Mental HealthNCT06950905
Contemplative Practice for Well-being and Self-Deconstruction in Women
A study testing Feeding your demons practice and Mindfulness practice in people with Mental Health and Self Concept, run by Hospital Miguel Servet at 2 sites in Spain.
Trial summary
This randomized controlled trial aims to evaluate the effectiveness of a contemplative practice called Feeding Your Demons (FYD), based on a secular adaptation of Tibetan Buddhism, in improving psychological well-being, body image, body acceptance, compassion, and self-deconstruction in adult women. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Mental Health, Self Concept, Body Dissatisfaction
- What is being tested?
- Feeding your demons practice and Mindfulness practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesSpain
- Study dates
- 18 Jun 2025to 30 Jun 2028
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Not yet recruiting
Department of Psychiatry. Miguel Servet University Hospital
Zaragoza, Zaragoza, 50009
Javier García Campayo, 976 50 65 78, investigaprimaria@gmail.com
Javier García Campayo
- Recruiting
University of Zaragoza
Zaragoza, Zaragoza, 50009
Javier García Campayo, Doctor, 976761714, investigacioncontemplativa@gmail.com
investigacioncontemplativa@gmail.com
About this study
Official title: Effectiveness of a Contemplative Practice on Psychological Well-Being, Self-Deconstruction, Body Image, Body Acceptance, and Compassion in Women
This randomized controlled trial aims to evaluate the effectiveness of a contemplative practice called Feeding Your Demons (FYD), based on a secular adaptation of Tibetan Buddhism, in improving psychological well-being, body image, body acceptance, compassion, and self-deconstruction in adult women. Participants will be randomly assigned to either FYD or an active control group practicing mindfulness meditation. Psychological variables will be assessed before and after the intervention, and at a six-month follow-up. Additionally, a qualitative exploration will be conducted through interviews with a subgroup of participants.
Read the 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.
- Conditions
- Mental Health, Self Concept, Body Dissatisfaction, Compassion, Self-Perception, Mindfulness Meditation
- Being tested
- Feeding your demons practice, Mindfulness practice
- Keywords
- Feeding Your Demons, Self-Deconstruction, Selflessness, Contemplative Practices, Meditation, Compassion, Body Image, Women's Mental Health, Randomized Controlled Trial (RCT), mindfulness, psychological well-being
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding your demons practiceBehavioural
Also called Feeding your demons, FYD
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.
Mindfulness practiceBehavioural
Also called Mindfulness, Mindfulness meditation, Attentional meditation
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.
| Study group | Role | What they receive |
|---|---|---|
| Feeding Your Demons practice | Experimental | 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. Receives: Behavioral: Feeding your demons practice |
| Mindfulness Meditation condition | Active comparator | 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. Receives: Behavioral: Mindfulness practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delusion of Me Index (DoM)
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.
Measured: From baseline to 6-month follow-up
Nondual Awareness Dimensional Assessment (NADA)
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.
Measured: From baseline to 6-month follow-up
Body Appreciation Scale-2 (BAS-2)
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.
Measured: From baseline to 6-month follow-up
Body Shape Questionnaire-10 (BSQ-10)
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.
Measured: From baseline to 6-month follow-up
Secondary outcomes (6)
Pemberton Happiness Index (PHI)
Change in Psychological Well- Being
Measured: From baseline to 6-month follow-up
SOCS-S Sussex-Oxford Self- Compassion Scale
Change in Self - Compassion
Measured: From baseline to 6-month follow-up
Five Facet Mindfulness Questionnaire (FFMQ).
Change in Mindfulness
Measured: From baseline to 6-month follow-up
Body Image Acceptance and Action Questionnaire (BI-AAQ-5).
Change in Body Acceptance
Measured: From baseline to 6-month follow-up
Sussex- Oxford Compassion Scale (SOCS - O)
Change in Compassion (for others)
Measured: From baseline to 6-month follow-up
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Change in Interoceptive Awareness
Measured: From baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start18 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Garcia Campayo, Hospital Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950905
- Sponsor's protocol ID
- PI25/008
- Status last verified
- Sep 2025
- First submitted
- 2 Apr 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Contemplative Practice on Psychological Well-Being, Self-Deconstruction, Body Image, Body Acceptance, and Compassion in Women
- ClinicalTrials.gov ID
- NCT06950905
- Acronym / sponsor ID
- PI25/008
- Conditions
- Mental Health, Self Concept, Body Dissatisfaction, Compassion, Self-Perception, Mindfulness Meditation
- Keywords
- Feeding Your Demons, Self-Deconstruction, Selflessness, Contemplative Practices, Meditation, Compassion, Body Image, Women's Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Hospital Miguel ServetUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to evaluate the effectiveness of a contemplative practice called Feeding Your Demons (FYD), based on a secular adaptation of Tibetan Buddhism, in improving psychological well-being, body image, body acceptance, compassion, and self-deconstruction in adult women. Participants will be randomly assigned to either FYD or an active control group practicing mindfulness meditation. Psychological variables will be assessed before and after the intervention, and at a six-month follow-up. Additionally, a qualitative exploration will be conducted through interviews with a subgroup of participants.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feeding Your Demons practice | Experimental | Behavioral: Feeding your demons practiceThe 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. |
| Mindfulness Meditation condition | Active comparator | Behavioral: Mindfulness practiceThe 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeding your demons practiceAlso: Feeding your demons, FYDThe 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. | Behavioural | Feeding Your Demons practice |
| Mindfulness practiceAlso: Mindfulness, Mindfulness meditation, Attentional meditationThe 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. | Behavioural | Mindfulness Meditation condition |
Primary outcome
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.
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.
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.
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.
6 secondary outcomes
Pemberton Happiness Index (PHI)
Time frame: From baseline to 6-month follow-up
SOCS-S Sussex-Oxford Self- Compassion Scale
Time frame: From baseline to 6-month follow-up
Five Facet Mindfulness Questionnaire (FFMQ).
Time frame: 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
Sussex- Oxford Compassion Scale (SOCS - O)
Time frame: From baseline to 6-month follow-up
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: From baseline to 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding your demons practice and Mindfulness practice in people with Mental Health and Self Concept, run by Hospital Miguel Servet at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 10 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 2 sites 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?
Contact Javier Garcia Campayo (976 50 65 78, investigaprimaria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delusion of Me Index (DoM) (time frame: From baseline to 6-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.