Reasoning Training in Individuals With Bipolar Disorder
NCT ID: NCT02843282
Last Updated: 2024-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2014-04-30
2018-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Cognitive training
Advanced reasoning training
Advanced Reasoning Training
This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
Interventions
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Advanced Reasoning Training
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 Names
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Eligibility Criteria
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Inclusion 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
* Less than 12 years education
* Additional psychiatric diagnosis
20 Years
70 Years
ALL
No
Sponsors
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University of Texas
OTHER
The University of Texas at Dallas
OTHER
Responsible Party
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Principal Investigators
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Sandra Chapman, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas at Dallas
References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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14-16
Identifier Type: -
Identifier Source: org_study_id