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Trial record 46 of 111 for:    "Depressive Disorder" [DISEASE] AND Behavioral AND Mental | ( Map: Spain )

Differential Effect of Four Mindfulness Exercises

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ClinicalTrials.gov Identifier: NCT02191553
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Javier Garcia Campayo, Hospital Miguel Servet

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.

Condition or disease Intervention/treatment Phase
Well-being Depression Anxiety Behavioral: Control group relaxation techniques Behavioral: Loving-kindness meditation Behavioral: Body scan Behavioral: Sitting practice Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Differential Effect of Four Mindfulness Exercises on Mindfulness, Cerebral Cartography and Heart Ratio Variability
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Control group relaxation techniques
Jacobson's progressive muscular relaxation, emotional imagining and Schultz's autogenic training.

Experimental: Loving Kindness Meditation (Metta)
Loving-kindness meditation following Kristin Neff protocol
Behavioral: Loving-kindness meditation
Following Kristin Neff protocol

Experimental: Body Scan
Body scan as described in standard MBSR protocol
Behavioral: Body scan
Body scan: Attention being directed with detailed awareness to every part of the body for a sustained period of time.

Experimental: Sitting Practice
Sitting practice as mindfulness meditation described in standard MBSR protocols.
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.




Primary Outcome Measures :
  1. Different facets of Mindfulness [ Time Frame: 3 months ]
    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


Secondary Outcome Measures :
  1. Brain function [ Time Frame: 3 months ]
    We will use cerebral cartography

  2. Positive and negative affectivity [ Time Frame: 3 months ]
    It will be measured with PANAS questionnaire

  3. anxiety and depression [ Time Frame: 3 months ]
    Measured with Hospital Anxiety Depression Scale

  4. Insomnia [ Time Frame: 3 months ]
    Measured with Pittsburgh Sleep Quality Index (PSQI)

  5. Self-compassion [ Time Frame: 3 months ]
    Measured with Self-Compassion Scale


Other Outcome Measures:
  1. heart function and heart variability rate [ Time Frame: 3 months ]
    The investigators will use electrocardiogram



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191553


Locations
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Spain
Arrabal Health Center
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hospital Miguel Servet
Investigators
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Principal Investigator: Javier García Campayo, Dr Aragon Health Sciences Institute (IACS)

Additional Information:
Publications:
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Responsible Party: Javier Garcia Campayo, PhD, Hospital Miguel Servet
ClinicalTrials.gov Identifier: NCT02191553     History of Changes
Other Study ID Numbers: PI13/0129
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Keywords provided by Javier Garcia Campayo, Hospital Miguel Servet:
mindfulness meditation
alpha rhythm
EEG
brain mapping
emotion
attention
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms