Clinical Trials Directory

Trials / Completed

CompletedNCT02843282

Reasoning Training in Individuals With Bipolar Disorder

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
27 (actual)
Sponsor
The University of Texas at Dallas · Academic / Other
Sex
All
Age
20 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAdvanced Reasoning TrainingThis is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.

Timeline

Start date
2014-04-01
Primary completion
2015-09-01
Completion
2018-02-01
First posted
2016-07-25
Last updated
2024-12-06
Results posted
2024-12-06

Source: ClinicalTrials.gov record NCT02843282. Inclusion in this directory is not an endorsement.