Remediation of Working Memory in Schizophrenia

VA Office of Research and Development

Status: Completed

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Behavioral: Cognitive Remediation; Behavioral: Computer Skills

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00995553

D6981-R

1I01RX000180-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The primary aim of the study is to test the efficacy of a novel cognitive remediation intervention that targets working memory-related functions. To accomplish this goal, 80 volunteer patients with schizophrenia will be enrolled and randomized to either a cognitive remediation condition that targets working memory or a computer skills training intervention that teaches computer applications. In both conditions participants will receive computer training three times a week for 4 months. The investigators hypothesize that patients who receive the cognitive remediation intervention will demonstrate significantly greater change on neuropsychological measures of working memory and executive abilities than patients who receive the computer skills course. In addition, the investigators hypothesize that the intervention-induced cognitive change will be associated with concurrent improvements in functional capacity and psychosocial functioning in the community. A second study goal is to examine the stability of the intervention-induced changes in cognition. Cognition and psychosocial functioning will be reassessed 4 and 8 months after treatment termination to examine the stability of treatment effects and to assess whether a less intense maintenance training (once a week sessions) provides any additional benefit to participants. Lastly, this study will examine in an exploratory manner whether there are individual differences in treatment response. The Val158Met polymorphism of the COMT gene has been found to be associated with working memory and prefrontal dysfunction in schizophrenia. The study will test whether the COMT polymorphism is predictive of response to cognitive remediation.

Enrollment: 86 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Veterans with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder
• No hospitalizations in the previous 4 weeks
• No antipsychotic medication changes in the previous 4 weeks
• Age 18-60
• Does not meet DSM-IV criteria for substance dependence in the previous 6 months or substance abuse in the previous month

Exclusion criteria

• History of clinically significant head injury or neurological disease
• Poor comprehension of the English language
• History of diagnosis of mental retardation or pervasive developmental disorder
• Unable to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups, including a placebo group

Cognitive Remediation

Experimental group

Description:

A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.

Treatment:

Behavioral: Cognitive Remediation

Computer Skills

Placebo Comparator group

Description:

This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.

Treatment:

Behavioral: Computer Skills