Cognitive Skills Training Using Computer for Patients With Severe Mental Illness

Computerized Cognitive Skills Training in 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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Behavioral: Computerized Cognitive Skill Training; Behavioral: CRT and Social Cognition

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
• Enrollment (Actual): 448
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10605
      • Manhattan Psychiatric Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Social Emotional Functioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)	Comprehensive battery of neuro-cognitive tests	Week 0, and Week 12 (after completion of Cognitive Remediation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial Emotional Discrimination Task (FEDT) and Facial Emotional Identification Task (FEIT)	Test of facial emotion presentations on pictures to patients	Week 0, and Week 12 (after compeltion of Cognitive Remediation)
Personal and Social Performance Scale (PSP)	Social function scale with four sub domains of social functioning	Week 0, and Week 12 after completion of Cognitive Remediation
Positive and Negative Syndrome Scale (PANSS)	30 item Gold standard for measurement of psychiatric symptoms	Week 0, Week 6 (Midpoint) and Week 12 after completion of Cognitive Remediation

Collaborators and Investigators

• Sponsor: Nathan Kline Institute for Psychiatric Research
• Collaborators: Manhattan Psychiatric Center
• Investigators: Principal Investigator: Jean-Pierre Lindenmayer, M.D., Nathan S. Kline Institute for Psychiatric Research and Manhattan Psychiatric Center

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2003
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 18, 2009
• First Submitted That Met QC Criteria: December 18, 2009
• First Posted (Estimate): December 21, 2009

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 03I/C14