Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02399020
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2015-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Cognition and Interaction Training for Adults With Psychotic Disorders: An Open Pilot Study in Finland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-23', 'studyFirstSubmitDate': '2015-03-23', 'studyFirstSubmitQcDate': '2015-03-23', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement in social cognitive ability', 'timeFrame': '11-24 weeks', 'description': 'improvement according to measures of facial emotion recognition, theory of mind, attributional bias and social cognitive accuracy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psychotic Disorder', 'Cognitive Function 1, Social']}, 'referencesModule': {'references': [{'pmid': '19272654', 'type': 'BACKGROUND', 'citation': 'Roberts DL, Penn DL. Social cognition and interaction training (SCIT) for outpatients with schizophrenia: a preliminary study. Psychiatry Res. 2009 Apr 30;166(2-3):141-7. doi: 10.1016/j.psychres.2008.02.007. Epub 2009 Mar 9.'}, {'pmid': '17412842', 'type': 'BACKGROUND', 'citation': 'Penn DL, Roberts DL, Combs D, Sterne A. Best practices: The development of the Social Cognition and Interaction Training program for schizophrenia spectrum disorders. Psychiatr Serv. 2007 Apr;58(4):449-51. doi: 10.1176/ps.2007.58.4.449.'}, {'pmid': '8315144', 'type': 'BACKGROUND', 'citation': 'Kerr SL, Neale JM. Emotion perception in schizophrenia: specific deficit or further evidence of generalized poor performance? J Abnorm Psychol. 1993 May;102(2):312-8. doi: 10.1037//0021-843x.102.2.312.'}, {'pmid': '8541250', 'type': 'BACKGROUND', 'citation': 'Corcoran R, Mercer G, Frith CD. Schizophrenia, symptomatology and social inference: investigating "theory of mind" in people with schizophrenia. Schizophr Res. 1995 Sep;17(1):5-13. doi: 10.1016/0920-9964(95)00024-g.'}, {'pmid': '17453895', 'type': 'BACKGROUND', 'citation': 'Combs DR, Penn DL, Wicher M, Waldheter E. The Ambiguous Intentions Hostility Questionnaire (AIHQ): a new measure for evaluating hostile social-cognitive biases in paranoia. Cogn Neuropsychiatry. 2007 Mar;12(2):128-43. doi: 10.1080/13546800600787854.'}]}, 'descriptionModule': {'briefSummary': '33 individuals with a psychotic disorder were given 22-24 sessions weekly or twice weekly of Social Cognition and Interaction Training (SCIT) and evaluated at the baseline and after the intervention. Main outcome was improvement in social cognition according to specific measures of facial emotion identification, Theory of Mind, attributional bias, social cognitive accuracy and metacognitive overconfidence.', 'detailedDescription': '33 clinically stable in- and outpatients with chart diagnoses of schizophrenia, schizoaffective disorder or unspecified nonorganic psychosis, aged 18-56 years, were given 22-24 weekly or twice weekly sessions of a manualized group treatment for improvement of social cognition, Social Cognition and Interaction Training (1,2). Main outcome was defined as improvement in social cognition according to specific measures of facial emotion identification, Theory of Mind, attributional bias, social cognitive accuracy and metacognitive overconfidence.Emotion perception was measured with the Facial Emotion Identification Task (FEIT) (3); Theory of Mind was measured with the Hinting Task (4) and attributional bias with the Ambiguous Intentions Hostility Questionnaire-Ambiguous Items (AIHQ-A) (5). In addition, broad-based social cognitive accuracy, attributional bias and metacognitive overconfidence was measured with the Social Cognition Screening Questionnaire. All the measures were evaluated at the baseline and immediately after the intervention. Changes in total scores for the FEIT and Hinting Task, and the three subscales of AIHQ-A and SCSQ were analysed separately using paired samples t-test in IBM SPSS Statistics version 21.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of schizophrenia, schizoaffective disorder or psychosis NOS\n* inpatients in longer-stay rehabilitation wards or outpatients in supported housing\n* stable clinical condition\n* written informed consent\n* problems in social relationships according to the clinical staff\n* standard medical treatment provided by the care facilities\n\nExclusion Criteria:\n\n* inadequate command of Finnish language\n* unstable clinical condition'}, 'identificationModule': {'nctId': 'NCT02399020', 'briefTitle': 'Social Cognition and Interaction Training for Adults With Psychotic Disorders: An Open Pilot Study in Finland', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Social Cognition and Interaction Training (SCIT) for Adults With Psychotic Disorder: An Open Pilot Study in Finland', 'orgStudyIdInfo': {'id': '169/13/03/03/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCIT group', 'description': 'Social Cognition and Interaction Training intervention group', 'interventionNames': ['Behavioral: Social Cognition and Interaction Training']}], 'interventions': [{'name': 'Social Cognition and Interaction Training', 'type': 'BEHAVIORAL', 'description': 'manualized group treatment providing training in facial emotion recognition, understanding the role of emotion in social situations, training with videoed vignettes to avoid jumping to conclusions in order to avoid attributional biases, tolerating ambiguity and distinguishing facts from guesses, skill consolidation and generalization to everyday life situations.', 'armGroupLabels': ['SCIT group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Aurora Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Leena Turpeinen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'City of Helsinki Department of Social Services and Health Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, {'name': 'City of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician, Jorvi Psychosis Clinic', 'investigatorFullName': 'Jorma Oksanen MD', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}