Cognitive Skills Training Using Computer for Patients With Severe Mental Illness

Schizophrenia Clinical Trial

Official title:

Computerized Cognitive Skills Training in Severe Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01036282
• Other study ID #: 03I/C14
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2009
• Last updated: July 18, 2017
• Start date: February 2003
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Nathan Kline Institute for Psychiatric Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Computerized Cognitive Skill Training
Behavioral: Cognitive Remediation 45 mins 2 times per week sessions of cognitive remediation (COGPACK) over twelve weeks.
• CRT and Social Cognition
Mind Reading, The Interactive Guide to Emotions for one 45 minute session per week for 12 weeks.

Locations

Country	Name	City	State
United States	Manhattan Psychiatric Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Nathan Kline Institute for Psychiatric Research	Manhattan Psychiatric Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/appi.ps.59.3.241. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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