Personalized and Scalable Cognitive Remediation Approaches
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to develop and pilot test personalized and scalable approaches
      to Cognitive Remediation (CR) for schizophrenia and schizoaffective disorder. The intent is
      to more clearly define the therapeutic targets important to the facilitation of cognitive and
      functional improvement so that clinicians know how to customize cognitive interventions and
      deliver treatment in a more effective, efficient and personally relevant manner.
    

Detailed description: 
      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.
    

Intervention name(s): Cognitive remediation
Intervention type(s): Behavioral
Intervention description(s): Cognitive remediation sessions include working on computer based cognitive exercises and participating in a verbal discussion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive remediation; Schizophrenia; Schizoaffective disorder