Brain & Cognitive Changes After Reasoning Training in Individuals With Bipolar Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 27
- Primary Endpoint
- Change From Baseline: Test of Strategic Learning
Study Overview
Brief 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
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.
Participants will complete baseline cognitive testing. Reasoning training will take place in small groups, once a week for 2hr/session. After the training, participants will complete the cognitive testing again. A subset of participants who qualify for the brain imaging component will also complete a pre-post resting state brain scan.
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must have physician or psychiatrist authorization form confirming participant fulfills 4 criteria:
- •has diagnosis of Bipolar I or II
- •has been stable and consistent with medication for last 3 months
- •is in a euthymic, rather than manic or depressive, state
- •is appropriate for a group-based intervention
Exclusion Criteria
- •Not a native English speaker
- •Less than 12 years education
- •Additional psychiatric diagnosis
Arms & Interventions
Cognitive training
Advanced reasoning training
Intervention: Advanced Reasoning Training (Behavioral)
Outcomes
Primary Outcomes
Change From Baseline: Test of Strategic Learning
Time Frame: Pre and within 2 weeks post intervention
Complex abstraction subtest: After reading a complex text, participants generate a high-level synthesis of abstracted ideas (versus recall of concrete details). \[raw scores, min value = 0, max value = 10, higher indicates better performance\]
Secondary Outcomes
- Change From Baseline: Wechsler Adult Intelligence Scale (WAIS), Similarities Subtest(Pre and within 2 weeks post intervention)
- Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Card Sorting(Pre and within 2 weeks post intervention)
- Change From Baseline: Working Memory (Digits Backwards)(Pre and within 2 weeks post intervention)
- Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Color-Word, Inhibition & Switching Subtest(Pre and within 2 weeks post intervention)
- Change From Baseline: Divided Attention(Pre and within 2 weeks post intervention)
- Change From Baseline: Verbal Fluency(Pre and within 2 weeks post intervention)
- Change From Baseline: Rey Auditory Verbal Learning Test (RAVLT)(Pre and within 2 weeks post intervention)
- Change From Baseline: Logical Memory(Pre and within 2 weeks post intervention)
- Change From Baseline: Quality of Life in Bipolar Disorder (QoL.BD)(Pre and within 2 weeks post intervention)
- Resting State Relative Cerebral Brain Blood Flow (rCBF)(Pre (from baseline) and within 2 weeks post intervention)
- Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Description of Sorts(Pre and within 2 weeks post intervention)
- Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Recognition of Sorts(Pre and within 2 weeks post intervention)