Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-25 @ 2:42 PM
Study NCT ID:
NCT01318850
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2011-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through Functional Magnetic Resonance Imaging
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': 'D000097813', 'term': 'Coping Skills'}], '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': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-19', 'studyFirstSubmitDate': '2011-03-18', 'studyFirstSubmitQcDate': '2011-03-18', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fMRI patterns of connectivity', 'timeFrame': 'Change from baseline in Fractional Anisotropy an Independent Component Analisys indexes at 16 weeks', 'description': 'Scores on Fractional Anisotropy (FA) index from the Diffusor Technique Images (DTI) and Tract Based Spatial Statistics (TBSS) analyses. Also, scores in the Independent Component Analysis (ICA).'}], 'secondaryOutcomes': [{'measure': 'Symptoms', 'timeFrame': 'Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores at time 16 weeks', 'description': 'Scores on Positive and Negative Syndromes Scale (PANSS)'}, {'measure': 'Social Functioning', 'timeFrame': 'Change from baseline in scores of Social Functioning Scale at time 16 weeks', 'description': 'Score on Social Functioning Scale (SFS)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['schizophrenia', 'cognitive remediation', 'fMRI'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '23452665', 'type': 'BACKGROUND', 'citation': 'Penades R, Pujol N, Catalan R, Massana G, Rametti G, Garcia-Rizo C, Bargallo N, Gasto C, Bernardo M, Junque C. Brain effects of cognitive remediation therapy in schizophrenia: a structural and functional neuroimaging study. Biol Psychiatry. 2013 May 15;73(10):1015-23. doi: 10.1016/j.biopsych.2013.01.017. Epub 2013 Feb 26.'}, {'pmid': '26777884', 'type': 'BACKGROUND', 'citation': 'Penades R, Pujol N, Catalan R, Masana G, Garcia-Rizo C, Bargallo N, Gonzalez-Rodriguez A, Vidal-Pineiro D, Bernardo M, Junque C. Cortical thickness in regions of frontal and temporal lobes is associated with responsiveness to cognitive remediation therapy in schizophrenia. Schizophr Res. 2016 Mar;171(1-3):110-6. doi: 10.1016/j.schres.2016.01.006. Epub 2016 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'Cognitive Remediation Therapy (CRT) can enhance cognitive performance in patients with schizophrenia improving clinical outcome. However, the neurobiological mechanism underlying cognitive improvement is not well understood. The aim of this study is to investigate functional connectivity patterns before and after the neurocognitive rehabilitation therapy, especially in fronto-temporal circuitry.', 'detailedDescription': 'A controlled randomized study will be carry out with three different groups: patients receiving cognitive rehabilitation treatment (CRT), patients receiving another psychological intervention of control and a healthy control group. A descriptive study of cases will be also carried out. The functional MRI (fRMI) techniques as well as voxel-based morphometry allow individual analysis of cases.\n\nThe independent variable is the cognitive rehabilitation treatment. The CRT will be applied according to the manual of Wykes \\& Reeder (2005) Cognitive Remediation Therapy: Theory and Practice, Ed: Routledge. The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding (to provide strategies when the patient cannot carry out the task and to withdraw him when he is yet able of doing it alone) in a context of learning without errors.\n\nThe main dependent variable is the functional connectivity cerebral pattern obtained by means of functional magnetic resonance. Other secondary dependent variables are neurocognitive functioning, the symptomatic pattern and the psychosocial functioning obtained from the psychometric evaluation.\n\nAll the participants will be evaluated before and after the experimental intervention in neurocognitive areas (Battery will be composed by WAIS-III, RAVLT, Trail Making Test, STROOP color word, WCST, FAS-COWAT), symptomatic area (PANSS) and in social functioning (Social Functioning Scale SFS; Birchwood et al. 1990). The evaluations will be carried out by expert evaluators that will be blind to the experimental distribution. The statistics results analysis will be carry out by means of the statistical package SPSS 15.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia according to DSM-IV-TR and confirmed by the semi-structured interview (SCID) for the axis 1.\n* Presence of cognitive deficit confirmed by the neuropsychological battery.\n* Stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment.\n\nExclusion Criteria:\n\n* Presence of organic-cerebral affectation due to neurological or traumatic conditions\n* Abuse of psychotropic substances\n* Presence of other psychiatric symptomatology'}, 'identificationModule': {'nctId': 'NCT01318850', 'briefTitle': 'Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through Functional Magnetic Resonance Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Analysis of the Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through fMRI Techniques', 'orgStudyIdInfo': {'id': 'PI070258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Remediation Therapy', 'description': 'Cognitive Remediation Therapy -Frontal/Executive Program (Delahunty)- (Wykes and Reeder, 2005)', 'interventionNames': ['Behavioral: Cognitive Remediation Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psychoeducation', 'description': 'Symptom Management Module from the University of California. Liberman \\& Kopelowicz (1995)', 'interventionNames': ['Behavioral: Psychoeducation']}, {'type': 'OTHER', 'label': 'Healthy Controls', 'description': 'Healthy controls', 'interventionNames': ['Other: Healthy controls']}], 'interventions': [{'name': 'Cognitive Remediation Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive training, cognitive enhancement'], 'description': 'The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding (to provide strategies when the patient cannot carry out the task and to withdraw him when he is yet able of doing it alone) in a context of learning without errors.', 'armGroupLabels': ['Cognitive Remediation Therapy']}, {'name': 'Psychoeducation', 'type': 'BEHAVIORAL', 'otherNames': ['Coping strategies'], 'description': 'The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes teaching information and coping skills and neuropsychological issues are not addressed.', 'armGroupLabels': ['Psychoeducation']}, {'name': 'Healthy controls', 'type': 'OTHER', 'otherNames': ['No intervention'], 'description': 'No intervention', 'armGroupLabels': ['Healthy Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Rafael Penadés, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Barcelona', 'class': 'OTHER'}, {'name': 'Centro de Investigación Biomédica en Red de Salud Mental', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D.', 'investigatorFullName': 'Rafael Penades', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}