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Completed

NCT Number: NCT01598220

Computer Assisted Cognitive Remediation Program in Schizophrenia

The purpose of this study is to determine whether computer-assisted cognitive remediation therapy is effective in the treatment of cognitive deficits in schizophrenia.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computer-assisted cognitive remediation therapy

Behavioral

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 names: cognitive remediation therapy

attentional task

Other

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 outcomes

  1. Change in neurocognitive outcomes

    Time frame: Change from Baseline in neurocognitive measures up to the end of intervention at 6 months

    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 outcomes

  1. Change in functional outcomes

    Time frame: Change from Baseline in functional measures up to the end of intervention at 6 months

    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

Sponsors and collaborators

Lead sponsor

Gemma Garrido García

Other

Registry information

Official study title

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

Acronym: CACREPS

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
May 15, 2012
Registry last updated
May 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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