Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT00821756
Status:
UNKNOWN
Last Update Posted:
2009-01-13
First Post:
2009-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Amager Project: Intervention After Suicide Attempt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013406', 'term': 'Suicide, Attempted'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-12', 'studyFirstSubmitDate': '2009-01-12', 'studyFirstSubmitQcDate': '2009-01-12', 'lastUpdatePostDateStruct': {'date': '2009-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persons repeating a suicidal act', 'timeFrame': 'One, two and three years'}], 'secondaryOutcomes': [{'measure': 'Acts of suicidal behaviour Contacts with health system', 'timeFrame': 'One, two and three years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Suicidal behaviour', 'Attempted suicide', 'Self harm', 'Suicide', 'Health system contacts', 'Contacts with health system'], 'conditions': ['Suicidal Behaviour', 'Repetition of Suicidal Behaviour']}, 'referencesModule': {'references': [{'pmid': '19016074', 'type': 'BACKGROUND', 'citation': 'Hvid M, Wang AG. Preventing repetition of attempted suicide--I. Feasibility (acceptability, adherence, and effectiveness) of a Baerum-model like aftercare. Nord J Psychiatry. 2009;63(2):148-53. doi: 10.1080/08039480802423022.'}, {'pmid': '21171837', 'type': 'DERIVED', 'citation': 'Hvid M, Vangborg K, Sorensen HJ, Nielsen IK, Stenborg JM, Wang AG. Preventing repetition of attempted suicide--II. The Amager project, a randomized controlled trial. Nord J Psychiatry. 2011 Oct;65(5):292-8. doi: 10.3109/08039488.2010.544404. Epub 2010 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nRepetition rate after a suicide attempt and self harm is very high, about 12-30 percent. Studies, reviewed by Hawton, 1999 show a lack of evidence for psychosocial interventions. Compliance with aftercare is also often very poor.\n\nObjective:\n\nInspired by the Norwegian Baerum project, the aim is to study if active, assertive outreach, seeking contact, talking about problem solution, motivate to comply to other appointments, will reduce repetition of suicidal acts in the following years.\n\nMethods:\n\nThe design is a prospective randomized, controlled trial. The patients (immediately after a suicide attempt or deliberate self harm)) included are randomized to intervention or standard (treatment as usual), aiming at at least 60 persons in each arm. The intervention is carried out through research nurses with about 8 home visits, phone contact, phone messaging, e-mails.Included are persons 12 years of age and older, danish speaking without translator and without diagnoses of severe mental illness (schizophrenia, bipolar illness, mania and severe/psychotic depression) or severe dementia.\n\nResults:\n\nOutcome is measured by repetition of suicidal act (suicide attempt, self harm or completed suicide)as recorded in medical records and by the Danish Cause of Death Register. Repetition measured by persons and by acts throughout 1 year, 2 and 3 years periods. Additional outcome is number and character of health system contacts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suicide attempt and self harm\n\nExclusion Criteria:\n\n* Severe mental diagnosis (schizophrenia, psychosis, bipolar affective disorder, severe/psychotic depression, severe dementia)'}, 'identificationModule': {'nctId': 'NCT00821756', 'acronym': 'Amager', 'briefTitle': 'The Amager Project: Intervention After Suicide Attempt', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Amager Project. Intervention After Suicide Attempt: A Randomized Study.', 'orgStudyIdInfo': {'id': 'AH-2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Assertive intervention in OPAC-style: Outreach,problem solving,adherence,continuity', 'interventionNames': ['Behavioral: OPAC (Outreach, Problem solving, Adherence, Continuity)']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Control arm: Treatment as usual'}], 'interventions': [{'name': 'OPAC (Outreach, Problem solving, Adherence, Continuity)', 'type': 'BEHAVIORAL', 'description': 'Assertive outreach immediately after the suicide attempt with about 8 home visits plus contact by telephone, phone messages, e-mails. Duration of intervention 6 months.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2300', 'city': 'Copenhagen S', 'country': 'Denmark', 'facility': 'Psychiatric Centre Amager, Copenhagen University Hospital'}], 'overallOfficials': [{'name': 'August G. Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychiatric Centre Amager, Copenhagen University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Social Affairs, Denmark', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'August G. Wang', 'oldOrganization': 'Psychiatric Centre Amager, Copenhagen, Denmark'}}}}