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Completed

NCT Number: NCT01036282

Cognitive Skills Training Using Computer for Patients With Severe Mental Illness

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Manhattan Psychiatric Center

New York, 10605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.
  • MMSE > 24

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;
  • HIV +;
  • Patients diagnosed with substance dependence;
  • Currently participating in another experimental study.

Treatment and study plan

Computerized Cognitive Skill Training

Behavioral

Behavioral: Cognitive Remediation 45 mins 2 times per week sessions of cognitive remediation (COGPACK) over twelve weeks.

Other names: Cognitive Remediation Therapy

CRT and Social Cognition

Behavioral

Mind Reading, The Interactive Guide to Emotions for one 45 minute session per week for 12 weeks.

Other names: Social Emotional Functioning

Primary outcomes

  1. 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

  1. Facial Emotional Discrimination Task (FEDT) and Facial Emotional Identification Task (FEIT)

    Time frame: Week 0, and Week 12 (after compeltion of Cognitive Remediation)

    Test of facial emotion presentations on pictures to patients

  2. Personal and Social Performance Scale (PSP)

    Time frame: Week 0, and Week 12 after completion of Cognitive Remediation

    Social function scale with four sub domains of social functioning

  3. Positive and Negative Syndrome Scale (PANSS)

    Time frame: Week 0, Week 6 (Midpoint) and Week 12 after completion of Cognitive Remediation

    30 item Gold standard for measurement of psychiatric symptoms

Sponsors and collaborators

Lead sponsor

Nathan Kline Institute for Psychiatric Research

Other

Collaborators

  • Manhattan Psychiatric Center

Registry information

Official study title

Computerized Cognitive Skills Training in Severe Mental Illness

Important dates

Study start
2003
Primary completion
2016
Study completion
2016
First posted
Dec 21, 2009
Registry last updated
Jul 21, 2017

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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