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Cognitive Skills Training Using Computer for Patients With Severe Mental Illness

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Computerized Cognitive Skill Training
CRT and Social Cognition
Sponsored by
Nathan Kline Institute for Psychiatric Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Manhattan Psychiatric Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Computerized Cognitive Remediation

CRT + Social Cognition Training

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Comprehensive battery of neuro-cognitive tests

Secondary Outcome Measures

Facial Emotional Discrimination Task (FEDT) and Facial Emotional Identification Task (FEIT)
Test of facial emotion presentations on pictures to patients
Personal and Social Performance Scale (PSP)
Social function scale with four sub domains of social functioning
Positive and Negative Syndrome Scale (PANSS)
30 item Gold standard for measurement of psychiatric symptoms

Full Information

First Posted
December 18, 2009
Last Updated
July 18, 2017
Sponsor
Nathan Kline Institute for Psychiatric Research
Collaborators
Manhattan Psychiatric Center
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1. Study Identification

Unique Protocol Identification Number
NCT01036282
Brief Title
Cognitive Skills Training Using Computer for Patients With Severe Mental Illness
Official Title
Computerized Cognitive Skills Training in Severe Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2003 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nathan Kline Institute for Psychiatric Research
Collaborators
Manhattan Psychiatric Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Two arm, parallel group, randomized, blinded 12 -week intervention study of two forms of cognitive remediation in patients with chronic schizophrenia
Masking
Outcomes Assessor
Masking Description
Raters were blind to the type of interventions
Allocation
Randomized
Enrollment
448 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerized Cognitive Remediation
Arm Type
Experimental
Arm Description
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).
Arm Title
CRT + Social Cognition Training
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Computerized Cognitive Skill Training
Other Intervention Name(s)
Cognitive Remediation Therapy
Intervention Description
Behavioral: Cognitive Remediation 45 mins 2 times per week sessions of cognitive remediation (COGPACK) over twelve weeks.
Intervention Type
Behavioral
Intervention Name(s)
CRT and Social Cognition
Other Intervention Name(s)
Social Emotional Functioning
Intervention Description
Mind Reading, The Interactive Guide to Emotions for one 45 minute session per week for 12 weeks.
Primary Outcome Measure Information:
Title
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Description
Comprehensive battery of neuro-cognitive tests
Time Frame
Week 0, and Week 12 (after completion of Cognitive Remediation)
Secondary Outcome Measure Information:
Title
Facial Emotional Discrimination Task (FEDT) and Facial Emotional Identification Task (FEIT)
Description
Test of facial emotion presentations on pictures to patients
Time Frame
Week 0, and Week 12 (after compeltion of Cognitive Remediation)
Title
Personal and Social Performance Scale (PSP)
Description
Social function scale with four sub domains of social functioning
Time Frame
Week 0, and Week 12 after completion of Cognitive Remediation
Title
Positive and Negative Syndrome Scale (PANSS)
Description
30 item Gold standard for measurement of psychiatric symptoms
Time Frame
Week 0, Week 6 (Midpoint) and Week 12 after completion of Cognitive Remediation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Lindenmayer, M.D.
Organizational Affiliation
Nathan S. Kline Institute for Psychiatric Research and Manhattan Psychiatric Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Psychiatric Center
City
New York
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18308903
Citation
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.
Results Reference
result
PubMed Identifier
28094171
Citation
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.
Results Reference
derived

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Cognitive Skills Training Using Computer for Patients With Severe Mental Illness

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