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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
- 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
- Brain function [ Time Frame: 3 months ]We will use cerebral cartography
- Positive and negative affectivity [ Time Frame: 3 months ]It will be measured with PANAS questionnaire
- anxiety and depression [ Time Frame: 3 months ]Measured with Hospital Anxiety Depression Scale
- Insomnia [ Time Frame: 3 months ]Measured with Pittsburgh Sleep Quality Index (PSQI)
- Self-compassion [ Time Frame: 3 months ]Measured with Self-Compassion Scale
- heart function and heart variability rate [ Time Frame: 3 months ]The investigators will use electrocardiogram
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
|Arrabal Health Center|
|Zaragoza, Spain, 50009|
|Principal Investigator:||Javier García Campayo, Dr||Aragon Health Sciences Institute (IACS)|