NCT00930150

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

Cognitive Remediation in the Schizophrenia Trials Network

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: National Institute of Mental Health (NIMH) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
BEHAVIORAL	Targeted cognitive training	Adaptive computer exercises that systematically increase in task difficulty as each participant's performance ability improves
BEHAVIORAL	Computer control	Commercially available computer games selected based on quality, ability to hold interest, and lack of disturbing content
BEHAVIORAL	Bridging groups	Weekly group meetings that help participants apply their cognitive skills to everyday functioning, promote group identity, and promote socialization
BEHAVIORAL	Health and wellness groups	Weekly group meetings that teach participants health and wellness skills

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-06-30
• Last updated: 2011-04-19

Locations

9 sites across 1 country: United States