Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-28 @ 8:33 PM
Study NCT ID:
NCT02098408
Status:
COMPLETED
Last Update Posted:
2019-09-16
First Post:
2014-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072466', 'term': 'Cognitive Remediation'}, {'id': 'D015610', 'term': 'Serum Bactericidal Test'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D008826', 'term': 'Microbial Sensitivity Tests'}, {'id': 'D008828', 'term': 'Microbiological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004353', 'term': 'Drug Evaluation, Preclinical'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-13', 'studyFirstSubmitDate': '2014-03-18', 'studyFirstSubmitQcDate': '2014-03-24', 'lastUpdatePostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Schizophrenia Prediction/Proneness Instrument - Adult Version (SPI-A)', 'timeFrame': '6 and 12 months'}, {'measure': 'Behaviour Rating Inventory of Executive Function -Adult Version (BRIEF-A)', 'timeFrame': '6 and 12 months'}, {'measure': 'Global Functioning: Social and Role Scales', 'timeFrame': '6 and 12 months'}, {'measure': 'Quality Of Life Scale (QOLS).', 'timeFrame': '6 and 12 months'}, {'measure': 'Comprehensive Assessment of At-Risk Mental States (CAARMS)', 'timeFrame': '6 and 12 months'}, {'measure': 'The Awareness of Social Inference Test (TASIT)', 'timeFrame': '6 and 12 months'}, {'measure': 'Emotion Recognition Task (ERT)', 'timeFrame': '6 and 12 months', 'description': 'Emotion Recognition Task from CANTAB'}, {'measure': 'Social Responsiveness Scale (SRS)', 'timeFrame': '6 and 12 months'}, {'measure': 'Social Cognition Screening Questionnaire (SCSQ)', 'timeFrame': '6 and 12 months'}, {'measure': 'Adverse events', 'timeFrame': '6 and 12 months', 'description': 'Number of participants with adverse events'}, {'measure': 'The High-Risk Social Challenge (HiSoC) Task', 'timeFrame': '6 and 12 months'}], 'primaryOutcomes': [{'measure': 'Brief Assessment of Cognition in Schizophrenia (BACS)', 'timeFrame': '6 and 12 months', 'description': 'BACS will be used to assess changes in cognition at the cessation of treatment at (6 months) and 12 months post baseline.'}], 'secondaryOutcomes': [{'measure': 'Personal and Social Performance Scale (PSP)', 'timeFrame': '6 and 12 months'}, {'measure': 'Brief Psychiatric Rating Scale Expanded Version (BPRS-E)', 'timeFrame': '6 and 12 months'}, {'measure': 'Scale for the Assessment of Negative Symptoms (SANS)', 'timeFrame': '6 and 12 months'}, {'measure': 'The Montgomery-Åsberg Depression Rating Scale (MADRS)', 'timeFrame': '6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ultra-high risk psychosis', 'Schizophrenia prodrome', 'Cognitive remediation'], 'conditions': ['Patients at Ultra-high Risk of Psychosis']}, 'referencesModule': {'references': [{'pmid': '33005161', 'type': 'DERIVED', 'citation': 'Kristensen TD, Ebdrup BH, Hjorthoj C, Mandl RCW, Raghava JM, Jepsen JRM, Fagerlund B, Glenthoj LB, Wenneberg C, Krakauer K, Pantelis C, Glenthoj BY, Nordentoft M. No Effects of Cognitive Remediation on Cerebral White Matter in Individuals at Ultra-High Risk for Psychosis-A Randomized Clinical Trial. Front Psychiatry. 2020 Aug 28;11:873. doi: 10.3389/fpsyt.2020.00873. eCollection 2020.'}, {'pmid': '32873460', 'type': 'DERIVED', 'citation': 'Glenthoj LB, Mariegaard LS, Fagerlund B, Jepsen JRM, Kristensen TD, Wenneberg C, Krakauer K, Medalia A, Roberts DL, Hjorthoj C, Nordentoft M. Cognitive remediation plus standard treatment versus standard treatment alone for individuals at ultra-high risk of developing psychosis: Results of the FOCUS randomised clinical trial. Schizophr Res. 2020 Oct;224:151-158. doi: 10.1016/j.schres.2020.08.016. Epub 2020 Aug 29.'}, {'pmid': '32008981', 'type': 'DERIVED', 'citation': 'Wenneberg C, Nordentoft M, Rostrup E, Glenthoj LB, Bojesen KB, Fagerlund B, Hjorthoj C, Krakauer K, Kristensen TD, Schwartz C, Edden RAE, Broberg BV, Glenthoj BY. Cerebral Glutamate and Gamma-Aminobutyric Acid Levels in Individuals at Ultra-high Risk for Psychosis and the Association With Clinical Symptoms and Cognition. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Jun;5(6):569-579. doi: 10.1016/j.bpsc.2019.12.005. Epub 2019 Dec 19.'}, {'pmid': '25623736', 'type': 'DERIVED', 'citation': 'Glenthoj LB, Fagerlund B, Randers L, Hjorthoj CR, Wenneberg C, Krakauer K, Vosgerau A, Gluud C, Medalia A, Roberts DL, Nordentoft M. The FOCUS trial: cognitive remediation plus standard treatment versus standard treatment for patients at ultra-high risk for psychosis: study protocol for a randomised controlled trial. Trials. 2015 Jan 27;16:25. doi: 10.1186/s13063-014-0542-8.'}]}, 'descriptionModule': {'briefSummary': 'Cognitive deficits are known to be a core feature of schizophrenia and seem to become manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive deficits are known to pose a critical barrier to functional recovery. Hence it is of vital importance to find intervention strategies that can alleviate these cognitive deficits and consequently improve daily functioning, and quality of life, as well as the prognosis for UHR-patients. The investigators will examine whether:\n\n* Cognitive remediation therapy will be superior to standard treatment in improving cognitive functioning in UHR- patients (null hypothesis: No difference between the two groups).\n* Cognitive remediation therapy will be superior to standard treatment in improving psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No difference between the two groups).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-40 yrs.\n* Fulfill criteria for being at Ultra-High Risk of psychosis (defined by one or more of the following):\n\n * Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in functioning, or sustained low functioning during the past year.\n * Attenuated Psychotic Symptoms (APS) Group: Individuals with sub-threshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year.\n * Brief Limited Intermittent Psychotic Symptoms Group (BLIPS): Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year.\n* Provided informed consent.\n\nExclusion Criteria:\n\n* Past history of a treated or untreated psychotic episode of one week's duration or longer\n* Psychiatric symptoms that are explained by a physical illness with psychotropic effect or acute intoxication (e.g., cannabis use).\n* Diagnosis of a serious developmental disorder, e.g,. Asperger's syndrome\n* Currently receiving treatment with metylphenidate.\n* Rejects providing informed consent."}, 'identificationModule': {'nctId': 'NCT02098408', 'acronym': 'FOCUS', 'briefTitle': 'Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Mental Health Services in the Capital Region, Denmark'}, 'officialTitle': 'A Randomised Clinical Trial Examining Cognitive Remediation Plus Standard Treatment Versus Standard Treatment in Participants at Ultra-High Risk of Psychosis. - Effect on Cognitive Functioning, Functional Outcome and Symptomatology.', 'orgStudyIdInfo': {'id': 'H-6-2013-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard treatment + cognitive remediation', 'description': 'The cognitive remediation therapy targets neurocognition as well as social cognition.', 'interventionNames': ['Behavioral: Cognitive remediation', 'Behavioral: Standard treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment', 'description': 'Patients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling', 'interventionNames': ['Behavioral: Standard treatment']}], 'interventions': [{'name': 'Cognitive remediation', 'type': 'BEHAVIORAL', 'otherNames': ['Neuropsychological & Educational Approach to Remediation (NEAR) using software from Scientific Brain Training Pro (SBT) and Posit Science.', 'Social Cognition and Interaction Training (SCIT)'], 'description': 'Neurocognition will be trained using the NEAR model (Medalia et al. 2003), whereas the training of social cognitive skills will be by use of the SCIT manual (Social Cognition and Interaction Training) developed by Roberts et al. 2014.\n\nThe intervention consists of 24 group sessions taking place once a week (two hours) and additional neurocognitive training at home. Furthermore, there will be a total of 12 individual sessions aiming at bridging the cognitive training to the everyday functioning of the patients.', 'armGroupLabels': ['Standard treatment + cognitive remediation']}, {'name': 'Standard treatment', 'type': 'BEHAVIORAL', 'description': 'Patients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling.', 'armGroupLabels': ['Standard treatment', 'Standard treatment + cognitive remediation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Mental Health Centre Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Merete Nordentoft, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mental Health Services in the Capital Region, Denmark'}, {'name': 'Louise B Glenthøj, MsC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mental Health Services in the Capital Region, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mental Health Services in the Capital Region, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS', 'class': 'UNKNOWN'}, {'name': 'Copenhagen Trial Unit, Center for Clinical Intervention Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}