Effectiveness of a Contemplative Practice on Psychological Well-Being, Self-Deconstruction, Body Image, Body Acceptance, and Compassion in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 4
- 主要终点
- Delusion of Me Index (DoM)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Feeding Your Demons practice
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.
干预措施: Feeding your demons practice (Behavioral)
Mindfulness Meditation condition
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.
干预措施: Mindfulness practice (Behavioral)
结局指标
主要结局
Delusion of Me Index (DoM)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Multidimensional Assessment of Interoceptive Awareness (MAIA)(From baseline to 6-month follow-up)
- 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)
研究者
Javier Garcia Campayo
Principal Investigator
Hospital Miguel Servet