Reasoning Training in Individuals With Bipolar Disorder
Condition: Bipolar Disorder; Cognitive Ability, General
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to examine cognitive and brain changes in individuals with
      bipolar disorder as a result of a cognitive training intervention.
    

Detailed description: 
      The experiment will be undertaken with the understanding and written consent of each subject.
      Participants will only include people who are fluent speakers of English, as not all of the
      standardized and experimental cognitive tests have been normed for non-English speakers.
      Participants will be screened for significant medical, neurological, or psychiatric illness
      other than bipolar disorder. Additionally, two separate neuropsychological cognitive testing
      and two functional magnetic resonance imaging (fMRI) imaging procedures will be conducted
      with each participant: one at baseline prior to cognitive training, the second at the end of
      cognitive training (4 weeks). These testing procedures are explained below.

      Each participant will receive an appoint card/schedule of appointments to help them keep
      track of what is expected of them. During the training program participants will make 1 visit
      per week for 2 hours each over a 4-week period. Prior to cognitive training, participants'
      baseline gist and detail processing ability, battery of cognitive functions and
      neuropsychological measures will be obtained with a battery of cognitive measures. Structural
      and functional brain measures will also be obtained. All measurements will be taken again at
      the endpoint of training. Training effects will be measured behaviorally in trained areas
      (reasoning & physical) and untrained cognitive areas. Additionally, structural and functional
      brain imaging will measure changes in cerebral blood flow, global and regional brain volume,
      white matter tracts, efficiency, activation patterns, and blood oxygenation with a particular
      focus on changes to frontal regions.

      Screening Session: A research assistant will conduct screening procedures over the phone
      including a brief medical questionnaire covering their history, current medications and any
      pre-existing conditions. Prior diagnosis of bipolar disorder and euthymic state will be
      confirmed with participant's psychiatrist or treating physician. Given that the participant
      meets the requirements covered by the phone screen, participants will be asked to complete
      further screening.

      Neurocognitive Testing Session: A clinician will administer a group of standardized and
      experimental tests to each participant for each of the cognitive testing sessions. This
      session may last up to 3 hours, depending on the pace of the participant's response times.
      The intent of the tasks is to assess higher level thinking skills, working memory, and
      selective learning. The testing will be done at the Center for BrainHealth at 2200 W.
      Mockingbird Lane, Dallas, Texas. At the cognitive testing session, participants will sign a
      release form, and clinicians will fax both the release and 'approval form' to the physician.

      The neuropsychological cognitive test battery will include tests like Delis-Kaplan Executive
      Function System (DKEFS) Color-Word Interference Test, Delis-Kaplan Executive Function System
      (DKEFS) Card Sorting Test, Test of Strategic Learning (TOSL), Auditory Selective Learning,
      Wechsler Memory Scale (WMS-III) Logical Memory Subtest, Verbal Problem Solving, Wechsler
      Adult Intelligence Scale (WAIS) Similarities Subtest, Rey-Osterrieth Auditory Verbal Learning
      Test (RAVLT), Trails A, Trails B, the Controlled Order Word Association Test (COWAT),
      Wechsler Memory Scale (WMS-III) Digits forward and backwards, and Framing task.

      Functional magnetic resonance imaging (fMRI): On separate days, the participants will have
      fMRI, at each aforementioned time point in the study, during which they will lie in the
      scanner while images of their brain will be recorded. Each session will take up to 90
      minutes. During the fMRI and during the diffusion tensor imaging (DTI) the patient will be
      asked just to lie still.

      Cognitive reasoning training: The gist-based reasoning training will be delivered in one, two
      hour session each week over 4 weeks. Participants may also receive training individually and
      through online training sessions instead of in a group setting. It is strategy-based rather
      than content-based so that the focus is not content specific or situation-dependent.
      Gist-based reasoning has been linked to frontal lobe activation and to measures of executive
      function. Potentially, the learned strategies could be applied across a variety of living
      contexts such as attending lectures, going to the movies, following news stories, planning
      and carrying out a project, and understanding brochures outlining changes in health care
      benefits, to name a few. The strategy instruction is hierarchical and dynamically
      interdependent, with each strategy building upon previous strategies to transform the
      concrete meaning into abstracted gist-based meanings through reasoning and inference.
      Constructing meaning at a higher level of abstraction promotes learning which is more
      efficient and long lasting. The investigators will use neurocognitive tests and fMRI
      (explained above) before and after the 4-week period to detect any changes in participants'
      brain and/ or thinking processes.

      Post Intervention: Following the intervention, patients will repeat the cognitive
      neuropsychological assessment and fMRI identical to the pre-training assessment. Participants
      are not paid for any of these tests or training sessions.
    

Intervention name(s): Advanced Reasoning Training
Intervention type(s): Behavioral
Intervention description(s): This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Other intervention name(s): Gist Reasoning Training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care