跳至主要内容
临床试验/NCT02843282
NCT02843282
已完成
不适用

Brain & Cognitive Changes After Reasoning Training in Individuals With Bipolar Disorder

The University of Texas at Dallas0 个研究点目标入组 27 人2014年4月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Bipolar Disorder
发起方
The University of Texas at Dallas
入组人数
27
主要终点
Change From Baseline: Test of Strategic Learning
状态
已完成
最后更新
去年

概览

简要总结

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.

详细描述

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. Functional magnetic resonance imaging (fMRI): 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. 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. 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.

注册库
clinicaltrials.gov
开始日期
2014年4月
结束日期
2018年2月
最后更新
去年
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Change From Baseline: Test of Strategic Learning

时间窗: 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). \[raw scores, min value = 0, max value = 10, higher indicates better performance\]

次要结局

  • 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)

相似试验