Clinical trial NCT06950905: Contemplative Practice for Well-being and Self-Deconstruction in Women
Official title: Effectiveness of a Contemplative Practice on Psychological Well-Being, Self-Deconstruction, Body Image, Body Acceptance, and Compassion in Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 122
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delusion of Me Index (DoM)
timeFrame: From baseline to 6-month follow-up
measure: Nondual Awareness Dimensional Assessment (NADA)
timeFrame: From baseline to 6-month follow-up
measure: Body Appreciation Scale-2 (BAS-2)
timeFrame: From baseline to 6-month follow-up
measure: Body Shape Questionnaire-10 (BSQ-10)
timeFrame: From baseline to 6-month follow-up
Secondary outcomes:
measure: Pemberton Happiness Index (PHI)
timeFrame: From baseline to 6-month follow-up
measure: SOCS-S Sussex-Oxford Self- Compassion Scale
timeFrame: From baseline to 6-month follow-up
measure: Five Facet Mindfulness Questionnaire (FFMQ).
timeFrame: From baseline to 6-month follow-up
measure: Body Image Acceptance and Action Questionnaire (BI-AAQ-5).
timeFrame: From baseline to 6-month follow-up
measure: Sussex- Oxford Compassion Scale (SOCS - O)
timeFrame: From baseline to 6-month follow-up
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: From baseline to 6-month follow-up
Other outcomes:
measure: Participant Age
timeFrame: At baseline
measure: Place of Residence
timeFrame: At baseline
measure: Education Level
timeFrame: At baseline
measure: Employment Status
timeFrame: At baseline
measure: Prior Meditation Experience
timeFrame: At baseline
measure: Number of Meditation Session
timeFrame: During the 8-week intervention
measure: Perceived Quality of Meditation Practice
timeFrame: During the 8-week intervention
measure: Self-reported Affective State after Practice
timeFrame: During the 8-week intervention
measure: Qualitative phenomenological exploration
timeFrame: From baseline to post-intervention (8 weeks after baseline)
Locations:
city: Zaragoza
country: Spain
facility: Department of Psychiatry. Miguel Servet University Hospital
Study officials:
References: