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NCT Number: NCT06950905

Contemplative Practice for Well-being and Self-Deconstruction 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.

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Key information

Conditions

Mental Health Behavior Body Dissatisfaction Compassion Meditation Mindfulness Meditation Personal Satisfaction Psychological Well-Being Self Concept Self-Perception

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feeding your demons practice

Behavioral

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: Feeding your demons, FYD

Mindfulness Practice

Behavioral

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: Mindfulness, Mindfulness meditation, Attentional meditation

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Pemberton Happiness Index (PHI)

    Time frame: From baseline to 6-month follow-up

    Change in Psychological Well- Being

  2. SOCS-S Sussex-Oxford Self- Compassion Scale

    Time frame: From baseline to 6-month follow-up

    Change in Self - Compassion

  3. Five Facet Mindfulness Questionnaire (FFMQ).

    Time frame: From baseline to 6-month follow-up

    Change in Mindfulness

  4. Body Image Acceptance and Action Questionnaire (BI-AAQ-5).

    Time frame: From baseline to 6-month follow-up

    Change in Body Acceptance

  5. Sussex- Oxford Compassion Scale (SOCS - O)

    Time frame: From baseline to 6-month follow-up

    Change in Compassion (for others)

  6. Multidimensional Assessment of Interoceptive Awareness (MAIA)

    Time frame: From baseline to 6-month follow-up

    Change in Interoceptive Awareness

Other outcomes

  1. Participant Age

    Time frame: At baseline

    Age of participants, measured in years.

  2. Place of Residence

    Time frame: At baseline

    The place of residence (e.g., community or city) of participants will be recorded at baseline.

  3. Education Level

    Time frame: At baseline

    Participants will report their highest completed education level at baseline.

  4. Employment Status

    Time frame: At baseline

    Employment status (e.g., employed, unemployed, student) will be collected at baseline.

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Javier Garcia Campayo

CONTACT

[email protected]

976 50 65 78

Sponsors and collaborators

Lead sponsor

Hospital Miguel Servet

Other

Registry information

Official study title

Effectiveness of a Contemplative Practice on Psychological Well-Being, Self-Deconstruction, Body Image, Body Acceptance, and Compassion in Women

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Apr 30, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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