Clinical trial NCT02191553: Differential Effect of Four Mindfulness Exercises
Official title: Differential Effect of Four Mindfulness Exercises on Mindfulness, Cerebral Cartography and Heart Ratio Variability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-being
Depression
Anxiety
Keywords: mindfulness meditation
alpha rhythm
EEG
brain mapping
emotion
attention
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mindfulness can be considered as a family of complex attentional and emotional regulation strategies that promote the cultivation of well-being and emotional balance. The practice of mindfulness produces the development of a consciousness that unfolds moment to moment, open and unprejudiced in the present moment, here and now. Despite its extensive benefits, the practice of mindfulness requires a significant commitment in time and effort, which limits the potential for its dissemination. The studies to narrow the differential effects of the various exercises based on mindfulness, will further enhance their effectiveness and they can guide the practice sequence according to user needs. In this paper we will research mindfulness electroencephalographic correlates of as four different exercise programs included in mindfulness-based cognitive therapy (MBCT) and stress reduction program based on mindfulness (MBSR) as well as its effect on several psychological variables.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Different facets of Mindfulness
timeFrame: 3 months
Secondary outcomes:
measure: Brain function
timeFrame: 3 months
measure: Positive and negative affectivity
timeFrame: 3 months
measure: anxiety and depression
timeFrame: 3 months
measure: Insomnia
timeFrame: 3 months
measure: Self-compassion
timeFrame: 3 months
Other outcomes:
measure: heart function and heart variability rate
timeFrame: 3 months
Locations:
city: Zaragoza
country: Spain
facility: Arrabal Health Center
Study officials:
affiliation: Aragon Health Sciences Institute (IACS)
name: Javier García Campayo, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.