Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT05830903
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2019-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2019-07-04', 'studyFirstSubmitQcDate': '2023-04-13', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical ratings of schizophrenia symptoms', 'timeFrame': '8 weeks', 'description': 'The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale completed by trained research staff. Scores for positive, negative, cognitive disorganization, emotional discomfort, and hostility/excitement symptoms were derived from factor-derived scoring published.\n\n\\* There are 30 different symptoms rated from 1 to 7 (total score of 210). Higher the score, worse the symptoms'}, {'measure': 'vocational skills', 'timeFrame': '8 weeks', 'description': 'Job interview role-play performance will be scored across nine domains: conveying oneself as a hard worker, sounding easy to work with, conveying that one behaves professionally, negotiation skills (requesting one day off), sharing things in a positive way, sounding honest, sounding interested in the position, comfort level, and establishing rapport'}, {'measure': 'global improvement', 'timeFrame': '8 weeks', 'description': 'Clinical Global Impression Improvement scale (CGI-I) rating scales are commonly used measures of symptom severity, treatment response and the efficacy in treatment studies of patients with mental disorders. It is a 7-point scale that require clinician to assess how much the patient\'s illness has improved or worsened relative to baseline. "1" meaning very much improved, "7" meaning very much worsen.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'Establish a novel vocational training program and test its validity in a pilot study.', 'detailedDescription': '40 schizophrenia patients will be recruited to join the virtual reality based vocational training program, the training effect will be compared by interview skills and problem solving before and after the training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders -5th version\n* Aged between 20 and 55 years.\n* Motivated to have a job.\n* Having a full-scale IQ \\> 70 on the Wechsler Adult Intelligence Scale-version IV.\n* Having a PANSS positive scale \\< 70, indicating a stable condition during the illness course.\n\nExclusion Criteria:\n\n* Comorbid with other major psychiatric disorders (i.e., bipolar disorders) or neurological diseases.\n* Substance abuse within one year.\n* Visual impairment and/or hearing impairment that would preclude participation in the VR-based training program.'}, 'identificationModule': {'nctId': 'NCT05830903', 'briefTitle': 'Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques', 'orgStudyIdInfo': {'id': '201904105RINB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild ED/NS', 'description': '10 patients with mild or none executive function impairment and mild or none negative symptoms.', 'interventionNames': ['Behavioral: VR-assisted occupational training']}, {'type': 'EXPERIMENTAL', 'label': 'Mild ED/Severe NS', 'description': '10 patients with mild or none executive function impairment and severe or moderate negative symptoms.', 'interventionNames': ['Behavioral: VR-assisted occupational training']}, {'type': 'EXPERIMENTAL', 'label': 'Severe ED/Mild NS', 'description': '10 patients with severe or moderate executive function impairment and mild or none negative symptoms.', 'interventionNames': ['Behavioral: VR-assisted occupational training']}, {'type': 'EXPERIMENTAL', 'label': 'Severe ED/NS', 'description': '10 patients with severe or moderate executive function impairment and severe or moderate negative symptoms.', 'interventionNames': ['Behavioral: VR-assisted occupational training']}], 'interventions': [{'name': 'VR-assisted occupational training', 'type': 'BEHAVIORAL', 'description': 'VR-assisted occupational training', 'armGroupLabels': ['Mild ED/NS', 'Mild ED/Severe NS', 'Severe ED/Mild NS', 'Severe ED/NS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yi Ling Chien, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'ylchien@hotmail.com', 'phone': '886-2-2312-3456', 'phoneExt': '66013'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yi Ling Chien', 'role': 'CONTACT', 'email': 'ylchien@hotmail.com', 'phone': '886-2-2312-3456', 'phoneExt': '66013'}], 'overallOfficials': [{'name': 'Yi Ling Chien', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}