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Cognitive Skills Training Using Computer for Patients With Severe Mental Illness

Computerized Cognitive Skills Training in Severe Mental Illness

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01036282
Enrollment
448
Registered
2009-12-21
Start date
2003-02-28
Completion date
2016-12-31
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia

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.

Interventions

BEHAVIORALComputerized Cognitive Skill Training

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

BEHAVIORALCRT and Social Cognition

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

Sponsors

Manhattan Psychiatric Center
CollaboratorOTHER
Nathan Kline Institute for Psychiatric Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Raters were blind to the type of interventions

Intervention model description

Two arm, parallel group, randomized, blinded 12 -week intervention study of two forms of cognitive remediation in patients with chronic schizophrenia

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 RemediationSocial 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 Remediation30 item Gold standard for measurement of psychiatric symptoms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026