Cognitive Skills Training Using Computer for Patients With Severe Mental Illness

NCT01036282 | Completed Phase 4 DMC

• 1 other identifier: 03I/C14
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Facial Emotional Discrimination Task (FEDT) and Facial Emotional Identification Task (FEIT)

  Week 0, and Week 12 (after compeltion of Cognitive Remediation)

• Personal and Social Performance Scale (PSP)

  Week 0, and Week 12 after completion of Cognitive Remediation

• Positive and Negative Syndrome Scale (PANSS)

  Week 0, Week 6 (Midpoint) and Week 12 after completion of Cognitive Remediation

Study Arms (2)

Computerized Cognitive Remediation

EXPERIMENTAL

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

CRT + Social Cognition Training

EXPERIMENTAL

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

Interventions

Computerized Cognitive Skill Training BEHAVIORAL

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

Also known as: Cognitive Remediation Therapy

Computerized Cognitive Remediation

CRT and Social Cognition BEHAVIORAL

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

Also known as: Social Emotional Functioning

CRT + Social Cognition Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above;
• In- and out-patients;
• DSM-IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder with illness duration \>5 years;
• Auditory and visual acuity adequate to complete cognitive tests;
• Stable dose of oral atypical antipsychotic for at least 4 weeks;
• Total PANSS score \> 60;
• Good physical health determined by physical examination from medical chart review;
• Capacity and willingness to give written informed consent.
• MMSE \> 24

You may not qualify if:

• Inability to read or speak English;
• Documented disease of the central nervous system;
• History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation);
• Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematological conditions;
• HIV +;
• Patients diagnosed with substance dependence;
• Currently participating in another experimental study.

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead
• Manhattan Psychiatric Center: collaborator

Study Sites (1)

Manhattan Psychiatric Center

New York, New York, 10605, United States

Location

Related Publications (2)

• 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.

  PMID: 18308903 RESULT

• 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.

  PMID: 28094171 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jean-Pierre Lindenmayer, M.D.

  Nathan S. Kline Institute for Psychiatric Research and Manhattan Psychiatric Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Raters were blind to the type of interventions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

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

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 21, 2009
• Study Start: February 1, 2003
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)