Cognitive Skills Training Using Computer for Patients With Severe Mental Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01036282
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : July 21, 2017
Manhattan Psychiatric Center
Information provided by (Responsible Party):
Jean-Pierre Lindenmayer, Nathan Kline Institute for Psychiatric Research

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Behavioral: Computerized Cognitive Skill Training Behavioral: CRT and Social Cognition Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arm, parallel group, randomized, blinded 12 -week intervention study of two forms of cognitive remediation in patients with chronic schizophrenia
Masking: Single (Outcomes Assessor)
Masking Description: Raters were blind to the type of interventions
Primary Purpose: Treatment
Official Title: Computerized Cognitive Skills Training in Severe Mental Illness
Actual Study Start Date : February 2003
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Computerized Cognitive Remediation
Two arms: 1. Computerized Cognitive Remediation treatment using COGPACK. and 2. PositScience. Each arm is further randomized to either MindReader or no Mindreader.(Social Cognition Training).
Behavioral: Computerized Cognitive Skill Training
Behavioral: Cognitive Remediation 45 mins 2 times per week sessions of cognitive remediation (COGPACK) over twelve weeks.
Other Name: Cognitive Remediation Therapy

Experimental: CRT + Social Cognition Training
Two 45-minute sessions of Computerized Cognitive Remediation using COGPACK, one 45-minute discussion session, plus one 45 minute Mind Reader Interactive Guide to Emotions per week for 12 weeks. compared to two 45-minute sessions of PositScience, plus one 45-min Discussion session plus one minute of Mind Reader, Interactive Guide to Emotions
Behavioral: CRT and Social Cognition
Mind Reading, The Interactive Guide to Emotions for one 45 minute session per week for 12 weeks.
Other Name: Social Emotional Functioning

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 and above;
  2. In- and out-patients;
  3. DSM-IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder with illness duration >5 years;
  4. Auditory and visual acuity adequate to complete cognitive tests;
  5. Stable dose of oral atypical antipsychotic for at least 4 weeks;
  6. Total PANSS score > 60;
  7. Good physical health determined by physical examination from medical chart review;
  8. Capacity and willingness to give written informed consent.
  9. MMSE > 24

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01036282

United States, New York
Manhattan Psychiatric Center
New York, New York, United States, 10605
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Manhattan Psychiatric Center
Principal Investigator: Jean-Pierre Lindenmayer, M.D. Nathan S. Kline Institute for Psychiatric Research and Manhattan Psychiatric Center

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jean-Pierre Lindenmayer, Director of Research, Nathan Kline Institute for Psychiatric Research Identifier: NCT01036282     History of Changes
Other Study ID Numbers: 03I/C14
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders