Personalized and Scalable Cognitive Remediation Approaches

There are three phases of this study.

Phase 1: Development and Adaptation. The goal of this phase is to adapt currently used
computer based CR approaches to make them more personalized and scalable. We will create two
CR interventions which differ in choice and pacing of the cognitive exercises. This phase is
complete.

Phase 2: Open Trial and Intervention Refinement. The goal of this phase is to obtain
quantitative and qualitative feedback on the acceptability and usability of the interventions
from participants to inform further refinement of the assessment and treatment packages. We
will recruit ten subjects from an outpatient psychiatric rehabilitation program in New York
City. After determining study eligibility, individuals will complete a standardized
neuropsychological battery for schizophrenia assessment, and a 5-minute Tone Matching Test to
assess basic auditory processing. Participants will be randomly assigned to receive one of
two intervention packages, developed in Phase 1. Each session includes 60 minutes of
computer-based learning activities and a 15 minute therapist-led discussion that links the
computer activities to cognition as applied to daily tasks and recovery goals. Participants
will complete a total of 10 sessions attending 2-3 times weekly for 5 weeks. During each
session, participants will be asked to keep a log of software used. At the conclusion of this
abbreviated trial, the participants will participate in focus groups in which they will be
asked to provide verbal feedback on how enjoyable, engaging, and useful they perceived the
computer and discussion based exercises to be. Participants will be asked to provide verbal
feedback on the assessment procedures. CR clinicians will join the research team to discuss
participants' engagement and their experience with administering the Tone Matching Test and
interventions. Qualitative data summarized from participant logs and focus groups will be
considered by the research team to refine the assessment battery, treatment parameters, and
rubric of learning exercises. This phase is complete.

Phase 3: Pilot Feasibility Trial. People with a diagnosis of schizophrenia or schizoaffective
disorder may be referred by their treating clinician or may respond to posted advertisements
to inquire about study participation. After being informed of study procedures, interested
individuals will be asked to sign a consent form that documents willingness to participate in
this study. Following informed consent, participants will be asked questions about
demographic characteristics (e.g. age, education, employment), medication and psychosocial
treatment status, psychiatric symptoms and symptoms severity, and will complete a brief
assessment of estimated Intelligence. Those with an Intelligence Quotient (IQ) estimate below
70 or meeting substance dependence criteria at the time of evaluation will be exited from the
study. In the same or second assessment session, participants will complete assessments of
neuropsychological ability, current functioning, and motivation for treatment. Participants
will then be randomly assigned to one of two treatment conditions named "Brain Basics" or
"Brain Exercises".

Each treatment condition is structured in a group format of up to 5 participants. Both
treatments use commercially available computer-based training software to exercise cognitive
skills such as speed of processing, attention, working memory, and verbal memory. Both
conditions will entail 50 minutes on the computer and 10 minutes group discussion. In the
discussion, participants review the cognitive activities they are working on and how they
will help them achieve their recovery goals. The treatment phase will consist of 30 separate
sessions each 60 minutes in duration, administered 3 times a week over the course of a
10-week period. Participants will be re-tested on outcome measures approximately 1 week
following end of treatment, and again 3 months later.

Inclusion Criteria:

1. Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of schizophrenia or
schizoaffective disorder

2. Age 18 to 65

3. English speaking

4. Psychiatrically stable, verified by current living/treatment status

Exclusion Criteria:

1. Indication of mental retardation, determined by estimated IQ of less than 70

2. Hearing or visual impairment that precludes completing assessments

3. Neurologic illness that may affect brain physiology (e.g. Parkinson's, seizure
disorder, epilepsy)

4. Current substance dependence symptoms in the past 6 weeks

5. Participation in cognitive remediation in the 12 months prior to study entry.