Computer Assisted Cognitive Remediation Program in Schizophrenia

Schizophrenia Clinical Trial

— CACREPS  

Official title:

Efficacy Study of a Computer Cognitive Remediation Program in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598220
• Other study ID #: CACR-2012-MT
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: May 17, 2012
• Start date: September 2002
• Est. completion date: December 2005

Study information

• Verified date: May 2012
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Computer-assisted cognitive remediation therapy
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.

Other:
• attentional task
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.

Locations

Country	Name	City	State
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Gemma Garrido García

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from Baseline in neurocognitive measures up to the end of intervention at 6 months	No
Secondary	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	Change from Baseline in functional measures up to the end of intervention at 6 months	No