Contemplative Practice for Well-being and Self-Deconstruction in Women

NCT06950905 | Recruiting

• 1 other identifier: PI25/008
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Mental Health; Self Concept; Body Dissatisfaction; Compassion; Self-Perception; Mindfulness Meditation; Meditation; Psychological Well-being

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  From baseline to 6-month follow-up

Secondary Outcomes (6)

• Pemberton Happiness Index (PHI)

  From baseline to 6-month follow-up

• SOCS-S Sussex-Oxford Self- Compassion Scale

  From baseline to 6-month follow-up

• Five Facet Mindfulness Questionnaire (FFMQ).

  From baseline to 6-month follow-up

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

  From baseline to 6-month follow-up

• Sussex- Oxford Compassion Scale (SOCS - O)

  From baseline to 6-month follow-up

Other Outcomes (9)

• Participant Age

  At baseline

• Place of Residence

  At baseline

• Education Level

  At baseline

Study Arms (2)

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.

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.

Behavioral: Mindfulness practice

Interventions

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.

Also known as: Feeding your demons, FYD

Feeding Your Demons practice

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.

Also known as: Mindfulness, Mindfulness meditation, Attentional meditation

Mindfulness Meditation condition

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Only individuals who were assigned female at birth and who currently self-identify as women are eligible to participate in the study. This criterion ensures alignment with the study's focus on female embodiment, body image, and self-related perception in adult women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Miguel Servet: lead

Study Sites (2)

Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, Zaragoza, 50009, Spain

NOT YET RECRUITING

University of Zaragoza

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Javier Garcia Campayo

CONTACT

976 50 65 78; investigaprimaria@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 30, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)