Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 10:42 PM
Study NCT ID:
NCT06099561
Status:
RECRUITING
Last Update Posted:
2024-12-10
First Post:
2023-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intractable Self-harm-What Support is Effective?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)', 'timeFrame': 'Monthly from baseline to endpointat 24 months and at follow-up at 36 months.', 'description': 'Level of daily functioning and disability in the domains of cognition, mobility, self-care, getting along with other people and life activities.'}], 'secondaryOutcomes': [{'measure': 'Five Self-harm behaviour groupings measure (5S-HM)', 'timeFrame': 'Weekly from baseline to endpointat 24 months and at follow-up at 36 months.', 'description': 'Indirect and direct self-harming behaviour'}, {'measure': 'The 5-level EQ-5D', 'timeFrame': 'Monthly from baseline to endpointat 24 months and at follow-up at 36 months.', 'description': 'Quality of life scale'}, {'measure': 'Cost effectiveness', 'timeFrame': 'Monthly from baseline to endpointat 24 months and at follow-up at 36 months.', 'description': 'Quantities and costs related to healthcare, municipal, social and rescue services.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deliberate self-harm', 'Suicide'], 'conditions': ['Self-harm']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to evaluate a novel treatment program for individuals with intractable and lethal self-harm.\n\nThe main questions are:\n\n1: Is there, in individuals with intractable self-harm, a relevant improvement in daily functioning and is this improvement related to the provided interventions?\n\nThe secondary research questions are:\n\n2\\. Is there, in individuals with intractable self-harm, a relevant improvement in frequency and severity of self-harm?\n\n3\\. Is there, in individuals with intractable self-harm, a relevant improvement in voluntary hospital admissions?\n\n4\\. Is there, in individuals with intractable self-harm, a relevant improvement in compulsary hospital admissions?\n\n5\\. Is there, in individuals with intractable self-harm, a relevant improvement in the use of medication pro re nata?\n\n6\\. Is there, in individuals with intractable self-harm, a relevant improvement in cost-effectiveness related to the provided interventions?', 'detailedDescription': 'Individuals with intractable, imminent and lethal self-harm often have multifaceted psychiatric symptoms, pervasive suffering, high mortality and a reduced level of daily functioning. Severe self-harm can lead to long periods of psychiatric inpatient care which can lead to reduced autonomy and aggravated self-harm. Effects of this care remain uncertain. The Swedish National Board of Welfare has provided National specialized medical care units for severe self-harm behaviour to three Swedish hospitals.\n\nIn one of this hospitals, Region Skåne, the intervention will be consultation-based. Individuals with intractable self-harm will be offered an assessment and review of all medical records which will result in a individualized intervention plan. Interventions include further assessments and supporting the existing treatment providers, families or caregivers. Recurring network-meetings will occur every three months as well as at he end of the intervention.\n\nData collection will include self-report measures as well as information from charts and national och regional registries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A group of individuals with severe self-harm, commonly with comorbid psychiatric diagnoses and cognitive challanges.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having tried or made serious attempt to try at least two different interventions with evidence to reduce self-harm, without sufficient reduction in suffering or self-harm\n\nExclusion Criteria:\n\n* Need for translation services to complete measures or interviews\n* Not able to complete measures or interviews'}, 'identificationModule': {'nctId': 'NCT06099561', 'briefTitle': 'Intractable Self-harm-What Support is Effective?', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Svårbehandlat självskadebeteende-Vilka Insatser är Effektiva?', 'orgStudyIdInfo': {'id': 'Dnr 2023-01650-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Individuals with current severe, imminent and lethal self-harm with a history of at least two interventions without sufficient reduction of self-harm or suffering.', 'interventionNames': ['Behavioral: National specialized medical care unit for severe self-harm behaviour-Consultation model']}], 'interventions': [{'name': 'National specialized medical care unit for severe self-harm behaviour-Consultation model', 'type': 'BEHAVIORAL', 'description': 'Extensive assessments. Consultation and training for existing treatment providers and caregivers. Network-meetings for providers and caregivers.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22185', 'city': 'Lund', 'state': 'Skåne County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Magnus Nilsson, PhD', 'role': 'CONTACT', 'email': 'magnus.per.nilsson@skane.se', 'phone': '046-174925'}, {'name': 'Sofie Westling, MD/PhD', 'role': 'CONTACT', 'email': 'sofie.westling@skane.se'}, {'name': 'Magnus Nilsson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Highly Specialized Unit for Self-Harm Behaviours, Skåne', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'centralContacts': [{'name': 'Magnus Nilsson, PhD', 'role': 'CONTACT', 'email': 'magnus.per.nilsson@skane.se', 'phone': '046-174925'}, {'name': 'Sofie Westling, MD/PhD', 'role': 'CONTACT', 'email': 'sofie.westling@skane.se'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Possible ot applicable due to Swedish data protection legislation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Psychology. Lund University.', 'class': 'UNKNOWN'}, {'name': 'Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}