Effectiveness of Four Deconstructive Meditative Practices on Well-being and Self-deconstruction

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mental Health Wellness
• Intervention / Treatment: Behavioral: Mindful breathing; Behavioral: Prostrations, according to Tibetan Buddhist tradition; Behavioral: The Koan Mu, according to Zen Buddhist tradition; Behavioral: The mirror exercise, according to Toltec tradition

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Department of Psychiatry. Miguel Servet University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindful breathing	Behavioral: Mindful breathing; Formal practice should take 30-60 minutes/day. It can be divided into as many as 4 sessions/day at times of participants' choosing, but the recommended times are after waking up in the morning and before going to bed at night.; There is no limit to the number of times informal practice can be performed during the day.; Use of a diary is necessary to record the time and duration of all formal and informal practices.; The intervention will have a duration of 60 days. During this period, participants are to take part only in the intervention to which they have been randomized and no other. After this period of time and during the follow-up, participants will be able to practise any kind of meditation and at times of their choosing, but this information must always be recorded in their diary.
Experimental: Prostrations, according to Tibetan Buddhist tradition	Behavioral: Prostrations, according to Tibetan Buddhist tradition; Formal practice should take 30-60 minutes/day. It can be divided into as many as 4 sessions/day at times of participants' choosing, but the recommended times are after waking up in the morning and before going to bed at night.; There is no limit to the number of times informal practice can be performed during the day.; Use of a diary is necessary to record the time and duration of all formal and informal practices.; The intervention will have a duration of 60 days. During this period, participants are to take part only in the intervention to which they have been randomized and no other. After this period of time and during the follow-up, participants will be able to practise any kind of meditation and at times of their choosing, but this information must always be recorded in their diary.
Experimental: The Koan Mu, according to Zen Buddhist tradition	Behavioral: The Koan Mu, according to Zen Buddhist tradition; Formal practice should take 30-60 minutes/day. It can be divided into as many as 4 sessions/day at times of participants' choosing, but the recommended times are after waking up in the morning and before going to bed at night.; There is no limit to the number of times informal practice can be performed during the day.; Use of a diary is necessary to record the time and duration of all formal and informal practices.; The intervention will have a duration of 60 days. During this period, participants are to take part only in the intervention to which they have been randomized and no other. After this period of time and during the follow-up, participants will be able to practise any kind of meditation and at times of their choosing, but this information must always be recorded in their diary.
Experimental: The mirror exercise, according to Toltec tradition	Behavioral: The mirror exercise, according to Toltec tradition; Formal practice should take 30-60 minutes/day. It can be divided into as many as 4 sessions/day at times of participants' choosing, but the recommended times are after waking up in the morning and before going to bed at night.; There is no limit to the number of times informal practice can be performed during the day.; Use of a diary is necessary to record the time and duration of all formal and informal practices.; The intervention will have a duration of 60 days. During this period, participants are to take part only in the intervention to which they have been randomized and no other. After this period of time and during the follow-up, participants will be able to practise any kind of meditation and at times of their choosing, but this information must always be recorded in their diary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Nondual Embodiment Thematic Inventory (NETI)	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	Baseline
The Nondual Embodiment Thematic Inventory (NETI)	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	Post-treatment 60 days from baseline
The Nondual Embodiment Thematic Inventory (NETI)	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	Three-months follow-up
The Nondual Embodiment Thematic Inventory (NETI)	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	Six-months follow-up
The Nondual Embodiment Thematic Inventory (NETI)	In the prostrations, according to Tibetan Buddhist 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	Baseline
The Nondual Embodiment Thematic Inventory (NETI)	In the prostrations, according to Tibetan Buddhist 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	Post-treatment 60 days from baseline
The Nondual Embodiment Thematic Inventory (NETI)	In the prostrations, according to Tibetan Buddhist 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	Three-months follow-up
The Nondual Embodiment Thematic Inventory (NETI)	In the prostrations, according to Tibetan Buddhist 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	Six-months follow-up
The Nondual Embodiment Thematic Inventory (NETI)	In the Koan Mu, according to Zen Buddhist 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	Baseline
The Nondual Embodiment Thematic Inventory (NETI)	In the Koan Mu, according to Zen Buddhist 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	Post-treatment 60 days from baseline
The Nondual Embodiment Thematic Inventory (NETI)	In the Koan Mu, according to Zen Buddhist 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	Three-months follow-up
The Nondual Embodiment Thematic Inventory (NETI)	In the Koan Mu, according to Zen Buddhist 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	Six-months follow-up
The Nondual Embodiment Thematic Inventory (NETI)	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	Baseline
The Nondual Embodiment Thematic Inventory (NETI)	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	Post-treatment 60 days from baseline
The Nondual Embodiment Thematic Inventory (NETI)	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	Three-months follow-up
The Nondual Embodiment Thematic Inventory (NETI)	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	Six-months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.	In the mindful breathing group	Baseline
Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.	In the prostrations, according to Tibetan Buddhist tradition, group	Baseline
Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.	In the Koan Mu, according to Zen Buddhist tradition, group	Baseline
Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.	In the mirror exercise, according to Toltec tradition, group	Baseline
The Nondual Awareness Dimensional Assessment (NADA)	In the mindful breathing group	Baseline
The Nondual Awareness Dimensional Assessment (NADA)	In the mindful breathing group	Post-treatment 60 days from baseline
The Nondual Awareness Dimensional Assessment (NADA)	In the mindful breathing group	Three-months follow-up
The Nondual Awareness Dimensional Assessment (NADA)	In the mindful breathing group	Six-months follow-up
The Nondual Awareness Dimensional Assessment (NADA)	In the prostrations, according to Tibetan Buddhist tradition, group	Baseline
The Nondual Awareness Dimensional Assessment (NADA)	In the prostrations, according to Tibetan Buddhist tradition, group	Post-treatment 60 days from baseline
The Nondual Awareness Dimensional Assessment (NADA)	In the prostrations, according to Tibetan Buddhist tradition, group	Three-months follow-up
The Nondual Awareness Dimensional Assessment (NADA)	In the prostrations, according to Tibetan Buddhist tradition, group	Six-months follow-up
The Nondual Awareness Dimensional Assessment (NADA)	In the Koan Mu, according to Zen Buddhist tradition, group	Baseline
The Nondual Awareness Dimensional Assessment (NADA)	In the Koan Mu, according to Zen Buddhist tradition, group	Post-treatment 60 days from baseline
The Nondual Awareness Dimensional Assessment (NADA)	In the Koan Mu, according to Zen Buddhist tradition, group	Three-months follow-up
The Nondual Awareness Dimensional Assessment (NADA)	In the Koan Mu, according to Zen Buddhist tradition, group	Six-months follow-up
The Nondual Awareness Dimensional Assessment (NADA)	In the mirror exercise, according to Toltec tradition, group	Baseline
The Nondual Awareness Dimensional Assessment (NADA)	In the mirror exercise, according to Toltec tradition, group	Post-treatment 60 days from baseline
The Nondual Awareness Dimensional Assessment (NADA)	In the mirror exercise, according to Toltec tradition, group	Three-months follow-up
The Nondual Awareness Dimensional Assessment (NADA)	In the mirror exercise, according to Toltec tradition, group	Six-months follow-up
The Five Facet Mindfulness Questionnaire (FFMQ)	In the mindful breathing group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Baseline
The Five Facet Mindfulness Questionnaire (FFMQ)	In the mindful breathing group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Post-treatment 60 days from baseline
The Five Facet Mindfulness Questionnaire (FFMQ)	In the mindful breathing group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Three-months follow-up
The Five Facet Mindfulness Questionnaire (FFMQ)	In the mindful breathing group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Six-months follow-up
The Five Facet Mindfulness Questionnaire (FFMQ)	In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Baseline
The Five Facet Mindfulness Questionnaire (FFMQ)	In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Post-treatment 60 days from baseline
The Five Facet Mindfulness Questionnaire (FFMQ)	In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Three-months follow-up
The Five Facet Mindfulness Questionnaire (FFMQ)	In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Six-months follow-up
The Five Facet Mindfulness Questionnaire (FFMQ)	In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Baseline
The Five Facet Mindfulness Questionnaire (FFMQ)	In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Post-treatment 60 days from baseline
The Five Facet Mindfulness Questionnaire (FFMQ)	In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Three-months follow-up
The Five Facet Mindfulness Questionnaire (FFMQ)	In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Six-months follow-up
The Five Facet Mindfulness Questionnaire (FFMQ)	In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Baseline
The Five Facet Mindfulness Questionnaire (FFMQ)	In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Post-treatment 60 days from baseline
The Five Facet Mindfulness Questionnaire (FFMQ)	In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Three-months follow-up
The Five Facet Mindfulness Questionnaire (FFMQ)	In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness	Six-months follow-up
Sussex-Oxford Compassion Scales (SOCS)	In the mindful breathing group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Baseline
Sussex-Oxford Compassion Scales (SOCS)	In the mindful breathing group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Post-treatment 60 days from baseline
Sussex-Oxford Compassion Scales (SOCS)	In the mindful breathing group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Three-months follow-up
Sussex-Oxford Compassion Scales (SOCS)	In the mindful breathing group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Six-months follow-up
Sussex-Oxford Compassion Scales (SOCS)	In the prostrations, according to Tibetan Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Baseline
Sussex-Oxford Compassion Scales (SOCS)	In the prostrations, according to Tibetan Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Post-treatment 60 days from baseline
Sussex-Oxford Compassion Scales (SOCS)	In the prostrations, according to Tibetan Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Three-months follow-up
Sussex-Oxford Compassion Scales (SOCS)	In the prostrations, according to Tibetan Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Six-months follow-up
Sussex-Oxford Compassion Scales (SOCS)	In the Koan Mu, according to Zen Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Baseline
Sussex-Oxford Compassion Scales (SOCS)	In the Koan Mu, according to Zen Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Post-treatment 60 days from baseline
Sussex-Oxford Compassion Scales (SOCS)	In the Koan Mu, according to Zen Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Three-months follow-up
Sussex-Oxford Compassion Scales (SOCS)	In the Koan Mu, according to Zen Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Six-months follow-up
Sussex-Oxford Compassion Scales (SOCS)	In the mirror exercise, according to Toltec tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Baseline
Sussex-Oxford Compassion Scales (SOCS)	In the mirror exercise, according to Toltec tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Post-treatment 60 days from baseline
Sussex-Oxford Compassion Scales (SOCS)	In the mirror exercise, according to Toltec tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Three-months follow-up
Sussex-Oxford Compassion Scales (SOCS)	In the mirror exercise, according to Toltec tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Six-months follow-up
The Pemberton Happiness Index (PHI)	In the mindful breathing group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Baseline
The Pemberton Happiness Index (PHI)	In the mindful breathing group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Post-treatment 60 days from baseline
The Pemberton Happiness Index (PHI)	In the mindful breathing group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Three-months follow-up
The Pemberton Happiness Index (PHI)	In the mindful breathing group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Six-months follow-up
The Pemberton Happiness Index (PHI)	In the prostrations, according to Tibetan Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Baseline
The Pemberton Happiness Index (PHI)	In the prostrations, according to Tibetan Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Post-treatment 60 days from baseline
The Pemberton Happiness Index (PHI)	In the prostrations, according to Tibetan Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Three-months follow-up
The Pemberton Happiness Index (PHI)	In the prostrations, according to Tibetan Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Six-months follow-up
The Pemberton Happiness Index (PHI)	In the Koan Mu, according to Zen Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Baseline
The Pemberton Happiness Index (PHI)	In the Koan Mu, according to Zen Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Post-treatment 60 days from baseline
The Pemberton Happiness Index (PHI)	In the Koan Mu, according to Zen Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Three-months follow-up
The Pemberton Happiness Index (PHI)	In the Koan Mu, according to Zen Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Six-months follow-up
The Pemberton Happiness Index (PHI)	In the mirror exercise, according to Toltec tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Baseline
The Pemberton Happiness Index (PHI)	In the mirror exercise, according to Toltec tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Post-treatment 60 days from baseline
The Pemberton Happiness Index (PHI)	In the mirror exercise, according to Toltec tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Three-months follow-up
The Pemberton Happiness Index (PHI)	In the mirror exercise, according to Toltec tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being	Six-months follow-up
Positive and Negative Affect Schedule (PANAS)	In the mindful breathing group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Baseline
Positive and Negative Affect Schedule (PANAS)	In the mindful breathing group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Post-treatment 60 days from baseline
Positive and Negative Affect Schedule (PANAS)	In the mindful breathing group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Three-months follow-up
Positive and Negative Affect Schedule (PANAS)	In the mindful breathing group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Six-months follow-up
Positive and Negative Affect Schedule (PANAS)	In the prostrations, according to Tibetan Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Baseline
Positive and Negative Affect Schedule (PANAS)	In the prostrations, according to Tibetan Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Post-treatment 60 days from baseline
Positive and Negative Affect Schedule (PANAS)	In the prostrations, according to Tibetan Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Three-months follow-up
Positive and Negative Affect Schedule (PANAS)	In the prostrations, according to Tibetan Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Six-months follow-up
Positive and Negative Affect Schedule (PANAS)	In the Koan Mu, according to Zen Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Baseline
Positive and Negative Affect Schedule (PANAS)	In the Koan Mu, according to Zen Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Post-treatment 60 days from baseline
Positive and Negative Affect Schedule (PANAS)	In the Koan Mu, according to Zen Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Three-months follow-up
Positive and Negative Affect Schedule (PANAS)	In the Koan Mu, according to Zen Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Six-months follow-up
Positive and Negative Affect Schedule (PANAS)	In the mirror exercise, according to Toltec tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Baseline
Positive and Negative Affect Schedule (PANAS)	In the mirror exercise, according to Toltec tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Post-treatment 60 days from baseline
Positive and Negative Affect Schedule (PANAS)	In the mirror exercise, according to Toltec tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Three-months follow-up
Positive and Negative Affect Schedule (PANAS)	In the mirror exercise, according to Toltec tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.	Six-months follow-up
Altered state of consciousness rating scale (OAV)	In the mindful breathing group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Baseline
Altered state of consciousness rating scale (OAV)	In the mindful breathing group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Post-treatment 60 days from baseline
Altered state of consciousness rating scale (OAV)	In the mindful breathing group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Three-months follow-up
Altered state of consciousness rating scale (OAV)	In the mindful breathing group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Six-months follow-up
Altered state of consciousness rating scale (OAV)	In the prostrations, according to Tibetan Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Baseline
Altered state of consciousness rating scale (OAV)	In the prostrations, according to Tibetan Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Post-treatment 60 days from baseline
Altered state of consciousness rating scale (OAV)	In the prostrations, according to Tibetan Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Three-months follow-up
Altered state of consciousness rating scale (OAV)	In the prostrations, according to Tibetan Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Six-months follow-up
Altered state of consciousness rating scale (OAV)	In the Koan Mu, according to Zen Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Baseline
Altered state of consciousness rating scale (OAV)	In the Koan Mu, according to Zen Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Post-treatment 60 days from baseline
Altered state of consciousness rating scale (OAV)	In the Koan Mu, according to Zen Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Three-months follow-up
Altered state of consciousness rating scale (OAV)	In the Koan Mu, according to Zen Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Six-months follow-up
Altered state of consciousness rating scale (OAV)	In the mirror exercise, according to Toltec tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Baseline
Altered state of consciousness rating scale (OAV)	In the mirror exercise, according to Toltec tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Post-treatment 60 days from baseline
Altered state of consciousness rating scale (OAV)	In the mirror exercise, according to Toltec tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Three-months follow-up
Altered state of consciousness rating scale (OAV)	In the mirror exercise, according to Toltec tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.	Six-months follow-up

Collaborators and Investigators

• Sponsor: Hospital Miguel Servet

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2023
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Wellbeing; Randomized controlled trial; Mindfulness; Deconstructive meditation practices; Self-deconstruction
• Other Study ID Numbers: PI22/110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No