AzTrials
AzTrials

Mental Health WellnessNCT05317754

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

A study testing Mindful breathing, Prostrations, according to Tibetan Buddhist tradition and The Koan Mu, according to Zen Buddhist tradition in people with Mental Health Wellness, run by Hospital Miguel Servet at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health Wellness
What is being tested?
Mindful breathing, Prostrations, according to Tibetan Buddhist tradition and The Koan Mu, according to Zen Buddhist tradition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteSpain
Study dates
11 Feb 2023to 30 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Department of Psychiatry. Miguel Servet University Hospital

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: 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.

Being tested
Mindful breathing, Prostrations, according to Tibetan Buddhist tradition, The Koan Mu, according to Zen Buddhist tradition, The mirror exercise, according to Toltec tradition
Keywords
Deconstructive meditation practices, Mindfulness, Randomized controlled trial, Wellbeing, Self-deconstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindful breathingBehavioural

    • 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.
  • Prostrations, according to Tibetan Buddhist traditionBehavioural

    • 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.
  • The Koan Mu, according to Zen Buddhist traditionBehavioural

    • 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.
  • The mirror exercise, according to Toltec traditionBehavioural

    • 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.
Study groups in NCT05317754
Study groupRoleWhat they receive
Mindful breathingExperimentalNot described
Receives: Behavioral: Mindful breathing
Prostrations, according to Tibetan Buddhist traditionExperimentalNot described
Receives: Behavioral: Prostrations, according to Tibetan Buddhist tradition
The Koan Mu, according to Zen Buddhist traditionExperimentalNot described
Receives: Behavioral: The Koan Mu, according to Zen Buddhist tradition
The mirror exercise, according to Toltec traditionExperimentalNot described
Receives: Behavioral: The mirror exercise, according to Toltec tradition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

  2. 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

    Measured: Post-treatment 60 days from baseline

  3. 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

    Measured: Three-months follow-up

  4. 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

    Measured: Six-months follow-up

  5. 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

    Measured: Baseline

  6. 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

    Measured: Post-treatment 60 days from baseline

  7. 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

    Measured: Three-months follow-up

  8. 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

    Measured: Six-months follow-up

  9. 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

    Measured: Baseline

  10. 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

    Measured: Post-treatment 60 days from baseline

  11. 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

    Measured: Three-months follow-up

  12. 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

    Measured: Six-months follow-up

  13. 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

    Measured: Baseline

  14. 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

    Measured: Post-treatment 60 days from baseline

  15. 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

    Measured: Three-months follow-up

  16. 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

    Measured: Six-months follow-up

Secondary outcomes (100)
  1. 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

    Measured: Baseline

  2. 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

    Measured: Baseline

  3. 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

    Measured: Baseline

  4. 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

    Measured: Baseline

  5. The Nondual Awareness Dimensional Assessment (NADA)

    In the mindful breathing group

    Measured: Baseline

  6. The Nondual Awareness Dimensional Assessment (NADA)

    In the mindful breathing group

    Measured: Post-treatment 60 days from baseline

  7. The Nondual Awareness Dimensional Assessment (NADA)

    In the mindful breathing group

    Measured: Three-months follow-up

  8. The Nondual Awareness Dimensional Assessment (NADA)

    In the mindful breathing group

    Measured: Six-months follow-up

  9. The Nondual Awareness Dimensional Assessment (NADA)

    In the prostrations, according to Tibetan Buddhist tradition, group

    Measured: Baseline

  10. The Nondual Awareness Dimensional Assessment (NADA)

    In the prostrations, according to Tibetan Buddhist tradition, group

    Measured: Post-treatment 60 days from baseline

  11. The Nondual Awareness Dimensional Assessment (NADA)

    In the prostrations, according to Tibetan Buddhist tradition, group

    Measured: Three-months follow-up

  12. The Nondual Awareness Dimensional Assessment (NADA)

    In the prostrations, according to Tibetan Buddhist tradition, group

    Measured: Six-months follow-up

  13. The Nondual Awareness Dimensional Assessment (NADA)

    In the Koan Mu, according to Zen Buddhist tradition, group

    Measured: Baseline

  14. The Nondual Awareness Dimensional Assessment (NADA)

    In the Koan Mu, according to Zen Buddhist tradition, group

    Measured: Post-treatment 60 days from baseline

  15. The Nondual Awareness Dimensional Assessment (NADA)

    In the Koan Mu, according to Zen Buddhist tradition, group

    Measured: Three-months follow-up

  16. The Nondual Awareness Dimensional Assessment (NADA)

    In the Koan Mu, according to Zen Buddhist tradition, group

    Measured: Six-months follow-up

  17. The Nondual Awareness Dimensional Assessment (NADA)

    In the mirror exercise, according to Toltec tradition, group

    Measured: Baseline

  18. The Nondual Awareness Dimensional Assessment (NADA)

    In the mirror exercise, according to Toltec tradition, group

    Measured: Post-treatment 60 days from baseline

  19. The Nondual Awareness Dimensional Assessment (NADA)

    In the mirror exercise, according to Toltec tradition, group

    Measured: Three-months follow-up

  20. The Nondual Awareness Dimensional Assessment (NADA)

    In the mirror exercise, according to Toltec tradition, group

    Measured: Six-months follow-up

  21. 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

    Measured: Baseline

  22. 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

    Measured: Post-treatment 60 days from baseline

  23. 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

    Measured: Three-months follow-up

  24. 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

    Measured: Six-months follow-up

  25. 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

    Measured: Baseline

  26. 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

    Measured: Post-treatment 60 days from baseline

  27. 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

    Measured: Three-months follow-up

  28. 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

    Measured: Six-months follow-up

  29. 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

    Measured: Baseline

  30. 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

    Measured: Post-treatment 60 days from baseline

  31. 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

    Measured: Three-months follow-up

  32. 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

    Measured: Six-months follow-up

  33. 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

    Measured: Baseline

  34. 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

    Measured: Post-treatment 60 days from baseline

  35. 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

    Measured: Three-months follow-up

  36. 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

    Measured: Six-months follow-up

  37. 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

    Measured: Baseline

  38. 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

    Measured: Post-treatment 60 days from baseline

  39. 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

    Measured: Three-months follow-up

  40. 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

    Measured: Six-months follow-up

  41. 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

    Measured: Baseline

  42. 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

    Measured: Post-treatment 60 days from baseline

  43. 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

    Measured: Three-months follow-up

  44. 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

    Measured: Six-months follow-up

  45. 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

    Measured: Baseline

  46. 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

    Measured: Post-treatment 60 days from baseline

  47. 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

    Measured: Three-months follow-up

  48. 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

    Measured: Six-months follow-up

  49. 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

    Measured: Baseline

  50. 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

    Measured: Post-treatment 60 days from baseline

  51. 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

    Measured: Three-months follow-up

  52. 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

    Measured: Six-months follow-up

  53. 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

    Measured: Baseline

  54. 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

    Measured: Post-treatment 60 days from baseline

  55. 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

    Measured: Three-months follow-up

  56. 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

    Measured: Six-months follow-up

  57. 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

    Measured: Baseline

  58. 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

    Measured: Post-treatment 60 days from baseline

  59. 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

    Measured: Three-months follow-up

  60. 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

    Measured: Six-months follow-up

  61. 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

    Measured: Baseline

  62. 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

    Measured: Post-treatment 60 days from baseline

  63. 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

    Measured: Three-months follow-up

  64. 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

    Measured: Six-months follow-up

  65. 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

    Measured: Baseline

  66. 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

    Measured: Post-treatment 60 days from baseline

  67. 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

    Measured: Three-months follow-up

  68. 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

    Measured: Six-months follow-up

  69. 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.

    Measured: Baseline

  70. 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.

    Measured: Post-treatment 60 days from baseline

  71. 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.

    Measured: Three-months follow-up

  72. 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.

    Measured: Six-months follow-up

  73. 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.

    Measured: Baseline

  74. 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.

    Measured: Post-treatment 60 days from baseline

  75. 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.

    Measured: Three-months follow-up

  76. 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.

    Measured: Six-months follow-up

  77. 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.

    Measured: Baseline

  78. 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.

    Measured: Post-treatment 60 days from baseline

  79. 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.

    Measured: Three-months follow-up

  80. 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.

    Measured: Six-months follow-up

  81. 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.

    Measured: Baseline

  82. 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.

    Measured: Post-treatment 60 days from baseline

  83. 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.

    Measured: Three-months follow-up

  84. 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.

    Measured: Six-months follow-up

  85. 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.

    Measured: Baseline

  86. 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.

    Measured: Post-treatment 60 days from baseline

  87. 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.

    Measured: Three-months follow-up

  88. 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.

    Measured: Six-months follow-up

  89. 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.

    Measured: Baseline

  90. 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.

    Measured: Post-treatment 60 days from baseline

  91. 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.

    Measured: Three-months follow-up

  92. 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.

    Measured: Six-months follow-up

  93. 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.

    Measured: Baseline

  94. 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.

    Measured: Post-treatment 60 days from baseline

  95. 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.

    Measured: Three-months follow-up

  96. 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.

    Measured: Six-months follow-up

  97. 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.

    Measured: Baseline

  98. 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.

    Measured: Post-treatment 60 days from baseline

  99. 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.

    Measured: Three-months follow-up

  100. 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.

    Measured: Six-months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start11 Feb 2023
  3. Primary completion30 Mar 2025
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05317754
Sponsor's protocol ID
PI22/110
Status last verified
Sep 2025
First submitted
31 Mar 2022
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Garcia-Campayo J, Hijar-Aguinaga R, Lopez-Del-Hoyo Y, Magallon-Botaya R, Fernandez-Martinez S, Barcelo-Soler A, Soler-Ribaudi J, Montero-Marin J. Effectiveness of four deconstructive meditative practices on well-being and self-deconstruction: study protocol for an exploratory randomized controlled trial. Trials. 2023 Feb 20;24(1):125. doi: 10.1186/s13063-023-07151-0.

    PubMed 36805694

Questions about this trial

What is this clinical trial studying?

A study testing Mindful breathing, Prostrations, according to Tibetan Buddhist tradition and The Koan Mu, according to Zen Buddhist tradition in people with Mental Health Wellness, run by Hospital Miguel Servet at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Nondual Embodiment Thematic Inventory (NETI) (time frame: Baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05317754, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in