Cognitive Skills Training Using Computer for Patients With Severe Mental Illness

NCT ID: NCT01036282

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 448 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2016-12-31

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Computerized Cognitive Remediation

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).

Group Type: EXPERIMENTAL

Computerized Cognitive Skill Training

Intervention Type: BEHAVIORAL

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

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. compared to two 45-minute sessions of PositScience, plus one 45-min Discussion session plus one minute of Mind Reader, Interactive Guide to Emotions

Group Type: EXPERIMENTAL

CRT and Social Cognition

Intervention Type: BEHAVIORAL

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

Interventions

Computerized Cognitive Skill Training

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

Intervention Type: BEHAVIORAL

CRT and Social Cognition

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Cognitive Remediation Therapy; Social Emotional Functioning

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manhattan Psychiatric Center

OTHER

Sponsor Role: collaborator

Nathan Kline Institute for Psychiatric Research

OTHER

Sponsor Role: lead

Responsible Party

Jean-Pierre Lindenmayer

Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Pierre Lindenmayer, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Manhattan Psychiatric Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18308903 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28094171 (View on PubMed)

Other Identifiers

03I/C14

Identifier Type: -

Identifier Source: org_study_id