Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00736918
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2008-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RCT of Post-Suicide Attempt Case Management (ACTION-J)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013406', 'term': 'Suicide, Attempted'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019090', 'term': 'Case Management'}], 'ancestors': [{'id': 'D010347', 'term': 'Patient Care Planning'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 914}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-14', 'studyFirstSubmitDate': '2008-08-15', 'studyFirstSubmitQcDate': '2008-08-15', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)', 'timeFrame': 'at 1 month after the randomization'}, {'measure': 'Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)', 'timeFrame': 'at 3 months after the randomization'}, {'measure': 'Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)', 'timeFrame': 'at 6 months after the randomization'}, {'measure': 'Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)', 'timeFrame': 'at 12 months after the randomization'}, {'measure': 'Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)', 'timeFrame': 'at 18 months after the randomization'}], 'primaryOutcomes': [{'measure': 'First recurrent suicide behavior (suicide attempted and completed suicide)', 'timeFrame': 'Minimum 1.5 year'}], 'secondaryOutcomes': [{'measure': 'Any cause of death', 'timeFrame': 'Minimum 1.5 year'}, {'measure': 'Repeated recurrent incidence of suicide attempts', 'timeFrame': 'Minimum 1.5 year'}, {'measure': 'Utilization or personal or social resources', 'timeFrame': 'Minimum 1.5 year'}, {'measure': 'Number of self-injury', 'timeFrame': 'Minimum 1.5 year'}, {'measure': 'Health care utilization', 'timeFrame': 'Minimum 1.5 year'}, {'measure': 'Physical function', 'timeFrame': 'Minimum 1.5 year'}, {'measure': 'Beck hopeless scale', 'timeFrame': 'Minimum 1.5 year'}, {'measure': 'SF-36', 'timeFrame': 'Minimum 1.5 year'}, {'measure': 'Adverse events', 'timeFrame': 'Minimum 1.5 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Suicide Attempt'], 'conditions': ['Suicide Attempt']}, 'referencesModule': {'references': [{'pmid': '19781096', 'type': 'BACKGROUND', 'citation': 'Hirayasu Y, Kawanishi C, Yonemoto N, Ishizuka N, Okubo Y, Sakai A, Kishimoto T, Miyaoka H, Otsuka K, Kamijo Y, Matsuoka Y, Aruga T. A randomized controlled multicenter trial of post-suicide attempt case management for the prevention of further attempts in Japan (ACTION-J). BMC Public Health. 2009 Sep 26;9:364. doi: 10.1186/1471-2458-9-364.'}, {'pmid': '18524048', 'type': 'BACKGROUND', 'citation': 'Kawanishi C, Hirayasu Y, Ariga T, Ishizuka N, Yamada M, Takahashi K. ["ACTION-J", a multi-center joint study for the development of strategies to prevent recurrence of suicidal ideation (a strategic study for anti-suicide policies supported by the Health, Labor and Welfare Ministry): its background and research outline]. Seishin Shinkeigaku Zasshi. 2008;110(3):230-7. No abstract available. Japanese.'}, {'pmid': '34332432', 'type': 'DERIVED', 'citation': 'Inui-Yukawa M, Miyaoka H, Yamamoto K, Kamijo Y, Takai M, Yonemoto N, Kawanishi C, Otsuka K, Tachikawa H, Hirayasu Y. Effectiveness of assertive case management for patients with suicidal intent. Psychiatry Res. 2021 Oct;304:114125. doi: 10.1016/j.psychres.2021.114125. Epub 2021 Jul 19.'}, {'pmid': '33884617', 'type': 'DERIVED', 'citation': 'Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.'}, {'pmid': '32368793', 'type': 'DERIVED', 'citation': 'Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.'}, {'pmid': '26360731', 'type': 'DERIVED', 'citation': 'Kawanishi C, Aruga T, Ishizuka N, Yonemoto N, Otsuka K, Kamijo Y, Okubo Y, Ikeshita K, Sakai A, Miyaoka H, Hitomi Y, Iwakuma A, Kinoshita T, Akiyoshi J, Horikawa N, Hirotsune H, Eto N, Iwata N, Kohno M, Iwanami A, Mimura M, Asada T, Hirayasu Y; ACTION-J Group. Assertive case management versus enhanced usual care for people with mental health problems who had attempted suicide and were admitted to hospital emergency departments in Japan (ACTION-J): a multicentre, randomised controlled trial. Lancet Psychiatry. 2014 Aug;1(3):193-201. doi: 10.1016/S2215-0366(14)70259-7. Epub 2014 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts', 'detailedDescription': 'It is well known that many subjects who survived a suicide attempt will make further suicide attempts, even after the medical treatment at critical emergency unit. To examine the effectiveness of continuous follow-up care by case manager after the suicide attempt, a randomized, controlled, multicenter trial by J-MISP (Japanese Multimodal Intervention Trials).This research project is one of the strategic research projects funded by The Japanese Ministry of Health, Labor and Welfare. In this study, J-MISP will implement the intervention for suicide attempters, a considerably high-risk group of further suicide attempts, who are transported by emergency services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over 20 years old\n2. Suffering from Axis I disorder\n3. Had intent for suicide (confirmed more than 2 times)\n4. Able to understand this study and provide informed consent\n5. Able to have interview before trial registry and psycho education at hospital\n6. Able to have interview for assessment at continuous follow-up care by case manager at the hospital\n\nExclusion Criteria:\n\n1. Not suffering from Axis I disorder as a primary diagnosis'}, 'identificationModule': {'nctId': 'NCT00736918', 'acronym': 'ACTION-J', 'briefTitle': 'RCT of Post-Suicide Attempt Case Management (ACTION-J)', 'organization': {'class': 'OTHER', 'fullName': 'Japan Foundation for Neuroscience and Mental Health'}, 'officialTitle': 'A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)', 'orgStudyIdInfo': {'id': 'J-MISP-01'}, 'secondaryIdInfos': [{'id': 'C000000444', 'type': 'REGISTRY', 'domain': 'UMIN-CTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Case management', 'description': 'Case management', 'interventionNames': ['Behavioral: Case management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced usual care', 'description': 'Enhanced usual care', 'interventionNames': ['Other: Enhanced usual care']}], 'interventions': [{'name': 'Case management', 'type': 'BEHAVIORAL', 'description': 'Case management, Usual clinical practice and Providing paper based information for suicide prevention', 'armGroupLabels': ['Case management']}, {'name': 'Enhanced usual care', 'type': 'OTHER', 'description': 'Usual clinical practice and Providing paper based information for suicide prevention', 'armGroupLabels': ['Enhanced usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '470-1192', 'city': 'Toyoake', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Fujita Health University Hospital', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'zip': '814-0128', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '311-3198', 'city': 'Mito', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'National Hospital Organization, Mito Medical Center', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'zip': '300-0053', 'city': 'Tsuchiura', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Tsuchiura Kyodo Hospital', 'geoPoint': {'lat': 36.09047, 'lon': 140.21047}}, {'zip': '305-8558', 'city': 'Tsukuba', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Tsukuba Medical Center', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'zip': '020-0023', 'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Iwate Medical University Hospital', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'zip': '228-0829', 'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kitazato University Hospital', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'zip': '232-0024', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokohama City University Medical Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '634-0813', 'city': 'Kashihara', 'state': 'Nara', 'country': 'Japan', 'facility': 'Nara Medical University Hospital', 'geoPoint': {'lat': 33.95, 'lon': 135.78333}}, {'zip': '874-8585', 'city': 'Beppu', 'state': 'Oita Prefecture', 'country': 'Japan', 'facility': 'Oita Kouseiren Tsurumi Hospital', 'geoPoint': {'lat': 33.27945, 'lon': 131.49751}}, {'zip': '897-5503', 'city': 'Yufu', 'state': 'Oita Prefecture', 'country': 'Japan', 'facility': 'Oita University Hospital', 'geoPoint': {'lat': 33.1956, 'lon': 131.37829}}, {'zip': '570-0074', 'city': 'Moriguchi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kansai Medical University Takii Hospital', 'geoPoint': {'lat': 34.73333, 'lon': 135.56667}}, {'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'National Hospital Organization, Osaka Medical Center', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '589-0014', 'city': 'Sayama', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kinki University Hospital', 'geoPoint': {'lat': 34.51685, 'lon': 135.56298}}, {'zip': '350-8550', 'city': 'Kawagoe', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University Medical Center', 'geoPoint': {'lat': 35.90861, 'lon': 139.48528}}, {'zip': '350-0495', 'city': 'MorohongÅ', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University Hospital', 'geoPoint': {'lat': 35.93556, 'lon': 139.30444}}, {'zip': '113-0022', 'city': 'Tokyo', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Nihon Medical University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '142-0064', 'city': 'Tokyo', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Showa University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Yoshio Hirayasu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yokohama City University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Japan Foundation for Neuroscience and Mental Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center of Neurology and Psychiatry, Japan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}