Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT05042869
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2021-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of a Body Dissatisfaction Program in Eating Disorders Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-06', 'studyFirstSubmitDate': '2021-09-01', 'studyFirstSubmitQcDate': '2021-09-06', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the body dissatisfaction program', 'timeFrame': 'Day 1', 'description': 'Participation rate in group sessions'}], 'secondaryOutcomes': [{'measure': 'Acceptability of the body dissatisfaction program', 'timeFrame': 'day 1', 'description': 'Satisfaction survey'}, {'measure': 'Evolution of the eating disorder symptomatology', 'timeFrame': 'day 1', 'description': 'Eating disorder symptomatology assessed with the Eating Disorder Examination (EDE-Q). Higher scores on the global scale and'}, {'measure': 'Evolution of the eating disorder symptomatology', 'timeFrame': 'day 1', 'description': 'Eating disorder symptomatology assessed with the Eating Disorder Inventory (EDI-2). Higher scores on the global scale and subscales indicate more severe disorder.'}, {'measure': 'Evolution of the body dissatisfaction level', 'timeFrame': 'day 1', 'description': 'Level of body dissatisfaction assessed with EDE-Q body weight and shape concerns subscales. Higher scores indicate higher body dissatisfaction'}, {'measure': 'Quality of life evolution', 'timeFrame': 'day 1', 'description': 'Quality of life assessed with Eating Disorders Quality Of Life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychiatry', 'Acceptance and Commitment Therapy', 'Body dissatisfaction'], 'conditions': ['Eating Disorders']}, 'descriptionModule': {'briefSummary': "The cognitive model of Eating Disorders (ED) highlights dysfunctional cognitive patterns common to the different subtypes. Body dissatisfaction, which can be defined as the negative and subjective evaluation of one's body shape, i.e., negative thoughts and emotions concerning one's body image and the origin of pathological behaviours with the aim of modifying one's weight and body shape, thus appears to be a central transdiagnostic concept in the ED. It is, moreover, described as a major factor in the development, maintenance and relapse of the various types of ED.\n\nIt is suggested that Acceptance and Commitment Therapy (ACT) may be beneficial in treating body dissatisfaction insofar as body image inflexibility appears to influence the relationship between body image appraisal and coping strategies. ACT, which aims to develop psychological flexibility, appeared to us as a promising tool to manage body dissatisfaction in ED.\n\nThe investigators therefore aim to evaluate the feasibility and acceptability of a psychological management group for body dissatisfaction (9 or 10 weekly group session), based on ACT therapy, in patients suffering from an ED."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eating Disorders patients participating in a body dissatisfaction management program', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Women over 16 years\n* Eating disorder, according to DSM-5 criteria (all types of eating disorder are included: anorexia, bulimia, binge eating disorder, …)\n* Marked body dissatisfaction\n* BMI \\> 17.5 kg/m2\n\nExclusion criteria:\n\n* Refusal to participate\n* Current severe psychiatric condition other than an ED that may impair patients' ability to attend the group\n* Pregnant or breastfeeding women\n* Protection measure or deprivation of liberty by administrative decision"}, 'identificationModule': {'nctId': 'NCT05042869', 'briefTitle': 'Feasibility and Acceptability of a Body Dissatisfaction Program in Eating Disorders Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Preliminary Study Evaluating Feasibility and Acceptability of a Psychological Management Program Focused on Body Dissatisfaction in Eating Disorders. SABG : Secondary Alveolar Bone Grafting', 'orgStudyIdInfo': {'id': 'RECHMPL21_0551'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Sébastien Guillaume, MD.PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}