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临床试验/NCT05317754
NCT05317754进行中(未招募)不适用

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

Hospital Miguel Servet2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
240
试验地点
2
主要终点
The Nondual Embodiment Thematic Inventory (NETI)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

The Nondual Embodiment Thematic Inventory (NETI)

时间窗: Six-months follow-up

In the mindful breathing 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

次要结局

  • The Nondual Awareness Dimensional Assessment (NADA)(Six-months follow-up)
  • Positive and Negative Affect Schedule (PANAS)(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)
  • Altered state of consciousness rating scale (OAV)(Six-months follow-up)
  • Sussex-Oxford Compassion Scales (SOCS)(Six-months follow-up)
  • The Pemberton Happiness Index (PHI)(Six-months follow-up)

研究者

发起方
Hospital Miguel Servet
申办方类型
Other
责任方
Principal Investigator
主要研究者

Javier Garcia Campayo

Principal Investigator

Hospital Miguel Servet

研究点 (2)

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