Differential Effect of Four Mindfulness Exercises

Depression Clinical Trial

Official title:

Differential Effect of Four Mindfulness Exercises on Mindfulness, Cerebral Cartography and Heart Ratio Variability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191553
• Other study ID #: PI13/0129
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: April 2017

Study information

• Verified date: February 2019
• Source: Hospital Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Well-being

Intervention

Behavioral:
• Control group relaxation techniques
Jacobson's progressive muscular relaxation, emotional imagining and Schultz's autogenic training.
• Loving-kindness meditation
Following Kristin Neff protocol
• Body scan
Body scan: Attention being directed with detailed awareness to every part of the body for a sustained period of time.
• Sitting practice
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.

Locations

Country	Name	City	State
Spain	Arrabal Health Center	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Miguel Servet

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Fayed N, Lopez Del Hoyo Y, Andres E, Serrano-Blanco A, Bellón 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. — View Citation

Soler J, Cebolla A, Feliu-Soler A, Demarzo MM, Pascual JC, Baños R, García-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	heart function and heart variability rate	The investigators will use electrocardiogram	3 months
Primary	Different facets of Mindfulness	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	3 months
Secondary	Brain function	We will use cerebral cartography	3 months
Secondary	Positive and negative affectivity	It will be measured with PANAS questionnaire	3 months
Secondary	anxiety and depression	Measured with Hospital Anxiety Depression Scale	3 months
Secondary	Insomnia	Measured with Pittsburgh Sleep Quality Index (PSQI)	3 months
Secondary	Self-compassion	Measured with Self-Compassion Scale	3 months

External Links

•   Description of the research & teaching activities on mindfulness of REDIAPP research network