Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:21 AM
Study NCT ID:
NCT07350720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inpatient Care of Patients With Difficult to Treat Anorexia Nervosa - Factors Affecting Treatment Outcome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D000856', 'term': 'Anorexia Nervosa'}], '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-09', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': 'BMI will be calulated on a weekly basis throughout the inpatient treatment period, and baseline measures until end of treatment/discharge from inpatient unit at approximately 12 weeks will be used for analysis.', 'description': 'BMI is calculated using weight and height: weight (kg) / (height (m) x height (m))'}], 'secondaryOutcomes': [{'measure': 'Treatment satisfaction', 'timeFrame': 'CSQ-8 is collected at the end of treatment/at discharge from inpatient care at approximately 12 weeks as well at 1 year follow-up after discharge, in order to evaluate the treatment given.', 'description': 'Satisfaction with treatment will be measured using the Client Satisfaction Questionnaire (CSQ-8), which contains 8 items. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eating Disorders', 'Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': "The overall aim of the project is to investigate factors that may influence treatment outcomes in people with difficult-to-treat anorexia nervosa who are enrolled in inpatient care at the Region Skåne Eating Disorders Centre in Lund. Treatment expectations, sense of autonomy, and patient participation, will be investigated, as well as caregivers' attitudes towards, and experiences of working with, autonomy and patient participation in the inpatient setting. The research project is expected to contribute to increased knowledge about the treatment of difficult-to-treat anorexia nervosa, and what part patient participation and autonomy may play when treating severe eating disorders. The overall objectives of the research program are:\n\n1. To contribute to increased knowledge about factors that influence the treatment of people with difficult-to-treat anorexia nervosa\n2. To highlight the role of autonomy and patient participation in inpatient care of severe eating disorders\n3. To use the research results for clinical improvement work at Region Skåne Eating Disorders Center"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with anorexia nervosa admitted to inpatient care at Region Skåne Eating Disorders Center, a specialized psychiatric care unit for treatment of eating disorders.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anorexia Nervosa diagnosis (ICD F50.0)\n* Admitted to inpatient care at department 5 at Region Skåne Eating Disorders Center\n\nExclusion Criteria:\n\n* Confidential identity\n* Inability to read or write in Swedish or English\n* Condition or treatment that, according to the study team, makes participation in the study inappropriate'}, 'identificationModule': {'nctId': 'NCT07350720', 'briefTitle': 'Inpatient Care of Patients With Difficult to Treat Anorexia Nervosa - Factors Affecting Treatment Outcome.', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Inpatient Care of Patients With Difficult to Treat Eating Disorders - What Affects Treatment Outcome?', 'orgStudyIdInfo': {'id': '2024-07313-01'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Emelia Mellergård, PhD', 'role': 'CONTACT', 'email': 'emelia.mellergard@skane.se', 'phone': '+46709407381'}], 'overallOfficials': [{'name': 'Emelia Mellergård, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Skåne VO Vuxenpsykiatri Lund'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}