Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-02 @ 8:40 PM
Study NCT ID:
NCT01598220
Status:
COMPLETED
Last Update Posted:
2012-05-18
First Post:
2012-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer Assisted Cognitive Remediation Program in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-17', 'studyFirstSubmitDate': '2012-04-03', 'studyFirstSubmitQcDate': '2012-05-11', 'lastUpdatePostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in neurocognitive outcomes', 'timeFrame': 'Change from Baseline in neurocognitive measures up to the end of intervention at 6 months', 'description': "Attention:Continuous Performance TestII(CPT II)d'índex, Psychomotor Speed:Symbol Digit Modalities Test (SDMT; Smith, 1973,2002). Phonemic fluency FAS test (Benton \\& Hamsher 1976, 1989).Working Memory: Subtest Letter-Number Sequencing (WAIS-III):Verbal Learning:California Verbal Learning Test (CVLT, Delis et al 2000)short- term and long-term free recall.Executive function: Wisconsing Card Sorting Test(WCST; R.Heaton computer version CV3) categories and perseverations, Stroop test ( Stroop Color and Word Test; Stroop,1935; Golden,1994) , Matrix Reasoning (Adult Intelligence Scale-III ;WAIS-III)."}], 'secondaryOutcomes': [{'measure': 'Change in functional outcomes', 'timeFrame': 'Change from Baseline in functional measures up to the end of intervention at 6 months', 'description': 'The Heinrichs -Carpenter Quality of life Scale.(QLS, Heinrichs,1982; Spanish version Rodríguez et al.1995).QLS are divided in four subscales socialactivity, interpersonal relations,instrumental role functioning,intrapsychic functioning,and use of objects and participation.The Rosenberg Self-Esteem Scale (RSES,Rosenbeg,1965) were used as a indicator of an attitude of being good enough on 10 items'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['schizophrenia', 'cognitive remediation therapy', 'cognition', 'quality of life'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '17470957', 'type': 'BACKGROUND', 'citation': 'Wykes T, Reeder C, Landau S, Everitt B, Knapp M, Patel A, Romeo R. Cognitive remediation therapy in schizophrenia: randomised controlled trial. Br J Psychiatry. 2007 May;190:421-7. doi: 10.1192/bjp.bp.106.026575.'}, {'pmid': '20380784', 'type': 'BACKGROUND', 'citation': 'Grynszpan O, Perbal S, Pelissolo A, Fossati P, Jouvent R, Dubal S, Perez-Diaz F. Efficacy and specificity of computer-assisted cognitive remediation in schizophrenia: a meta-analytical study. Psychol Med. 2011 Jan;41(1):163-73. doi: 10.1017/S0033291710000607. Epub 2010 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether computer-assisted cognitive remediation therapy is effective in the treatment of cognitive deficits in schizophrenia.', 'detailedDescription': "Schizophrenia can be considered a chronic illness that affects all aspects of daily life. Cognitive deficits seems to play a key role that interferes directly in the functional adaptation.\n\nCognitive remediation therapy (CRT) emerges as a psychological intervention that target cognitive impairment. But, the use of computerized or papel an pencil procedures for remediation cognitive deficits remains controversial. Nonetheless, computer tasks offer a number of advantages compared to those of paper and pencil. The most noteworthy advantages are to enhance patient's motivation just because the sensory variety that the exercises presented or the possibility to provide immediate feedback. Furthermore, the possibility to present custom-tailored and adapted tasks taking into accounts the patients deficits and their evolution in the process of the psychological therapy is another important feature of computer-assisted cognitive remediation therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV (APA, 1994)criteria for schizophrenia disorder\n* Estimated IQ of 85 or superior by Vocabulary subtest, Wechsler Adult Intelligence Scale-III (WAIS-III)\n* Patients were considered sufficiently stable if they had a Global Assessment of Functioning Scale (GAF)score of 40 or superior and they maintained a stable dose and type of psychiatric medication for at least 1 moth prior to inclusion.\n\nExclusion Criteria:\n\n* Non presence of cognitive impairment confirmed by neurocognitive assessment\n* Traumatic brain injury or history of neurologic illness.\n* Electroconvulsive therapy in the last year.\n* Psychiatric comorbidity.\n* Plan to change medication during the trial.'}, 'identificationModule': {'nctId': 'NCT01598220', 'acronym': 'CACREPS', 'briefTitle': 'Computer Assisted Cognitive Remediation Program in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari de Terrassa'}, 'officialTitle': 'Efficacy Study of a Computer Cognitive Remediation Program in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'CACR-2012-MT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Computer-assisted cognitive remediation therapy', 'interventionNames': ['Behavioral: Computer-assisted cognitive remediation therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'attentional task', 'interventionNames': ['Other: attentional task']}], 'interventions': [{'name': 'Computer-assisted cognitive remediation therapy', 'type': 'BEHAVIORAL', 'otherNames': ['cognitive remediation therapy'], 'description': 'Comparison of two groups:\n\nThe experimental group performs 48 sessions of computer exercices designed to remedy cognitive domains(attention, speed of processing, working memory,reasoning and problem solving) frequently affected in schizophrenia.\n\nThe intervention has a period 6 months , two sessions a week. All exercises provided a visual or verbal feedback to immediately terminate the execution.In addition to, the therapist after the sessions interactively explain the results and the strategies employed by the patient.', 'armGroupLabels': ['Computer-assisted cognitive remediation therapy']}, {'name': 'attentional task', 'type': 'OTHER', 'description': 'The Control group performs 48 sessions of watching videos and answer questions about these videos, in a period of 6 months , two sessions a week.', 'armGroupLabels': ['attentional task']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08227', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'overallOfficials': [{'name': 'Gemma Garrido Garcia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consorci Sanitari de Terrassa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gemma Garrido García', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Efficacy study of a computer cognitive remediation program in patients with schizophrenia', 'investigatorFullName': 'Gemma Garrido García', 'investigatorAffiliation': 'Consorci Sanitari de Terrassa'}}}}