This trial is active, not recruiting.

Conditions well-being, depression, anxiety
Treatments control group relaxation techniques, loving-kindness meditation, body scan, sitting practice
Sponsor Grupo de Investigación en salud mental en Atención Primaria
Start date September 2014
End date September 2015
Trial size 80 participants
Trial identifier NCT02191553, PI13/0129


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
(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.
control group relaxation techniques
Jacobson's progressive muscular relaxation, emotional imagining and Schultz's autogenic training.
Loving-kindness meditation following Kristin Neff protocol
loving-kindness meditation
Following Kristin Neff protocol
Body scan as described in standard MBSR 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 as mindfulness meditation described in standard MBSR protocols.
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 Outcomes

Different facets of Mindfulness
time frame: 3 months

Secondary Outcomes

Brain function
time frame: 3 months
Positive and negative affectivity
time frame: 3 months
anxiety and depression
time frame: 3 months
time frame: 3 months
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Differential Effect of Four Mindfulness Exercises on Mindfulness, Cerebral Cartography and Heart Ratio Variability
Principal investigator Javier García Campayo, Dr
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Grupo de Investigación en salud mental en Atención Primaria.