A Phase 4 interventional study of Targeted cognitive training and Computer control in Schizophrenia, sponsored by National Institute of Mental Health (NIMH). Completed at 9 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2011-04-19.
Sponsored by National Institute of Mental Health (NIMH) · Phase 4, Interventional, and Treatment
This study will test whether a cognitive remediation program to treat people with schizophrenia can be successfully implemented in a network of research clinics.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 52 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →National Institute of Mental Health (NIMH) is the lead sponsor of 359 studies on the registry; 46 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
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Meets all of the following cognitive performance and English language criteria:
Exclusion Criteria:
Participants will receive targeted cognitive training and participate in a bridging group.
Behavioral: Targeted cognitive training · Behavioral: Bridging groups
Participants will play commercially available computer games and participate in weekly groups to discuss health and wellness.
Behavioral: Computer control · Behavioral: Health and wellness groups
Adaptive computer exercises that systematically increase in task difficulty as each participant's performance ability improves
Commercially available computer games selected based on quality, ability to hold interest, and lack of disturbing content
Weekly group meetings that help participants apply their cognitive skills to everyday functioning, promote group identity, and promote socialization
Weekly group meetings that teach participants health and wellness skills
Feasibility of a multisite trial using cognitive remediation
Time frame: Measured at post-treatment
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
Time frame: Measured at post-treatment
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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National Institute of Mental Health (NIMH)