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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Feeding your demons practice
  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.
• Поведенческое Mindfulness practice
  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.

Первичные конечные точки

• Delusion of Me Index (DoM) [Срок оценки: From baseline to 6-month follow-up]
• Nondual Awareness Dimensional Assessment (NADA) [Срок оценки: From baseline to 6-month follow-up]
• Body Appreciation Scale-2 (BAS-2) [Срок оценки: From baseline to 6-month follow-up]
• Body Shape Questionnaire-10 (BSQ-10) [Срок оценки: From baseline to 6-month follow-up]

Вторичные конечные точки (6)

• Pemberton Happiness Index (PHI) [Срок оценки: From baseline to 6-month follow-up]
• SOCS-S Sussex-Oxford Self- Compassion Scale [Срок оценки: From baseline to 6-month follow-up]
• Five Facet Mindfulness Questionnaire (FFMQ). [Срок оценки: From baseline to 6-month follow-up]
• Body Image Acceptance and Action Questionnaire (BI-AAQ-5). [Срок оценки: From baseline to 6-month follow-up]
• Sussex- Oxford Compassion Scale (SOCS - O) [Срок оценки: From baseline to 6-month follow-up]
• Multidimensional Assessment of Interoceptive Awareness (MAIA) [Срок оценки: From baseline to 6-month follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Department of Psychiatry. Miguel Servet University Hospital — Zaragoza
• University of Zaragoza — Zaragoza

Идентификаторы

NCT: NCT06950905 · PI25/008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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