Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-29 @ 12:32 PM
Study NCT ID:
NCT05866328
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2019-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online TP (Training Program) on SC (Social Cognition) for Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}, {'id': 'D010166', 'term': 'Palliative Care'}, {'id': 'D007296', 'term': 'Myo-Inositol-1-Phosphate Synthase'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D019753', 'term': 'Intramolecular Lyases'}, {'id': 'D007535', 'term': 'Isomerases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-18', 'size': 384902, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-29T06:48', 'hasProtocol': True}, {'date': '2019-12-18', 'size': 98992, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-03T13:31', 'hasProtocol': False}, {'date': '2019-12-18', 'size': 199997, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-03T13:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Experimental: ET and IPS Control: IPS'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cognitive rehabilitation with a cognitive training program'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2019-09-11', 'studyFirstSubmitQcDate': '2023-05-09', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ekman 60 Faces Test total score changes', 'timeFrame': 'At baseline and after 1 year treatment', 'description': 'Minimum 0 and maximum 60. Between 20-40 years average 51.43, cut-off point 45, below deficit. Between 40-60 years, average 51.20, cut-off point 43, below deficit.'}, {'measure': 'Hinting Task total score changes', 'timeFrame': 'At baseline and after 1 year treatment', 'description': 'Total 1 minimum 0 and maximum 20. Total 2 minimum 0 and maximum 10. Cut-off point 18, less deficit.'}, {'measure': 'Happé Strange Stories Test total score changes', 'timeFrame': 'At baseline and after 1 year treatment', 'description': 'Total control minimum 0 and maximum 16. Total theory of mind minimum 0 and maximum 16. Cut-off point 14, below the deficit.'}, {'measure': 'Faux Pas Recognition Test total score changes', 'timeFrame': 'At baseline and after 1 year treatment', 'description': 'FP stories and C questions, C stories and FP questions and C stories and C questions minimum 0 and maximum 20. FP stories and FP questions minimum 0 and maximum 60. Cut-off point without errors 54 and with errors 48, lower deficit scores.'}, {'measure': 'Ambiguous Intentions and Hostility Questionnaire total score changes', 'timeFrame': 'At baseline and after 1 year treatment', 'description': 'Hostility, anger, guilt and aggression minimum 1 and maximum 5. Intentionality minimum 1 and maximum 6. Calculate the mean.'}, {'measure': 'Movie for the Assessment of Social Cognition total score changes', 'timeFrame': 'At baseline and after 1 year treatment', 'description': 'Minimum 0 and maximum 42.'}, {'measure': 'Screening for Cognitive Impairment in Psychiatry (SCIP-S) total score changes', 'timeFrame': 'At baseline and after 1 year treatment', 'description': 'Minimum 1 and maximum 99, very low range 1-2.5 and low range 2.5-15. The deterioration depends on the scale.'}, {'measure': 'Positive and Negative Symptom Scale (PANSS) total score changes', 'timeFrame': 'At baseline and after 1 year treatment', 'description': 'Positive and negative subscales minimum 7 and maximum 49. General psychopathology subscale minimum 16 and maximum 112. Composite subscale minimum -42 and maximum +42. Categorize subtype positive \\>0 and negative \\<0.'}], 'secondaryOutcomes': [{'measure': 'Employment', 'timeFrame': 'Up to 12 months in 2021', 'description': 'Number of jobs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rehabilitation', 'schizophrenia', 'emotional adjustment', 'theory of mind'], 'conditions': ['Social Cognition']}, 'referencesModule': {'references': [{'pmid': '28740808', 'type': 'RESULT', 'citation': 'Vazquez-Campo M, Marono Y, Lahera G, Mateos R, Garcia-Caballero A. e-Motional Training(R): Pilot study on a novel online training program on social cognition for patients with schizophrenia. Schizophr Res Cogn. 2016 Mar 12;4:10-17. doi: 10.1016/j.scog.2015.11.007. eCollection 2016 Jun.'}, {'pmid': '29535646', 'type': 'RESULT', 'citation': 'Marono Souto Y, Vazquez Campo M, Diaz Llenderrozas F, Rodriguez Alvarez M, Mateos R, Garcia Caballero A. Randomized Clinical Trial with e-MotionalTraining(R) 1.0 for Social Cognition Rehabilitation in Schizophrenia. Front Psychiatry. 2018 Feb 26;9:40. doi: 10.3389/fpsyt.2018.00040. eCollection 2018.'}, {'pmid': '38025483', 'type': 'DERIVED', 'citation': 'Rodriguez Pulido F, Caballero Estebaranz N, Garcia Caballero AA, Gonzalez Davila E, Leon Palacin C, Hernandez Alvarez de Sotomayor MDC, Lopez Reig S, Vilchez de Leon PI. Social cognition and emotional rehabilitation in participants with schizofrenia. Front Psychiatry. 2023 Nov 8;14:1250933. doi: 10.3389/fpsyt.2023.1250933. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial. Sixty-five participants (83% with schizophrenia or bipolar disorder) were recruited from community mental health teams. Fifty-seven met criteria and agreed to participate in the study. The conditions of cognitive rehabilitation were assigned randomly with support employment CR + IPS (n = 28) and IPS alone (n = 29). Cogpack program was used. Two groups were followed at 8 and 12 months after the baseline.', 'detailedDescription': 'This work was developed in the island of Tenerife (Spain) within a public service specialised in labour integration of people with disabilities in which an IPS team was set up in 2005. The study was carried out in collaboration with the units of community mental health of the island. These units carry out the control of people with serious mental illnesses including pharmacological treatment and psychosocial programming. All research procedures were approved by the Medicine Committee of Canary Health Services.\n\nThe follow-up period for the data collection was set between 2013 and 2014. Employment specialists belong to a public institution specialized in work disability.Sixty-five participants but only 57 signed written informed consent and completed the baseline. Two groups were assigned randomly:one with support employment and cognitive rehabilitation the second group with IPS alone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants had to:\n\n1. comply with the state definitions of severe mental illness (SMI), which includes an ICD-10 (World Health Organization, 1992) diagnosis of F20- 29 (schizophrenia, schizotypal, delusional and other non-mood psychotic disorders) and F31-F32.3 (major mood affective disorders)\n2. have previous difficulties to maintain a job\n3. currently want a competitive job and\n4. accept the job search starts\n\nExclusion Criteria:\n\nPeople with no Severe mental illness and not want to participate'}, 'identificationModule': {'nctId': 'NCT05866328', 'acronym': 'TP;SC', 'briefTitle': 'Online TP (Training Program) on SC (Social Cognition) for Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of La Laguna'}, 'officialTitle': 'Online Training Program on Social Cognition for Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'ULaguna'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Experimental Group (e-Motional Training and Individual Placement and Support)', 'interventionNames': ['Other: Cognitive Rehabilitation and Individual Placement and Support']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control Group (Individual Placement and Support)'}], 'interventions': [{'name': 'Cognitive Rehabilitation and Individual Placement and Support', 'type': 'OTHER', 'otherNames': ['CR and IPS'], 'description': 'Cognitive Rehabilitation and Individual Placement and Support', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38205', 'city': 'San Cristóbal de La Laguna', 'state': 'Santa CRUZ DE Tenerife', 'country': 'Spain', 'facility': 'Francisco Rodriguez Pulido', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}], 'overallOfficials': [{'name': 'Francisco Rodriguez Pulido, PHD MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of La Laguna'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '2019-2020', 'ipdSharing': 'YES', 'description': 'Publicate the results in a International Journal', 'accessCriteria': 'International Journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of La Laguna', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Santiago de Compostela', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Francisco Pulido', 'investigatorAffiliation': 'University of La Laguna'}}}}