Cognitive Skills Training Using Computer for Patients With Severe Mental Illness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Nathan Kline Institute for Psychiatric Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT01036282
First received: December 18, 2009
Last updated: June 2, 2011
Last verified: June 2011
  Purpose

The study is designed to evaluate the effectiveness of computerized cognitive skills training for improving memory and problem-solving skills in inpatients with schizophrenia.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Behavioral: Computerized Cognitive Skill Training
Behavioral: CRT and Social Cognition
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Computerized Cognitive Skills Training in Severe Mental Illness

Resource links provided by NLM:


Further study details as provided by Nathan Kline Institute for Psychiatric Research:

Primary Outcome Measures:
  • Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) [ Time Frame: Week 0, and Week 12 (after completion of Cognitive Remediation) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Facial Emotional Discrimination Task (FEDT) and Facial Emotional Identification Task (FEIT) [ Time Frame: Week 0, and Week 12 (after compeltion of Cognitive Remediation) ] [ Designated as safety issue: No ]
  • Personal and Social Performance Scale (PSP) [ Time Frame: Week 0, and Week 12 after completion of Cognitive Remediation ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Week 0, Week 6 (Midpoint) and Week 12 after completion of Cognitive Remediation ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2003
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computerized Cognitive Remediation
Computerized Cognitive Remediation treatment using COGPACK.
Behavioral: Computerized Cognitive Skill Training
Behavioral: Cognitive Remediation 45 mins 2 times per week sessions of cognitive remediation (COGPACK) over twelve weeks.
Other Name: Cognitive Remediation Therapy
Experimental: CRT + Social Cognition Training
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.
Behavioral: CRT and Social Cognition
Mind Reading, The Interactive Guide to Emotions for one 45 minute session per week for 12 weeks.
Other Name: Social Emotional Functioning

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01036282

Contacts
Contact: Anzalee Khan, PhD AKhan@nki.rfmh.org
Contact: Theresa Abad, RN, MSN manrtla@omh.state.ny.us

Locations
United States, New York
Manhattan Psychiatric Center Recruiting
New York, New York, United States, 10605
Principal Investigator: Jean-Pierre Lindenmayer, MD         
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Investigators
Principal Investigator: Jean-Pierre Lindenmayer, M.D. Nathan S. Kline Institute for Psychiatric Research and Manhattan Psychiatric Center
  More Information

Publications:
Responsible Party: Jean-Pierre Lindenmayer, M.D., Nathan S. Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier: NCT01036282     History of Changes
Other Study ID Numbers: 03I/C14
Study First Received: December 18, 2009
Last Updated: June 2, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 16, 2014