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CompletedNCT01036282Updated Jul 21, 2017

Cognitive Skills Training Using Computer for Patients With Severe Mental Illness

A Phase 4 interventional study of Computerized Cognitive Skill Training and CRT and Social Cognition in Schizophrenia and Schizoaffective Disorder, sponsored by Nathan Kline Institute for Psychiatric Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-21.

Sponsored by Nathan Kline Institute for Psychiatric Research · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 10 months after the study started (first participant enrolled Feb 2003, registered Dec 2009).
Phase
Phase 4
Study type
Interventional
Enrollment
448
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder
03

In context

Schizophrenia

3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's enrollment of 448 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Nathan Kline Institute for Psychiatric Research is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
448 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralComputerized Cognitive Skill Training

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

    Also known as: Cognitive Remediation Therapy

  • BehavioralCRT and Social Cognition

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

    Also known as: Social Emotional Functioning

06

What researchers measure

Primary outcomes

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

    Comprehensive battery of neuro-cognitive tests

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

Secondary outcomes

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

    Test of facial emotion presentations on pictures to patients

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

  2. Personal and Social Performance Scale (PSP)

    Social function scale with four sub domains of social functioning

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

  3. Positive and Negative Syndrome Scale (PANSS)

    30 item Gold standard for measurement of psychiatric symptoms

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

07

Study locations

1 site
  • Manhattan Psychiatric Center
    New York, New York 10605, United States
08

References and documents

Publications

  • Lindenmayer JP, McGurk SR, Mueser KT, Khan A, Wance D, Hoffman L, Wolfe R, Xie H. A randomized controlled trial of cognitive remediation among inpatients with persistent mental illness. Psychiatr Serv. 2008 Mar;59(3):241-7. doi: 10.1176/ps.2008.59.3.241. PubMed 18308903 ↗
  • Lindenmayer JP, Fregenti S, Kang G, Ozog V, Ljuri I, Khan A, Goldring A, McGurk SR. The relationship of cognitive improvement after cognitive remediation with social functioning in patients with schizophrenia and severe cognitive deficits. Schizophr Res. 2017 Jul;185:154-160. doi: 10.1016/j.schres.2017.01.007. Epub 2017 Jan 13. PubMed 28094171 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01036282
Lead sponsor
Nathan Kline Institute for Psychiatric Research
Collaborators
Manhattan Psychiatric Center
Responsible party
Jean-Pierre Lindenmayer (Director of Research, Nathan Kline Institute for Psychiatric Research) — Principal investigator
First posted
Dec 21, 2009
Start date
Feb 2003
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jul 21, 2017

Study contacts

Jean-Pierre Lindenmayer, M.D.
principal investigator · Nathan S. Kline Institute for Psychiatric Research and Manhattan Psychiatric Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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