Clinical trial NCT02843282: Reasoning Training in Individuals With Bipolar Disorder
Official title: Brain & Cognitive Changes After Reasoning Training in Individuals With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Cognitive Ability, General
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
Collaborators: name: University of Texas
First posted: 2016-07-25
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Must have physician or psychiatrist authorization form confirming participant fulfills 4 criteria:

  1. has diagnosis of Bipolar I or II
  2. has been stable and consistent with medication for last 3 months
  3. is in a euthymic, rather than manic or depressive, state
  4. is appropriate for a group-based intervention

     EXCLUSION CRITERIA:
* Not a native English speaker
* Less than 12 years education
* Additional psychiatric diagnosis

Primary outcomes:
measure: Change From Baseline: Test of Strategic Learning
timeFrame: Pre and within 2 weeks post intervention
Secondary outcomes:
measure: Change From Baseline: Wechsler Adult Intelligence Scale (WAIS), Similarities Subtest
timeFrame: Pre and within 2 weeks post intervention
measure: Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Card Sorting
timeFrame: Pre and within 2 weeks post intervention
measure: Change From Baseline: Working Memory (Digits Backwards)
timeFrame: Pre and within 2 weeks post intervention
measure: Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Color-Word, Inhibition & Switching Subtest
timeFrame: Pre and within 2 weeks post intervention
measure: Change From Baseline: Divided Attention
timeFrame: Pre and within 2 weeks post intervention
measure: Change From Baseline: Verbal Fluency
timeFrame: Pre and within 2 weeks post intervention
measure: Change From Baseline: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Pre and within 2 weeks post intervention
measure: Change From Baseline: Logical Memory
timeFrame: Pre and within 2 weeks post intervention
measure: Change From Baseline: Quality of Life in Bipolar Disorder (QoL.BD)
timeFrame: Pre and within 2 weeks post intervention
measure: Resting State Relative Cerebral Brain Blood Flow (rCBF)
timeFrame: Pre (from baseline) and within 2 weeks post intervention
measure: Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Description of Sorts
timeFrame: Pre and within 2 weeks post intervention
measure: Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Recognition of Sorts
timeFrame: Pre and within 2 weeks post intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas at Dallas
name: Sandra Chapman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Demant KM, Vinberg M, Kessing LV, Miskowiak KW. Effects of Short-Term Cognitive Remediation on Cognitive Dysfunction in Partially or Fully Remitted Individuals with Bipolar Disorder: Results of a Randomised Controlled Trial. PLoS One. 2015 Jun 12;10(6):e0127955. doi: 10.1371/journal.pone.0127955. eCollection 2015.
citation: Preiss M, Shatil E, Cermakova R, Cimermanova D, Ram I. Personalized cognitive training in unipolar and bipolar disorder: a study of cognitive functioning. Front Hum Neurosci. 2013 May 13;7:108. doi: 10.3389/fnhum.2013.00108. eCollection 2013.
citation: Deckersbach T, Nierenberg AA, Kessler R, Lund HG, Ametrano RM, Sachs G, Rauch SL, Dougherty D. RESEARCH: Cognitive rehabilitation for bipolar disorder: An open trial for employed patients with residual depressive symptoms. CNS Neurosci Ther. 2010 Oct;16(5):298-307. doi: 10.1111/j.1755-5949.2009.00110.x.
citation: Chapman SB, Mudar RA. Enhancement of cognitive and neural functions through complex reasoning training: evidence from normal and clinical populations. Front Syst Neurosci. 2014 Apr 28;8:69. doi: 10.3389/fnsys.2014.00069. eCollection 2014.
citation: Venza EE, Chapman SB, Aslan S, Zientz JE, Tyler DL, Spence JS. Enhancing Executive Function and Neural Health in Bipolar Disorder through Reasoning Training. Front Psychol. 2016 Nov 1;7:1676. doi: 10.3389/fpsyg.2016.01676. eCollection 2016.