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Clinical Trials/NCT01036282
NCT01036282
Completed
Phase 4

Computerized Cognitive Skills Training in Severe Mental Illness

Nathan Kline Institute for Psychiatric Research1 site in 1 country448 target enrollmentFebruary 2003

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Nathan Kline Institute for Psychiatric Research
Enrollment
448
Locations
1
Primary Endpoint
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The study is designed to evaluate the effectiveness of computerized cognitive skills training for improving memory and problem-solving skills in inpatients with schizophrenia.

Detailed Description

Subjects are stable inpatients and outpatients with schizophrenia or schizoaffective disorder who are receiving atipsychotic medication at Manhattan Psychiatric Center. Patients receive baseline assessments (MCCB-MATRICS; Personal and Social Performance Scale, FEDT/FEIT and PANSS) and then are assigned to Cognitive Remediation (CRT) using the COGPACK program, patients are then randomly assigned to a social cognition program (Mind Reader Interactive Guide to Emotions) for a period of 12 weeks. Following 12 weeks of treatment in either CRT + Mind Reader or CRT alone, assessments are repeated by raters. Cognitive Remediation (CRT): CRT (COGPACK, Marker and Olbrich, 1998) consists of computerized practice tests for seven cognitive domains. There are 64 programs for testing and training, each with several variants for the domains of visuomotor skills, comprehension, reaction, vigilance, memory, language, and intellectual skills. Exercises in COGPACK can be edited and expanded. Patients attend 2 (45-minutes each) groups and 1 discussion group. Social Cognition Training: Mind Reader (Baron-Cohen et al, 2004) is an interactive computerized program of emotions and mental states. It is based on a taxonomic system of 412 emotions and mental states, grouped into 24 emotion groups, and six developmental levels (from age 4 to adulthood). The emotions and mental states are organized systematically, according to the emotion groups and developmental levels. Patients assigned to Mind Reader attend 1 group per week. Both the CRT and Mind Reader are administered in small groups of six to eight patients each.

Registry
clinicaltrials.gov
Start Date
February 2003
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jean-Pierre Lindenmayer

Director of Research

Nathan Kline Institute for Psychiatric Research

Eligibility Criteria

Inclusion Criteria

  • Age 18 and above;
  • In- and out-patients;
  • DSM-IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder with illness duration \>5 years;
  • Auditory and visual acuity adequate to complete cognitive tests;
  • Stable dose of oral atypical antipsychotic for at least 4 weeks;
  • Total PANSS score \> 60;
  • Good physical health determined by physical examination from medical chart review;
  • Capacity and willingness to give written informed consent.

Exclusion Criteria

  • Inability to read or speak English;
  • Documented disease of the central nervous system;
  • History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation);
  • Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematological conditions;
  • Patients diagnosed with substance dependence;
  • Currently participating in another experimental study.

Outcomes

Primary Outcomes

Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)

Time Frame: Week 0, and Week 12 (after completion of Cognitive Remediation)

Comprehensive battery of neuro-cognitive tests

Secondary Outcomes

  • Facial Emotional Discrimination Task (FEDT) and Facial Emotional Identification Task (FEIT)(Week 0, and Week 12 (after compeltion of Cognitive Remediation))
  • Personal and Social Performance Scale (PSP)(Week 0, and Week 12 after completion of Cognitive Remediation)
  • Positive and Negative Syndrome Scale (PANSS)(Week 0, Week 6 (Midpoint) and Week 12 after completion of Cognitive Remediation)

Study Sites (1)

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