Computer Assisted Cognitive Remediation Program in Schizophrenia (CACREPS)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Computer-assisted cognitive remediation therapy
attentional task
Sponsored by

About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, cognitive remediation therapy, cognition, quality of life
Eligibility Criteria
Inclusion Criteria:
- DSM-IV (APA, 1994)criteria for schizophrenia disorder
- Estimated IQ of 85 or superior by Vocabulary subtest, Wechsler Adult Intelligence Scale-III (WAIS-III)
- 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.
Exclusion Criteria:
- Non presence of cognitive impairment confirmed by neurocognitive assessment
- Traumatic brain injury or history of neurologic illness.
- Electroconvulsive therapy in the last year.
- Psychiatric comorbidity.
- Plan to change medication during the trial.
Sites / Locations
- Consorci Sanitari de Terrassa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Computer-assisted cognitive remediation therapy
attentional task
Arm Description
Outcomes
Primary Outcome Measures
Change in neurocognitive outcomes
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).
Secondary Outcome Measures
Change in functional outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01598220
Brief Title
Computer Assisted Cognitive Remediation Program in Schizophrenia
Acronym
CACREPS
Official Title
Efficacy Study of a Computer Cognitive Remediation Program in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gemma Garrido García
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether computer-assisted cognitive remediation therapy is effective in the treatment of cognitive deficits in schizophrenia.
Detailed Description
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.
Cognitive 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, cognitive remediation therapy, cognition, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computer-assisted cognitive remediation therapy
Arm Type
Experimental
Arm Title
attentional task
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Computer-assisted cognitive remediation therapy
Other Intervention Name(s)
cognitive remediation therapy
Intervention Description
Comparison of two groups:
The 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.
The 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.
Intervention Type
Other
Intervention Name(s)
attentional task
Intervention 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.
Primary Outcome Measure Information:
Title
Change in neurocognitive outcomes
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).
Time Frame
Change from Baseline in neurocognitive measures up to the end of intervention at 6 months
Secondary Outcome Measure Information:
Title
Change in functional outcomes
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
Time Frame
Change from Baseline in functional measures up to the end of intervention at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV (APA, 1994)criteria for schizophrenia disorder
Estimated IQ of 85 or superior by Vocabulary subtest, Wechsler Adult Intelligence Scale-III (WAIS-III)
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.
Exclusion Criteria:
Non presence of cognitive impairment confirmed by neurocognitive assessment
Traumatic brain injury or history of neurologic illness.
Electroconvulsive therapy in the last year.
Psychiatric comorbidity.
Plan to change medication during the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gemma Garrido Garcia
Organizational Affiliation
Consorci Sanitari de Terrassa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Consorci Sanitari de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08227
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
17470957
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.
Results Reference
background
PubMed Identifier
20380784
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.
Results Reference
background
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Computer Assisted Cognitive Remediation Program in Schizophrenia
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