Differential Effect of Four Mindfulness Exercises

NCT ID: NCT02191553

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-04-30

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.

Conditions

Well-being; Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Control group relaxation techniques

Intervention Type: BEHAVIORAL

Jacobson's progressive muscular relaxation, emotional imagining and Schultz's autogenic training.

Loving Kindness Meditation (Metta)

Loving-kindness meditation following Kristin Neff protocol

Group Type: EXPERIMENTAL

Loving-kindness meditation

Intervention Type: BEHAVIORAL

Following Kristin Neff protocol

Body Scan

Body scan as described in standard MBSR protocol

Group Type: EXPERIMENTAL

Body scan

Intervention Type: BEHAVIORAL

Body scan: Attention being directed with detailed awareness to every part of the body for a sustained period of time.

Sitting Practice

Sitting practice as mindfulness meditation described in standard MBSR protocols.

Group Type: EXPERIMENTAL

Sitting practice

Intervention Type: BEHAVIORAL

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.

Interventions

Control group relaxation techniques

Jacobson's progressive muscular relaxation, emotional imagining and Schultz's autogenic training.

Intervention Type: BEHAVIORAL

Loving-kindness meditation

Following Kristin Neff protocol

Intervention Type: BEHAVIORAL

Body scan

Body scan: Attention being directed with detailed awareness to every part of the body for a sustained period of time.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Miguel Servet

OTHER

Sponsor Role: lead

Responsible Party

Javier Garcia Campayo

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Javier García Campayo, Dr

Role: PRINCIPAL_INVESTIGATOR

Aragon Health Sciences Institute (IACS)

Locations

Arrabal Health Center

Zaragoza, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 23536796 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24466175 (View on PubMed)

Other Identifiers

PI13/0129

Identifier Type: -

Identifier Source: org_study_id