Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-12 @ 5:57 AM
Study NCT ID:
NCT06950905
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contemplative Practice for Well-being and Self-Deconstruction in Women
Sponsor:
Hospital Miguel Servet
Organization:
Study Overview
Official Title:
Effectiveness of a Contemplative Practice on Psychological Well-Being, Self-Deconstruction, Body Image, Body Acceptance, and Compassion in Women
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: