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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2025-04-27', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participant Age', 'timeFrame': 'At baseline', 'description': 'Age of participants, measured in years.'}, {'measure': 'Place of Residence', 'timeFrame': 'At baseline', 'description': 'The place of residence (e.g., community or city) of participants will be recorded at baseline.'}, {'measure': 'Education Level', 'timeFrame': 'At baseline', 'description': 'Participants will report their highest completed education level at baseline.'}, {'measure': 'Employment Status', 'timeFrame': 'At baseline', 'description': 'Employment status (e.g., employed, unemployed, student) will be collected at baseline.'}, {'measure': 'Prior Meditation Experience', 'timeFrame': 'At baseline', 'description': 'Participants will report whether they have prior meditation experience (yes/no) and, if applicable, the number of months or years of practice.Additionally, they will indicate the type of meditation practice previously performed (e.g., mindfulness, compassion, other).'}, {'measure': 'Number of Meditation Session', 'timeFrame': 'During the 8-week intervention', 'description': 'Participants will indicate the sequential number of each formal meditation session completed during the 8-week intervention (e.g., Session 1, Session 2, Session 3).'}, {'measure': 'Perceived Quality of Meditation Practice', 'timeFrame': 'During the 8-week intervention', 'description': 'After each formal meditation session, participants will rate the perceived quality of their practice on a scale from 0 (very poor) to 10 (excellent).'}, {'measure': 'Self-reported Affective State after Practice', 'timeFrame': 'During the 8-week intervention', 'description': 'Participants will rate their affective state immediately after each formal meditation session on a scale from 0 (very negative) to 10 (very positive).'}, {'measure': 'Qualitative phenomenological exploration', 'timeFrame': 'From baseline to post-intervention (8 weeks after baseline)', 'description': "Semi-structured micro-phenomenological interviews will be conducted at baseline and immediately after the 8-week intervention to explore participants' lived experience related to self-perception, embodiment, and contemplative transformation. These data are exploratory and will not be included in inferential statistical analyses."}], 'primaryOutcomes': [{'measure': 'Delusion of Me Index (DoM)', 'timeFrame': 'From baseline to 6-month follow-up', 'description': '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.'}, {'measure': 'Nondual Awareness Dimensional Assessment (NADA)', 'timeFrame': 'From baseline to 6-month follow-up', 'description': '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.'}, {'measure': 'Body Appreciation Scale-2 (BAS-2)', 'timeFrame': 'From baseline to 6-month follow-up', 'description': '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.'}, {'measure': 'Body Shape Questionnaire-10 (BSQ-10)', 'timeFrame': 'From baseline to 6-month follow-up', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Pemberton Happiness Index (PHI)', 'timeFrame': 'From baseline to 6-month follow-up', 'description': 'Change in Psychological Well- Being'}, {'measure': 'SOCS-S Sussex-Oxford Self- Compassion Scale', 'timeFrame': 'From baseline to 6-month follow-up', 'description': 'Change in Self - Compassion'}, {'measure': 'Five Facet Mindfulness Questionnaire (FFMQ).', 'timeFrame': 'From baseline to 6-month follow-up', 'description': 'Change in Mindfulness'}, {'measure': 'Body Image Acceptance and Action Questionnaire (BI-AAQ-5).', 'timeFrame': 'From baseline to 6-month follow-up', 'description': 'Change in Body Acceptance'}, {'measure': 'Sussex- Oxford Compassion Scale (SOCS - O)', 'timeFrame': 'From baseline to 6-month follow-up', 'description': 'Change in Compassion (for others)'}, {'measure': 'Multidimensional Assessment of Interoceptive Awareness (MAIA)', 'timeFrame': 'From baseline to 6-month follow-up', 'description': 'Change in Interoceptive Awareness'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Mental Health', 'Self Concept', 'Body Dissatisfaction', 'Compassion', 'Self-Perception', 'Mindfulness Meditation', 'Meditation', 'Psychological Well-being']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.\n\nVariables 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.\n\nStatistical 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Sex assigned female at birth and self-identifies as a woman\n* Aged between 30 and 60 years\n* Spanish nationality, or residency in Spain for more than 5 years\n* Fluent in Spanish\n* At least one month of experience with meditation or mindfulness practices, with a regular practice of more than 15 minutes per session\n* Provides informed consent\n\nExclusion Criteria:\n\n* Indicators of eating disorders (ED) or mental health deterioration, determined by the following cut-off points: SCOFF ≥ 2 and PHQ-9 ≥ 10\n* Formal diagnosis of an eating disorder or any psychiatric condition\n* Substance use disorder\n* History of neurological disease diagnosis\n* Participant's decision to withdraw from the study at any point"}, 'identificationModule': {'nctId': 'NCT06950905', 'briefTitle': 'Contemplative Practice for Well-being and Self-Deconstruction in Women', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Miguel Servet'}, 'officialTitle': 'Effectiveness of a Contemplative Practice on Psychological Well-Being, Self-Deconstruction, Body Image, Body Acceptance, and Compassion in Women', 'orgStudyIdInfo': {'id': 'PI25/008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Feeding Your Demons practice', 'description': 'The experimental group will engage in a "Feeding Your Demons" contemplative practice involving repeated sessions (30-60 minutes each).\n\nThe practice follows this structured protocol across sessions:\n\nPreparation: Preparation: Comfortable sitting posture in a chair, with an empty chair in front.\n\nTheme/Visualization: Identify a challenge (e.g., self-criticism, body dissatisfaction), observe bodily sensations, personify as a "demon" (note traits).\n\nDialogue: Shift chairs, embody the demon, answer: What do you want? Need? How will you feel when fulfilled?\n\nTransformation: Return, dissolve demon into "nectar" (embodying its need), feed until it becomes an ally.\n\nAlly Engagement: Note ally\'s traits, ask: How will you help/protect? What promise? How to access you? Briefly embody ally.\n\nClosure: Ally dissolves into participant; and both dissolves and rest in present-moment awareness.', 'interventionNames': ['Behavioral: Feeding your demons practice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness Meditation condition', 'description': '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:\n\nPreparation and Posture: Participants adopt a comfortable seated position with an upright spinal alignment.\n\nBreath Awareness: Sustained attention is directed toward natural respiratory rhythms without deliberate modulation.\n\nBody Scan: Systematic observation of somatic states (e.g., tension or relaxation) across distinct anatomical regions.\n\nObservation of Thoughts and Emotions: Transient cognitive and affective phenomena are acknowledged with non-judgmental detachment, avoiding engagement.\n\nClosure: Each session concludes with a return to breath-centered focus and gradual reorientation to the external environment.', 'interventionNames': ['Behavioral: Mindfulness practice']}], 'interventions': [{'name': 'Feeding your demons practice', 'type': 'BEHAVIORAL', 'otherNames': ['Feeding your demons', 'FYD'], 'description': '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.', 'armGroupLabels': ['Feeding Your Demons practice']}, {'name': 'Mindfulness practice', 'type': 'BEHAVIORAL', 'otherNames': ['Mindfulness', 'Mindfulness meditation', 'Attentional meditation'], 'description': '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.', 'armGroupLabels': ['Mindfulness Meditation condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50009', 'city': 'Zaragoza', 'state': 'Zaragoza', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier García Campayo', 'role': 'CONTACT', 'email': 'investigaprimaria@gmail.com', 'phone': '976 50 65 78'}, {'name': 'Javier García Campayo', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paulina Lamas Morales', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yolanda López del Hoyo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Psychiatry. Miguel Servet University Hospital', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '50009', 'city': 'Zaragoza', 'state': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier García Campayo, Doctor', 'role': 'CONTACT', 'email': 'investigacioncontemplativa@gmail.com', 'phone': '976761714'}, {'role': 'CONTACT', 'email': 'investigacioncontemplativa@gmail.com'}], 'facility': 'University of Zaragoza', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Javier Garcia Campayo', 'role': 'CONTACT', 'email': 'investigaprimaria@gmail.com', 'phone': '976 50 65 78'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Miguel Servet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Javier Garcia Campayo', 'investigatorAffiliation': 'Hospital Miguel Servet'}}}}