- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06950905
Contemplative Practice for Well-being and Self-Deconstruction in Women
Effectiveness of a Contemplative Practice on Psychological Well-Being, Self-Deconstruction, Body Image, Body Acceptance, and Compassion in Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Feeding Your Demons (FYD) is a secular contemplative practice inspired by the Tibetan Buddhist tradition, integrating elements of mindfulness, compassion, and symbolic visualization. The practice offers a guided process through which individuals face internal difficulties-referred to as "demons"-and transform them through acceptance and self-compassion.
This study aims to evaluate the effectiveness of FYD compared to a mindfulness meditation intervention. It is a randomized controlled trial (RCT) with two parallel groups. A total of 122 adult women will participate. Participants will be randomly assigned to either the FYD group or the control group. Both interventions will be delivered online over eight weeks.
Variables assessed include psychological well-being, body image, body acceptance, mindfulness, compassion, and self-deconstruction. Assessments will be conducted before and after the intervention, and at a six-month follow-up.
Statistical analyses will include intra- and intergroup comparisons using repeated measures analysis of variance. Parametric or non-parametric tests will be applied depending on the assumptions met. Relationships between variables will also be analyzed through correlations. Effect sizes will be calculated to estimate the magnitude of observed changes. The significance level will be set at p < .05, with a 95% confidence interval.
This study adopts a mixed-methods approach, combining quantitative assessments with qualitative interviews conducted with a subgroup of participants. Although the data are collected complementarily, their analysis and dissemination may be conducted separately or integratively, depending on the specific goals of each research phase.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Javier García Campayo
- Phone Number: 976 50 65 78
- Email: investigaprimaria@gmail.com
Study Locations
-
-
Zaragoza
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Zaragoza, Zaragoza, Spain, 50009
- Recruiting
- University of Zaragoza
-
Contact:
- Javier García Campayo, Doctor
- Phone Number: 976761714
- Email: investigacioncontemplativa@gmail.com
-
Contact:
-
Zaragoza, Zaragoza, Spain, 50009
- Not yet recruiting
- Department of Psychiatry. Miguel Servet University Hospital
-
Contact:
- Javier García Campayo
- Phone Number: 976 50 65 78
- Email: investigaprimaria@gmail.com
-
Principal Investigator:
- Javier García Campayo
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Principal Investigator:
- Paulina Lamas Morales
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Principal Investigator:
- Yolanda López del Hoyo
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Sex assigned female at birth and self-identifies as a woman
- Aged between 30 and 60 years
- Spanish nationality, or residency in Spain for more than 5 years
- Fluent in Spanish
- At least one month of experience with meditation or mindfulness practices, with a regular practice of more than 15 minutes per session
- Provides informed consent
Exclusion Criteria:
- Indicators of eating disorders (ED) or mental health deterioration, determined by the following cut-off points: SCOFF ≥ 2 and PHQ-9 ≥ 10
- Formal diagnosis of an eating disorder or any psychiatric condition
- Substance use disorder
- History of neurological disease diagnosis
- Participant's decision to withdraw from the study at any point
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feeding Your Demons practice
The experimental group will engage in a "Feeding Your Demons" contemplative practice involving repeated sessions (30-60 minutes each). The practice follows this structured protocol across sessions: Preparation: Preparation: Comfortable sitting posture in a chair, with an empty chair in front. Theme/Visualization: Identify a challenge (e.g., self-criticism, body dissatisfaction), observe bodily sensations, personify as a "demon" (note traits). Dialogue: Shift chairs, embody the demon, answer: What do you want? Need? How will you feel when fulfilled? Transformation: Return, dissolve demon into "nectar" (embodying its need), feed until it becomes an ally. Ally Engagement: Note ally's traits, ask: How will you help/protect? What promise? How to access you? Briefly embody ally. Closure: Ally dissolves into participant; and both dissolves and rest in present-moment awareness. |
The Feeding Your Demons (FYD) is a contemplative practice based on the Tibetan Buddhist tradition, adapted in a secular form.
The intervention is online and lasts a total of 8 weeks.
During this period, participants will engage in weekly home practice of the FYD method using guided audio.
The intervention includes 3 expert-facilitated sessions: an initial individual session, a group session at week 4, and a final group session at week 8.
Other Names:
|
|
Active Comparator: Mindfulness Meditation condition
The control group will engage in a mindfulness meditation intervention involving repeated sessions (30-60 minutes each). The practice follows this structured protocol across sessions: Preparation and Posture: Participants adopt a comfortable seated position with an upright spinal alignment. Breath Awareness: Sustained attention is directed toward natural respiratory rhythms without deliberate modulation. Body Scan: Systematic observation of somatic states (e.g., tension or relaxation) across distinct anatomical regions. Observation of Thoughts and Emotions: Transient cognitive and affective phenomena are acknowledged with non-judgmental detachment, avoiding engagement. Closure: Each session concludes with a return to breath-centered focus and gradual reorientation to the external environment. |
The control group will undergo an online mindfulness meditation intervention, lasting a total of 8 weeks.
It includes 3 expert-facilitated sessions: an initial individual session, a group session at week 4, and a final group session at week 8. Participants will engage in weekly home practice of mindfulness meditation using guided audio.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delusion of Me Index (DoM)
Time Frame: From baseline to 6-month follow-up
|
The primary outcome will be the change in self-related perception from baseline to 6-month follow-up after randomisation.
This includes changes in acceptance, decentering, and non-attachment.
Participants will complete this measure at three time points: baseline (week 0), post-intervention (week 8), and 6-month follow-up.
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From baseline to 6-month follow-up
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|
Nondual Awareness Dimensional Assessment (NADA)
Time Frame: From baseline to 6-month follow-up
|
The primary outcome will be the change in self-related perception from baseline to 6-month follow-up after randomisation.
This outcome includes changes in nondual awareness.
Participants will complete this measure at three time points: baseline (week 0), post-intervention (week 8), and 6-month follow-up.
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From baseline to 6-month follow-up
|
|
Body Appreciation Scale-2 (BAS-2)
Time Frame: From baseline to 6-month follow-up
|
The second primary outcome will be the change in body image from baseline to 6-month follow-up after randomisation.
This includes improvements in positive body image, specifically body appreciation.
Participants will complete this measure at three time points: baseline (week 0), post-intervention (week 8), and 6-month follow-up.
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From baseline to 6-month follow-up
|
|
Body Shape Questionnaire-10 (BSQ-10)
Time Frame: From baseline to 6-month follow-up
|
The second primary outcome will be the change in body image from baseline to 6-month follow-up after randomisation.
This includes reductions in negative body image, specifically body dissatisfaction.
Participants will complete this measure at three time points: baseline (week 0), post-intervention (week 8), and 6-month follow-up.
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From baseline to 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pemberton Happiness Index (PHI)
Time Frame: From baseline to 6-month follow-up
|
Change in Psychological Well- Being
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From baseline to 6-month follow-up
|
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SOCS-S Sussex-Oxford Self- Compassion Scale
Time Frame: From baseline to 6-month follow-up
|
Change in Self - Compassion
|
From baseline to 6-month follow-up
|
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Five Facet Mindfulness Questionnaire (FFMQ).
Time Frame: From baseline to 6-month follow-up
|
Change in Mindfulness
|
From baseline to 6-month follow-up
|
|
Body Image Acceptance and Action Questionnaire (BI-AAQ-5).
Time Frame: From baseline to 6-month follow-up
|
Change in Body Acceptance
|
From baseline to 6-month follow-up
|
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Sussex- Oxford Compassion Scale (SOCS - O)
Time Frame: From baseline to 6-month follow-up
|
Change in Compassion (for others)
|
From baseline to 6-month follow-up
|
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Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time Frame: From baseline to 6-month follow-up
|
Change in Interoceptive Awareness
|
From baseline to 6-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Age
Time Frame: At baseline
|
Age of participants, measured in years.
|
At baseline
|
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Place of Residence
Time Frame: At baseline
|
The place of residence (e.g., community or city) of participants will be recorded at baseline.
|
At baseline
|
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Education Level
Time Frame: At baseline
|
Participants will report their highest completed education level at baseline.
|
At baseline
|
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Employment Status
Time Frame: At baseline
|
Employment status (e.g., employed, unemployed, student) will be collected at baseline.
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At baseline
|
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Prior Meditation Experience
Time Frame: At baseline
|
Participants will report whether they have prior meditation experience (yes/no) and, if applicable, the number of months or years of practice.Additionally, they will indicate the type of meditation practice previously performed (e.g., mindfulness, compassion, other).
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At baseline
|
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Number of Meditation Session
Time Frame: During the 8-week intervention
|
Participants will indicate the sequential number of each formal meditation session completed during the 8-week intervention (e.g., Session 1, Session 2, Session 3).
|
During the 8-week intervention
|
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Perceived Quality of Meditation Practice
Time Frame: During the 8-week intervention
|
After each formal meditation session, participants will rate the perceived quality of their practice on a scale from 0 (very poor) to 10 (excellent).
|
During the 8-week intervention
|
|
Self-reported Affective State after Practice
Time Frame: During the 8-week intervention
|
Participants will rate their affective state immediately after each formal meditation session on a scale from 0 (very negative) to 10 (very positive).
|
During the 8-week intervention
|
|
Qualitative phenomenological exploration
Time Frame: From baseline to post-intervention (8 weeks after baseline)
|
Semi-structured micro-phenomenological interviews will be conducted at baseline and immediately after the 8-week intervention to explore participants' lived experience related to self-perception, embodiment, and contemplative transformation.
These data are exploratory and will not be included in inferential statistical analyses.
|
From baseline to post-intervention (8 weeks after baseline)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI25/008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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