Cognitive Skills Training Using Computer for Patients With Severe Mental Illness

Phase 4

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Behavioral: CRT and Social Cognition; Behavioral: Computerized Cognitive Skill Training

• Registration Number: NCT01036282
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-02
• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 448

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRT + Social Cognition Training	CRT and Social Cognition	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
Computerized Cognitive Remediation	Computerized Cognitive Skill Training	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Manhattan Psychiatric Center; 🇺🇸 New York, New York, United States