Clinical trial NCT05317754: Effectiveness of Four Deconstructive Meditative Practices on Well-being and Self-deconstruction
Official title: Effectiveness of Four Deconstructive Meditative Practices on Well-being and Self-deconstruction: An Exploratory Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Wellness
Keywords: Deconstructive meditation practices
Mindfulness
Randomized controlled trial
Wellbeing
Self-deconstruction
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. Any medical, infectious or degenerative disease that may affect mood; presence of delusional ideas; and hallucinations consistent or not with mood and suicide risk
3. Taking any psychiatric medication.

Primary outcomes:
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Baseline
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Post-treatment 60 days from baseline
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Three-months follow-up
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Six-months follow-up
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Baseline
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Post-treatment 60 days from baseline
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Three-months follow-up
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Six-months follow-up
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Baseline
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Post-treatment 60 days from baseline
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Three-months follow-up
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Six-months follow-up
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Baseline
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Post-treatment 60 days from baseline
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Three-months follow-up
measure: The Nondual Embodiment Thematic Inventory (NETI)
timeFrame: Six-months follow-up
Secondary outcomes:
measure: Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.
timeFrame: Baseline
measure: Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.
timeFrame: Baseline
measure: Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.
timeFrame: Baseline
measure: Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.
timeFrame: Baseline
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Baseline
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Post-treatment 60 days from baseline
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Three-months follow-up
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Six-months follow-up
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Baseline
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Post-treatment 60 days from baseline
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Three-months follow-up
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Six-months follow-up
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Baseline
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Post-treatment 60 days from baseline
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Three-months follow-up
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Six-months follow-up
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Baseline
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Post-treatment 60 days from baseline
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Three-months follow-up
measure: The Nondual Awareness Dimensional Assessment (NADA)
timeFrame: Six-months follow-up
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Post-treatment 60 days from baseline
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Three-months follow-up
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Six-months follow-up
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Post-treatment 60 days from baseline
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Three-months follow-up
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Six-months follow-up
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Post-treatment 60 days from baseline
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Three-months follow-up
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Six-months follow-up
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Post-treatment 60 days from baseline
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Three-months follow-up
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Six-months follow-up
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Baseline
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Post-treatment 60 days from baseline
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Three-months follow-up
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Six-months follow-up
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Baseline
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Post-treatment 60 days from baseline
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Three-months follow-up
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Six-months follow-up
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Baseline
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Post-treatment 60 days from baseline
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Three-months follow-up
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Six-months follow-up
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Baseline
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Post-treatment 60 days from baseline
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Three-months follow-up
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Six-months follow-up
measure: The Pemberton Happiness Index (PHI)
timeFrame: Baseline
measure: The Pemberton Happiness Index (PHI)
timeFrame: Post-treatment 60 days from baseline
measure: The Pemberton Happiness Index (PHI)
timeFrame: Three-months follow-up
measure: The Pemberton Happiness Index (PHI)
timeFrame: Six-months follow-up
measure: The Pemberton Happiness Index (PHI)
timeFrame: Baseline
measure: The Pemberton Happiness Index (PHI)
timeFrame: Post-treatment 60 days from baseline
measure: The Pemberton Happiness Index (PHI)
timeFrame: Three-months follow-up
measure: The Pemberton Happiness Index (PHI)
timeFrame: Six-months follow-up
measure: The Pemberton Happiness Index (PHI)
timeFrame: Baseline
measure: The Pemberton Happiness Index (PHI)
timeFrame: Post-treatment 60 days from baseline
measure: The Pemberton Happiness Index (PHI)
timeFrame: Three-months follow-up
measure: The Pemberton Happiness Index (PHI)
timeFrame: Six-months follow-up
measure: The Pemberton Happiness Index (PHI)
timeFrame: Baseline
measure: The Pemberton Happiness Index (PHI)
timeFrame: Post-treatment 60 days from baseline
measure: The Pemberton Happiness Index (PHI)
timeFrame: Three-months follow-up
measure: The Pemberton Happiness Index (PHI)
timeFrame: Six-months follow-up
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Post-treatment 60 days from baseline
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Three-months follow-up
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Six-months follow-up
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Post-treatment 60 days from baseline
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Three-months follow-up
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Six-months follow-up
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Post-treatment 60 days from baseline
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Three-months follow-up
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Six-months follow-up
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Post-treatment 60 days from baseline
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Three-months follow-up
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Six-months follow-up
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Baseline
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Post-treatment 60 days from baseline
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Three-months follow-up
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Six-months follow-up
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Baseline
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Post-treatment 60 days from baseline
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Three-months follow-up
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Six-months follow-up
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Baseline
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Post-treatment 60 days from baseline
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Three-months follow-up
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Six-months follow-up
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Baseline
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Post-treatment 60 days from baseline
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Three-months follow-up
measure: Altered state of consciousness rating scale (OAV)
timeFrame: Six-months follow-up
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Department of Psychiatry. Miguel Servet University Hospital
Study officials:
References: