Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT01740167
Status:
UNKNOWN
Last Update Posted:
2012-12-04
First Post:
2012-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Promotion on Young Adults With High Risk Disability for Mental Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-30', 'studyFirstSubmitDate': '2012-11-28', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Chinese mandarin version of State-Trait Anxiety Inventory from Y', 'timeFrame': '3 months'}, {'measure': 'simple physical assessment', 'timeFrame': '3 months'}, {'measure': 'Personal Inventory', 'timeFrame': '3 months'}, {'measure': '3 months physical activity assessment', 'timeFrame': '3 months'}], 'primaryOutcomes': [{'measure': 'Chinese version of Health-Promotion Lifestyle Profile-Short', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Chinese version of Schizotypal Personality Questionnaire-Brief', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prodrome', 'mental illness', 'health promotion', 'lifestyle behavior'], 'conditions': ['Mental Health Wellness 1']}, 'descriptionModule': {'briefSummary': '1. The positive outcomes reported by participants in experimental group after two weeks of interventions will be significantly better than before interventions.\n2. The positive outcomes reported by participants in experimental group will be significantly better than those in control group after two weeks of providing prevention model interventions.\n3. The positive outcomes reported by participants in experimental group will be significantly better than those in control group after six months of providing prevention model interventions.', 'detailedDescription': 'Early finding for people with high mental risk plays the important role in mental health promotion. In literature, before specific psychotic symptoms appear, individuals may experience a period of nonspecific symptoms and growing functional impairment. Early interventions may alter the natural course of mental diseases and improve treatment outcomes. So that, the purpose of this study is to develop a screen and prevention mode for identifying young adults with high risk status of mental health disability. The psychosocial intervention strategies for emotional and cognitive support in prevention model based on health promotion theory will be used for this study. Participants in this experimental design study will be randomly assigned into experimental and control groups. Four scales and objective physical assessments are used for evaluating study outcomes. The pre- and post-test will be held before and one week after prevention interventions. In addition, follow-ups will be included for understanding long-term outcomes of the effectiveness of the screen prevention model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20-65 years, (Chinese version of Schizotypal Personality Questionnaire-Brief \\> 17 scores, or Chinese Mandarin State Trait Anxiety Inventory Y2 \\> 60 scores), and agree to participants.\n\nExclusion Criteria:\n\n* had been diagnosed as schizophrenia, bipolar disorders, and major depression.'}, 'identificationModule': {'nctId': 'NCT01740167', 'acronym': 'HPMI', 'briefTitle': 'Health Promotion on Young Adults With High Risk Disability for Mental Health', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Health Promotion on Young Adults With High Risk Disability for Mental Health: Development and Evaluation of the Screen Prevention Model', 'orgStudyIdInfo': {'id': 'NSC101-2511-S-039-003'}, 'secondaryIdInfos': [{'id': 'DMR101-IRB2-222', 'type': 'OTHER', 'domain': 'ChinaMUH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle program', 'description': 'health promotion lifestyle program : individual counseling, once a month, total 3 times.', 'interventionNames': ['Behavioral: health promotion lifestyle program']}], 'interventions': [{'name': 'health promotion lifestyle program', 'type': 'BEHAVIORAL', 'description': 'Individual counseling, once a month, total 3 times.', 'armGroupLabels': ['Lifestyle program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40402', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Wei-Fen Ma, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}