Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 4:11 AM
Study NCT ID:
NCT05708404
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2023-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outpatient Treatment of Severe and Enduring Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000855', 'term': 'Anorexia'}, {'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': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'How the treatment goals were met', 'timeFrame': 'At the end of treatment, an average of 15.4 months', 'description': "Whether or not the patients' individual treatment goals, defined at the beginning of treatment, had been met, partly met, or not met at the end of treatment."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anorexia nervosa', 'Severe and enduring anorexia nervosa', 'Treatment'], 'conditions': ['Anorexia']}, 'referencesModule': {'references': [{'pmid': '37674214', 'type': 'DERIVED', 'citation': 'Algars M, Oshukova S, Suokas J. A novel outpatient treatment model for patients with severe and enduring anorexia nervosa: an observational study of patient characteristics, treatment goals, and treatment course. J Eat Disord. 2023 Sep 6;11(1):150. doi: 10.1186/s40337-023-00877-x.'}]}, 'descriptionModule': {'briefSummary': 'Approximately 20-30 % of individuals with the eating disorder anorexia nervosa develop an enduring form of the illness. In this study a new treatment for patients with severe and enduring anorexia nervosa was described. The treatment is flexible and aims at enhancing quality of life. The participants consisted of all referrals resulting in an assessment or treatment period at the unit between May 2017 and May 2022. The study was a registry study. Information regarding patient characteristics, treatment goals, and the course of treatment was gathered from medical records.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult women with severe and enduring anorexia nervosa.', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age ≥ 18 years\n* A referral resulting in an assessment or treatment period at the unit for patients with severe and enduring anorexia nervosa at the HUS Helsinki University Hospital between May 2017 and May 2022.'}, 'identificationModule': {'nctId': 'NCT05708404', 'briefTitle': 'Outpatient Treatment of Severe and Enduring Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'A Novel Outpatient Treatment for Patients With Severe and Enduring Anorexia Nervosa: Patient Characteristics, Treatment Goals, and Course of Treatment.', 'orgStudyIdInfo': {'id': 'PISARAAVO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Outpatient treatment of severe and enduring anorexia nervosa', 'type': 'BEHAVIORAL', 'description': 'A novel outpatient treatment of severe and enduring anorexia nervosa, aiming at enhancing quality of life and minimizing harm'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029 HUS', 'city': 'Helsinki', 'state': 'PL 282', 'country': 'Finland', 'facility': 'HUS Syömishäiriöyksikkö', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Jaana Suokas, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HUS Helsinki Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D.', 'investigatorFullName': 'Monica Algars', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}