Feasibility of Providing Cognitive Remediation to People With Schizophrenia in a Clinical Network

Study Overview
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Brief Summary
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This study will test whether a cognitive remediation program to treat people with schizophrenia can be successfully implemented in a network of research clinics.

Detailed Description
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Neurocognitive impairments, or problems with thinking and brain function, are a core component of schizophrenia. Such impairments, which can range from moderate to severe, are strongly associated with decreased benefit from psychiatric rehabilitation and problems with treatment adherence, socialization, employment, quality of life, and relapse. Researchers believe that the failure of medication to improve cognition may occur because medication treatment lacks cognitive stimulation. Cognitive remediation programs are a way to provide that stimulation, and they have shown moderate efficacy in improving cognition in people with schizophrenia. Implementing these cognitive remediation programs as part of schizophrenia treatment has occurred only at individual sites with highly trained research personnel. This study will test whether cognitive remediation programs for schizophrenia can be feasibly implemented at a network of sites that do not specialize in cognitive remediation research. This pilot study will gather preliminary efficacy data, but a larger study is required to draw definitive conclusions about treatment effects. Participation in this study will last approximately 8 weeks. Participants will be randomly assigned to the Posit Science intervention group or the control group. Those in the Posit Science group will receive targeted cognitive training (TCT)-40 hours of adaptive computer exercises-and participate in a weekly bridging group that helps participants apply cognitive skills to everyday contexts. Length of the TCT may vary, depending on the availability of participants to complete the exercises. Those in the control group will play commercially available video games for the same number of hours and participate in a weekly health and wellness group. All participants will undergo assessments at baseline, mid-treatment, and post-treatment. Assessments will include self-report questionnaires and clinical interviews.

Official Title
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Cognitive Remediation in the Schizophrenia Trials Network

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Targeted cognitive training
* Behavioral: Computer control
* Behavioral: Bridging groups
* Behavioral: Health and wellness groups


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Demonstrates adequate decisional capacity to make a choice about participating in the research study Diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID) Positive and Negative Syndrome Scale (PANSS) hallucinatory behavior, unusual thought content, and conceptual disorganization ratings of no greater than moderately severe (i.e., item scores must be less than or equal to 5) Meets all of the following cognitive performance and English language criteria: Learned English before age 12 Able to complete the baseline Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) validly, based on the judgment of the investigator Raw score of 37 or greater on the Wide Range Achievement Test, reading subtest, 3rd edition (WRAT-3), used to establish minimum sixth grade reading level and estimated premorbid IQ Able to state specific goals relevant to the intervention that participant would like to achieve Able to participate in the computerized intervention, based on the judgment of the investigator Exclusion Criteria: Psychiatric hospitalization within 8 weeks of random assignment Adjustment to antipsychotic treatment within 4 weeks of random assignment Currently taking an anticholinergic medication DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months History of mental retardation, pervasive developmental disorder, or other neurological disorder (such as a traumatic brain injury, epilepsy, or Parkinson 's disease)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posit Science Intervention<br>Participants will receive targeted cognitive training and participate in a bridging group. | Behavioral: Targeted cognitive training<br>* Adaptive computer exercises that systematically increase in task difficulty as each participant's performance ability improves<br>Behavioral: Bridging groups<br>* Weekly group meetings that help participants apply their cognitive skills to everyday functioning, promote group identity, and promote socialization<br>|
| Active Comparator: Control<br>Participants will play commercially available computer games and participate in weekly groups to discuss health and wellness. | Behavioral: Computer control<br>* Commercially available computer games selected based on quality, ability to hold interest, and lack of disturbing content<br>Behavioral: Health and wellness groups<br>* Weekly group meetings that teach participants health and wellness skills<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a multisite trial using cognitive remediation |  | Measured at post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of cognitive remediation on functional outcomes, including change from baseline on UCSD Performance Based Skills Assessment (UPSA) total score, Specific Levels of Functioning (SLOF) total score, and Cognitive Assessment Interview (CAI) total score |  | Measured at post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizoaffective Disorder