exercises on Mindfulness, Cerebral Cartography and Heart Ratio Variability
Study Overview
Status
Conditions
Detailed Description
Mindfulness is a way of using attention intentionally, repeatedly reactivating the attentional focus, so that it enhances the ability of sustained attention. It involves a complex process of self-regulation and inhibition of internal and external stimuli interferences.
Although the overall effects of meditation on brain bioelectrical signals are still being characterized, there is some consensus on the fact that meditation helps alter brain activity in both state and trait.
The specific aim of this study is to assess the differential effect of four different practices of mindfulness in psychological well-being and their corresponding neurophysiological correlates.
The hypothesis is that different exercises within the range of mindfulness practices exert different effects in terms of electroencephalographic activity, expecting different band increases in alpha (activity 7-to 2 Hz), beta (activity more than 13 Hz), theta (activity 4-6 Hz) and delta (activity less than 3 Hz) respectively, as well as changes in the lateralization of the activity (left or right hemisphere). We also expect an improvement in the variables such as mindfulness, self-compassion, positive affect, anxiety, depression and sleep quality.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Zaragoza, Spain, 50009
- Arrabal Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- sign of informed consent
- no previous meditation training experience
Exclusion Criteria:
- mental or neurologic disorder
- respiratory disease
- previous brain damage history
- medication intake that could interfere in the electroencephalographic results
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Control Group: Relaxation Techniques
Relaxation techniques which do not involve either formal or informal mindfulness training.
Subjects in this group practice Jacobson's progressive muscular relaxation, emotional imagining and Schultz's autogenic training.
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Jacobson's progressive muscular relaxation, emotional imagining and Schultz's autogenic training.
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Experimental: Loving Kindness Meditation (Metta)
Loving-kindness meditation following Kristin Neff protocol
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Following Kristin Neff protocol
|
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Experimental: Body Scan
Body scan as described in standard MBSR protocol
|
Body scan: Attention being directed with detailed awareness to every part of the body for a sustained period of time.
|
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Experimental: Sitting Practice
Sitting practice as mindfulness meditation described in standard MBSR protocols.
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In the sitting exercise, participants are guided to pay attention to a certain range of still points, starting with attention to breathing.
In this exercise attention is fully concentrated on a single object: the sensation attached to breathing.
If the mind wanders or is distracted by an external stimulus, attention is gently returned to sensations derived from breathing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Different facets of Mindfulness
Time Frame: 3 months
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The Five Facets Mindfulness Questionnaire (FFMQ) will be used: It assesses the following facets of mindfulness: Observing, describing, acting with awareness, non judging of inner experience and non-reactivity to inner experience
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Brain function
Time Frame: 3 months
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We will use cerebral cartography
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3 months
|
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Positive and negative affectivity
Time Frame: 3 months
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It will be measured with PANAS questionnaire
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3 months
|
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anxiety and depression
Time Frame: 3 months
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Measured with Hospital Anxiety Depression Scale
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3 months
|
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Insomnia
Time Frame: 3 months
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Measured with Pittsburgh Sleep Quality Index (PSQI)
|
3 months
|
|
Self-compassion
Time Frame: 3 months
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Measured with Self-Compassion Scale
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3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
heart function and heart variability rate
Time Frame: 3 months
|
The investigators will use electrocardiogram
|
3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Javier García Campayo, Dr, Aragon Health Sciences Institute (IACS)
Publications and helpful links
General Publications
- Soler J, Cebolla A, Feliu-Soler A, Demarzo MM, Pascual JC, Banos R, Garcia-Campayo J. Relationship between meditative practice and self-reported mindfulness: the MINDSENS composite index. PLoS One. 2014 Jan 22;9(1):e86622. doi: 10.1371/journal.pone.0086622. eCollection 2014.
- Fayed N, Lopez Del Hoyo Y, Andres E, Serrano-Blanco A, Bellon J, Aguilar K, Cebolla A, Garcia-Campayo J. Brain changes in long-term zen meditators using proton magnetic resonance spectroscopy and diffusion tensor imaging: a controlled study. PLoS One. 2013;8(3):e58476. doi: 10.1371/journal.pone.0058476. Epub 2013 Mar 25.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI13/0129
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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