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Clinical Trials/NCT05317754
NCT05317754
Active, not recruiting
Not Applicable

Effectiveness of Four Deconstructive Meditative Practices on Well-being and Self-deconstruction: An Exploratory Randomized Controlled Trial

Hospital Miguel Servet1 site in 1 country240 target enrollmentFebruary 11, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Health Wellness
Sponsor
Hospital Miguel Servet
Enrollment
240
Locations
1
Primary Endpoint
The Nondual Embodiment Thematic Inventory (NETI)
Status
Active, not recruiting
Last Updated
7 months ago

Overview

Brief Summary

The efficacy of interventions based on mindfulness and compassion has been demonstrated in both clinical and general population, and in different social contexts. These interventions include so-called attentional and constructive meditation practices, respectively. However, unlike these, there is a third group, known as deconstructive meditation practices, which has not been scientifically studied. Deconstructive practices aim to undo maladaptive cognitive patterns and generate knowledge about internal models of oneself, others and the world. Although there are theoretical and philosophical studies on the origin of addiction to the self or on the mechanisms of action associated with the deconstruction of the self, there are no randomized controlled trials evaluating these techniques in either a healthy population or clinical samples. This study aims to evaluate the effect of three deconstructive techniques by comparing them to the practice of mindfulness in the general population.

A randomized controlled clinical trial (RCT) will be conducted with about 240 participants allocated (1:1:1:1) to four groups: a) mindful breathing, b) prostrations, according to Tibetan Buddhist tradition; c) the Koan Mu, according to Zen Buddhist tradition; and d) the mirror exercise, according to Toltec tradition. The primary outcome will be the qualities of the non-dual experience and spiritual awakening, measured by the Nondual Embodiment Thematic Inventory, assessed at pre and post-treatment and at 3 and 6-month follow ups. Other outcomes will be mindfulness, happiness, compassion, affectivity and altered state of consciousness. Outcomes at each time point will be compared using mixed-effects linear regression models adjusted for baseline scores, sex and age.

This is the first RCT to apply deconstructive meditation techniques to evaluate their effect on the general population. The positive results of this project may have an important impact on the development of new interventions, not only to improve happiness and well-being in healthy populations but also potentially for the prevention and treatment of psychological and medical disorders, creating a new paradigm in the context of third-generation psychological interventions.

Registry
clinicaltrials.gov
Start Date
February 11, 2023
End Date
December 30, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital Miguel Servet
Responsible Party
Principal Investigator
Principal Investigator

Javier Garcia Campayo

Principal Investigator

Hospital Miguel Servet

Eligibility Criteria

Inclusion Criteria

  • Older than 18 years of age
  • No psychiatric diagnosis (self-reported)
  • More than 1 year's experience of daily meditation practice
  • Having a computer and Internet connection at home
  • Being able to read and understand the Spanish language
  • Willingness to participate in the study and sign the written informed consent form

Exclusion Criteria

  • Any diagnosis of a disease that may affect the central nervous system (pathological condition affecting the brain, traumatic brain injury, dementia) or other psychiatric diagnoses or acute psychiatric illnesses (severe range of depression, substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders), except for anxiety disorder
  • Any medical, infectious or degenerative disease that may affect mood; presence of delusional ideas; and hallucinations consistent or not with mood and suicide risk
  • Taking any psychiatric medication.

Outcomes

Primary Outcomes

The Nondual Embodiment Thematic Inventory (NETI)

Time Frame: Six-months follow-up

In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness

Secondary Outcomes

  • Positive and Negative Affect Schedule (PANAS)(Six-months follow-up)
  • The Nondual Awareness Dimensional Assessment (NADA)(Six-months follow-up)
  • The Pemberton Happiness Index (PHI)(Six-months follow-up)
  • Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.(Baseline)
  • The Five Facet Mindfulness Questionnaire (FFMQ)(Six-months follow-up)
  • Sussex-Oxford Compassion Scales (SOCS)(Six-months follow-up)
  • Altered state of consciousness rating scale (OAV)(Six-months follow-up)

Study Sites (1)

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