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

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: Targeted cognitive training; Behavioral: Computer control; Behavioral: Bridging groups; Behavioral: Health and wellness groups

• Registration Number: NCT00930150
• Lead Sponsor: National Institute of Mental Health (NIMH)

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-06-26
• Study First Submitted QC: 2009-06-26
• Study First Posted: 2009-06-30
• Study Start: 2009-07
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-11
• Last Update Submitted: 2011-04-15
• Last Update Posted: 2011-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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:

  1. Learned English before age 12
  2. 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
  3. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posit Science Intervention	Targeted cognitive training	Participants will receive targeted cognitive training and participate in a bridging group.
Posit Science Intervention	Bridging groups	Participants will receive targeted cognitive training and participate in a bridging group.
Control	Computer control	Participants will play commercially available computer games and participate in weekly groups to discuss health and wellness.
Control	Health and wellness groups	Participants will play commercially available computer games and participate in weekly groups to discuss health and wellness.

Primary Outcome Measures

Name	Time	Method
Feasibility of a multisite trial using cognitive remediation	Measured at post-treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Philadelphia VA Medical Center-116A; 🇺🇸 Philadelphia, Pennsylvania, United States

Yale University/Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States

The University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Medical College of Georgia; 🇺🇸 Augusta, Georgia, United States

University of Iowa Hospital; 🇺🇸 Iowa City, Iowa, United States

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

University of Minnesota School of Medicine; 🇺🇸 Minneapolis, Minnesota, United States