NCT02191553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

July 9, 2014

Last Update Submit

February 21, 2019

Conditions

Keywords

mindfulness meditationalpha rhythmEEGbrain mappingemotionattention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Brain function

    3 months

  • Positive and negative affectivity

    3 months

  • anxiety and depression

    3 months

  • Insomnia

    3 months

  • Self-compassion

    3 months

Other Outcomes (1)

  • heart function and heart variability rate

    3 months

Study Arms (4)

Control Group: Relaxation Techniques

ACTIVE COMPARATOR

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.

Behavioral: Control group relaxation techniques

Loving Kindness Meditation (Metta)

EXPERIMENTAL

Loving-kindness meditation following Kristin Neff protocol

Behavioral: Loving-kindness meditation

Body Scan

EXPERIMENTAL

Body scan as described in standard MBSR protocol

Behavioral: Body scan

Sitting Practice

EXPERIMENTAL

Sitting practice as mindfulness meditation described in standard MBSR protocols.

Behavioral: Sitting practice

Interventions

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

Control Group: Relaxation Techniques

Following Kristin Neff protocol

Loving Kindness Meditation (Metta)
Body scanBEHAVIORAL

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

Body Scan

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.

Sitting Practice

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sign of informed consent
  • no previous meditation training experience

You may not qualify if:

  • mental or neurologic disorder
  • respiratory disease
  • previous brain damage history
  • medication intake that could interfere in the electroencephalographic results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arrabal Health Center

Zaragoza, 50009, Spain

Location

Related Publications (2)

  • 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.

    PMID: 24466175BACKGROUND
  • 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.

    PMID: 23536796BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Whole Body Imaging

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Javier García Campayo, Dr

    Aragon Health Sciences Institute (IACS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 16, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

April 1, 2017

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations