NCT05317754

Brief Summary

The efficacy of interventions based on mindfulness and compassion has been demonstrated in both clinical and general population, and in different social contexts. These interventions include so-called attentional and constructive meditation practices, respectively. However, unlike these, there is a third group, known as deconstructive meditation practices, which has not been scientifically studied. Deconstructive practices aim to undo maladaptive cognitive patterns and generate knowledge about internal models of oneself, others and the world. Although there are theoretical and philosophical studies on the origin of addiction to the self or on the mechanisms of action associated with the deconstruction of the self, there are no randomized controlled trials evaluating these techniques in either a healthy population or clinical samples. This study aims to evaluate the effect of three deconstructive techniques by comparing them to the practice of mindfulness in the general population. A randomized controlled clinical trial (RCT) will be conducted with about 240 participants allocated (1:1:1:1) to four groups: a) mindful breathing, b) prostrations, according to Tibetan Buddhist tradition; c) the Koan Mu, according to Zen Buddhist tradition; and d) the mirror exercise, according to Toltec tradition. The primary outcome will be the qualities of the non-dual experience and spiritual awakening, measured by the Nondual Embodiment Thematic Inventory, assessed at pre and post-treatment and at 3 and 6-month follow ups. Other outcomes will be mindfulness, happiness, compassion, affectivity and altered state of consciousness. Outcomes at each time point will be compared using mixed-effects linear regression models adjusted for baseline scores, sex and age. This is the first RCT to apply deconstructive meditation techniques to evaluate their effect on the general population. The positive results of this project may have an important impact on the development of new interventions, not only to improve happiness and well-being in healthy populations but also potentially for the prevention and treatment of psychological and medical disorders, creating a new paradigm in the context of third-generation psychological interventions.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

February 11, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

March 31, 2022

Last Update Submit

September 10, 2025

Conditions

Keywords

Deconstructive meditation practicesMindfulnessRandomized controlled trialWellbeingSelf-deconstruction

Outcome Measures

Primary Outcomes (16)

  • 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 Outcomes (100)

  • Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.

    Baseline

  • Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.

    Baseline

  • Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.

    Baseline

  • Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.

    Baseline

  • The Nondual Awareness Dimensional Assessment (NADA)

    Baseline

  • +95 more secondary outcomes

Study Arms (4)

Mindful breathing

EXPERIMENTAL
Behavioral: Mindful breathing

Prostrations, according to Tibetan Buddhist tradition

EXPERIMENTAL
Behavioral: Prostrations, according to Tibetan Buddhist tradition

The Koan Mu, according to Zen Buddhist tradition

EXPERIMENTAL
Behavioral: The Koan Mu, according to Zen Buddhist tradition

The mirror exercise, according to Toltec tradition

EXPERIMENTAL
Behavioral: The mirror exercise, according to Toltec tradition

Interventions

* 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.

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.

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.

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.

The mirror exercise, according to Toltec tradition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 8, 2022

Study Start

February 11, 2023

Primary Completion

March 30, 2025

Study Completion

December 30, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations