Clinical trial NCT01036282: Cognitive Skills Training Using Computer for Patients With Severe Mental Illness
Official title: Computerized Cognitive Skills Training in Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Nathan Kline Institute for Psychiatric Research
Sponsor class: OTHER
Collaborators: name: Manhattan Psychiatric Center
First posted: 2009-12-21
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm, parallel group, randomized, blinded 12 -week intervention study of two forms of cognitive remediation in patients with chronic schizophrenia
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
timeFrame: Week 0, and Week 12 (after completion of Cognitive Remediation)
Secondary outcomes:
measure: Facial Emotional Discrimination Task (FEDT) and Facial Emotional Identification Task (FEIT)
timeFrame: Week 0, and Week 12 (after compeltion of Cognitive Remediation)
measure: Personal and Social Performance Scale (PSP)
timeFrame: Week 0, and Week 12 after completion of Cognitive Remediation
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Week 0, Week 6 (Midpoint) and Week 12 after completion of Cognitive Remediation
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Psychiatric Center
state: New York
Study officials:
affiliation: Nathan S. Kline Institute for Psychiatric Research and Manhattan Psychiatric Center
name: Jean-Pierre Lindenmayer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.