Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-13 @ 11:05 PM
Study NCT ID:
NCT02096432
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2014-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suicide Prevention in Chinese Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-03-21', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': "Outcome measure will be measured in 10 weeks' time"}]}, 'conditionsModule': {'conditions': ['Suicidal Ideation']}, 'descriptionModule': {'briefSummary': 'This project aims to develop and refine a suicide intervention protocol, and pilot test a culturally tailored randomized control trial to reduce suicidal thoughts among U.S. Chinese older adults. During the first phase of the study, the investigators plan to invite the community advisory board and key stakeholders to participate in the iterative design and refinement of the study protocol. During the second phase of the project and after the initial screening and based on a specific set of inclusion criteria, the investigators will invite U.S. Chinese older adult to participate in a pilot randomized control trial of a culturally adapted intervention to reduce the frequency and intensity of suicidal thoughts in Chinese older adults. During the third phase of the project, the investigators plan to invite pilot intervention participants as well as key stakeholders and health care professionals on the cultural acceptability of the pilot intervention. Through the achievement of these objectives, the investigators will set the foundation to fully test a culturally adapted in-home intervention, which may be particularly suitable for Chinese older adults with suicidal thoughts as it addresses cultural-specific barriers and integrates care management within existing community services agencies using non-mental health professionals, including community health workers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Self-identified as Chinese\n2. \\>50 years of age\n3. Suicidal thoughts within the last month as detected from the Item 9 in PHQ-9\n4. No plans to move for 6 months\n5. No significant cognitive impairment with Chinese Mini-Mental State Examination (C-MMSE) score \\>20'}, 'identificationModule': {'nctId': 'NCT02096432', 'briefTitle': 'Suicide Prevention in Chinese Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Suicide Prevention in Chinese Older Adults', 'orgStudyIdInfo': {'id': '13110601'}, 'secondaryIdInfos': [{'id': 'R34MH100443', 'link': 'https://reporter.nih.gov/quickSearch/R34MH100443', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral: Behavioral Activation', 'description': 'Behavioral Activation includes the following components: empowering education, referral to treatment, care Management, and behavior activation', 'interventionNames': ['Behavioral: Behavior Activation']}, {'type': 'OTHER', 'label': 'Usual Community Care', 'description': 'Community standard care as usual', 'interventionNames': ['Behavioral: Usual Community Care']}], 'interventions': [{'name': 'Behavior Activation', 'type': 'BEHAVIORAL', 'description': 'Behavioral Activation includes the following components: empowering education, referral to treatment, care Management, and behavior activation', 'armGroupLabels': ['Behavioral: Behavioral Activation']}, {'name': 'Usual Community Care', 'type': 'BEHAVIORAL', 'description': 'Community standard care as usual', 'armGroupLabels': ['Usual Community Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chinese community', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'XinQi Dong, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}, {'name': 'Melissa A. Simon, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}