Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT00400933
Status:
TERMINATED
Last Update Posted:
2012-02-13
First Post:
2006-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Six-session Psycho-education Group Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}], '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'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'shortage of experienced health care personnel after reorganisation of units', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-09', 'studyFirstSubmitDate': '2006-11-16', 'studyFirstSubmitQcDate': '2006-11-16', 'lastUpdatePostDateStruct': {'date': '2012-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scores on perceived caregiver burden (Experience of Caregiving Inventory [ECI])', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Scores on general health and relational variables', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psycho-education', 'Eating disorders', 'Personality disorders', 'Relatives and close friends', 'Caregiver burden'], 'conditions': ['Eating Disorders', 'Personality Disorders']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to analyze the impact of a psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders.', 'detailedDescription': 'The aim of this project is to analyze the impact of a six session psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders.\n\nMeasurements: General health, perceived caregiver burden, and relation to the patient at the following point of time: pre -, post- and follow up, with waiting list control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relatives and close friends to persons receiving treatment for their eating disorder and comorbid personality disorder.\n* \\> 18 years,\n* Speak and understand norwegian language, and\n* Informed consent to participate for both relative and patient.'}, 'identificationModule': {'nctId': 'NCT00400933', 'briefTitle': 'Evaluation of a Six-session Psycho-education Group Program', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Evaluation of a Six-session Psycho-education Group Program Delivered to Family Members and Close Friends of Patients Suffering From Eating Disorders and Co-morbid Personality Disorders', 'orgStudyIdInfo': {'id': '4,2006.2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'psycho-education', 'description': 'six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders', 'interventionNames': ['Behavioral: psycho-education']}], 'interventions': [{'name': 'psycho-education', 'type': 'BEHAVIORAL', 'description': 'six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders', 'armGroupLabels': ['psycho-education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7044', 'city': 'Trondheim', 'state': 'Trondheim', 'country': 'Norway', 'facility': 'Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Are Holen, PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Royal Norwegian Ministry of Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}