Evaluating Two Types of Cognitive Training in Veterans With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Cognitive dysfunction is a major contributor to the poor community outcome of individuals
      with schizophrenia. Developing more effective cognitive remediation interventions is
      imperative to improve the daily lives of affected subjects and reduce the disability of this
      illness. The goal of this clinical trial is to evaluate two types of cognitive training
      approaches to determine which one is more beneficial for individuals with schizophrenia. This
      study also uses electrophysiological techniques to gain a better understanding of the
      mechanisms involved in cognitive remediation. Findings from this study will provide
      information about how to design the most optimally efficient cognitive training intervention
      to improve the cognitive and social functioning of patients with severe mental illness.
    

Detailed description: 
      Schizophrenia is a disorder that affects both higher-level neurocognitive operations (e.g.,
      verbal memory, executive functioning) and lower-level perceptual processes (e.g., auditory
      processing). These deficits contribute to the poor community outcome and severe functional
      disability seen in patients. Effectively treating the cognitive dysfunction associated with
      this illness is important to achieve improvements in daily functioning. Recent meta-analytic
      studies report that cognitive training in schizophrenia has a moderate effect-size impact on
      cognitive functioning and a lower impact on daily functioning. However, most training
      interventions for schizophrenia have only targeted higher-order cognitive processes. A few
      recent interventions have targeted basic perceptual processing and shown that auditory and
      visual perceptual abilities can be trained and improved in patients with schizophrenia. These
      findings suggest that basic perceptual processing may be an ideal target for intervention. At
      this point, it is still unclear whether a neuroplasticity-based, bottom-up intervention is
      more effective than an intervention that targets top-down functions like attention, working
      memory, and executive functioning.

      This clinical trial will contrast a bottom-up intervention targeting basic auditory processes
      and a top-down intervention targeting higher-order cognitive functions, compared with a
      control condition, in Veterans with schizophrenia. These interventions will be assessed by
      their effects on representative measures from three outcome domains: 1) neurocognition, 2)
      electroencephalography (EEG), and 3) functional capacity. Participants will be randomly
      assigned to the bottom-up auditory training, top-down cognitive training, or control
      treatment (commercial computer games). All treatments will be administered three times a week
      (1 hour each) for 12 weeks. A comprehensive battery of cognitive, electrophysiological, and
      functional measures will be administered at baseline, 6 weeks, and at completion of
      treatment. The investigators will enroll 120 Veterans with schizophrenia or schizoaffective
      disorder across the 5 years of the study.

      This study will determine which training approach leads to the largest magnitude of
      improvement in neurocognition, functional capacity, and neural functioning measured with EEG.
      Moreover, it will shed light on the neural mechanisms underlying the response to training. By
      determining whether it is more beneficial to treat lower-level perceptual processes or
      higher-level cognitive functions, the results of this project will inform future
      recovery-based cognitive remediation interventions for Veterans with schizophrenia.
    

Intervention name(s): Brain Fitness Program (BFP); Cognitive Package (Cogpack); Commercial Computer Games (Sporcle)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): This computerized "bottom-up" cognitive intervention is designed to improve the speed and accuracy of auditory information processing through increasingly more difficult stimulus recognition, discrimination, sequencing, and memory tasks under conditions of close attentional control, high reward, and novelty. BFP consists of 6 exercises. Stimuli across the exercises are chosen such that they span the acoustic and organizational structure of speech, from very simple acoustic stimuli and tasks to complex manipulations of continuous speech. The exercises adaptively progress based on the subject's individual performance during a training session and become more challenging as the subject's abilities improve. Participants will work with 4 of the 6 exercises (15 min per exercise) in each session.; This computerized "top-down" cognitive intervention is designed to provide training across a broad range of cognitive functions. Cogpack consists of domain-specific exercises aimed at training specific cognitive areas (attention, working memory, verbal and visual memory, executive functioning, reasoning, language) and non-domain-specific exercises that require the use of several functions at a time. Cogpack includes low-level cognitive exercises (i.e., scanning, hand-eye coordination, and psychomotor speed) that will not be included in this protocol to better separate bottom-up from top-down training interventions. There will be a total of 34 exercises and variants of the same exercises with different levels of difficulty. In each session, participants will work on a different subset of 4 to 6 exercises.; Sporcle computer games will be used as a "placebo" treatment to control for the effects of computer exposure, contact with research personnel, time spent being cognitively active, and financial compensation for participation. The games cover trivia-type questions about geography, entertainment, science, history, literature, sports, movies, etc. Subjects will receive the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They will also complete 3 hours of "training" per week over 12 weeks, for a total of 36 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive training; schizophrenia; mismatch negativity; cognition; functional capacity; EEG