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| Name | Class |
|---|---|
| University of Texas | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive training | Experimental | Advanced reasoning training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced Reasoning Training | Behavioral | This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline: Test of Strategic Learning | 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] | Pre and within 2 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline: Wechsler Adult Intelligence Scale (WAIS), Similarities Subtest | Participants are provided with two words/concepts and must state how they are alike; [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Pre and within 2 weeks post intervention |
| Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Card Sorting |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Chapman, PhD | The University of Texas at Dallas | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26070195 | Background | 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. | |
| 23717272 | Background |
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Not at this time
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No enrolled participants were excluded from the training
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All baseline participants completed study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline: Test of Strategic Learning | 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] | Posted | Mean | Standard Error | score on a scale | Pre and within 2 weeks post intervention |
|
|
Baseline assessment to post assessment (2 weeks post intervention)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Venza, Research Clinician | University of Texas at Dallas, Center for BrainHealth | 972-883-3208 | erin.venza@utdallas.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 3, 2017 | Jun 14, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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Participants must sort a set of cards into as many groups as possible, based on certain parameters. This score reflects the correct number of sorts generated. [scaled scores, min value = 0, max value = 19, higher indicates better performance] |
| Pre and within 2 weeks post intervention |
| Change From Baseline: Working Memory (Digits Backwards) | Participants must recite number sequences in reverse order; [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Pre and within 2 weeks post intervention |
| Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Color-Word, Inhibition & Switching Subtest | Participants must either state color of word or read the word presented; [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Pre and within 2 weeks post intervention |
| Change From Baseline: Divided Attention | Participants connect letters and numbers in ascending order as quickly as they can; [raw score in seconds, min value = 0, max value = 200, lower indicates better performance] | Pre and within 2 weeks post intervention |
| Change From Baseline: Verbal Fluency | Participants had to generate as many words as possible in one minute that fit task parameters; [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Pre and within 2 weeks post intervention |
| Change From Baseline: Rey Auditory Verbal Learning Test (RAVLT) | Participants are asked to recall a list of words they heard 20 minutes earlier; [raw scores, min value = 0, max value = 15, higher indicates better performance] | Pre and within 2 weeks post intervention |
| Change From Baseline: Logical Memory | Participants are asked to recall the details of a story they were read 20 minutes earlier; [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Pre and within 2 weeks post intervention |
| Change From Baseline: Quality of Life in Bipolar Disorder (QoL.BD) | Participants fill out a self-report questionnaire assessing different domains of quality of life; [raw score; min value = 0, max value = 280, higher score indicates higher reported quality of life] | Pre and within 2 weeks post intervention |
| Resting State Relative Cerebral Brain Blood Flow (rCBF) | Mean-level change in resting state relative cerebral brain blood flow (rCBF) in left Inferior frontal gyrus (min value = 0, max value = 2, lower value indicates decreased cerebral blood flow and higher indicates increased cerebral blood flow) | Pre (from baseline) and within 2 weeks post intervention |
| Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Description of Sorts | Participants must sort a set of cards into as many groups as possible, based on certain parameters, and state why it is an accurate sort. This score reflects the accuracy of the sort description. [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Pre and within 2 weeks post intervention |
| Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Recognition of Sorts | After proctor has sorted cards, participants must state why sort is accurate/how cards are alike. [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Pre and within 2 weeks post intervention |
| 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. |
| 19895584 | Background | 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. |
| 24808834 | Background | 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. |
| 27847486 | Derived | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Change From Baseline: Wechsler Adult Intelligence Scale (WAIS), Similarities Subtest | Participants are provided with two words/concepts and must state how they are alike; [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Posted | Mean | Standard Error | score on a scale | Pre and within 2 weeks post intervention |
|
|
|
|
| Secondary | Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Card Sorting | Participants must sort a set of cards into as many groups as possible, based on certain parameters. This score reflects the correct number of sorts generated. [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Posted | Mean | Standard Error | score on a scale | Pre and within 2 weeks post intervention |
|
|
|
|
| Secondary | Change From Baseline: Working Memory (Digits Backwards) | Participants must recite number sequences in reverse order; [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Posted | Mean | Standard Error | score on a scale | Pre and within 2 weeks post intervention |
|
|
|
|
| Secondary | Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Color-Word, Inhibition & Switching Subtest | Participants must either state color of word or read the word presented; [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Posted | Mean | Standard Error | score on a scale | Pre and within 2 weeks post intervention |
|
|
|
|
| Secondary | Change From Baseline: Divided Attention | Participants connect letters and numbers in ascending order as quickly as they can; [raw score in seconds, min value = 0, max value = 200, lower indicates better performance] | Posted | Mean | Standard Error | seconds | Pre and within 2 weeks post intervention |
|
|
|
|
| Secondary | Change From Baseline: Verbal Fluency | Participants had to generate as many words as possible in one minute that fit task parameters; [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Posted | Mean | Standard Error | score on a scale | Pre and within 2 weeks post intervention |
|
|
|
|
| Secondary | Change From Baseline: Rey Auditory Verbal Learning Test (RAVLT) | Participants are asked to recall a list of words they heard 20 minutes earlier; [raw scores, min value = 0, max value = 15, higher indicates better performance] | Posted | Mean | Standard Error | score on a scale | Pre and within 2 weeks post intervention |
|
|
|
|
| Secondary | Change From Baseline: Logical Memory | Participants are asked to recall the details of a story they were read 20 minutes earlier; [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Posted | Mean | Standard Error | score on a scale | Pre and within 2 weeks post intervention |
|
|
|
|
| Secondary | Change From Baseline: Quality of Life in Bipolar Disorder (QoL.BD) | Participants fill out a self-report questionnaire assessing different domains of quality of life; [raw score; min value = 0, max value = 280, higher score indicates higher reported quality of life] | Posted | Mean | Standard Error | score on a scale | Pre and within 2 weeks post intervention |
|
|
|
|
| Secondary | Resting State Relative Cerebral Brain Blood Flow (rCBF) | Mean-level change in resting state relative cerebral brain blood flow (rCBF) in left Inferior frontal gyrus (min value = 0, max value = 2, lower value indicates decreased cerebral blood flow and higher indicates increased cerebral blood flow) | Only for participants who participated in brain imaging portion of study (only for participants that were eligible for MRI) | Posted | Mean | Standard Deviation | score on a scale | Pre (from baseline) and within 2 weeks post intervention |
|
|
|
|
| Secondary | Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Description of Sorts | Participants must sort a set of cards into as many groups as possible, based on certain parameters, and state why it is an accurate sort. This score reflects the accuracy of the sort description. [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Posted | Mean | Standard Error | score on a scale | Pre and within 2 weeks post intervention |
|
|
|
|
| Secondary | Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Recognition of Sorts | After proctor has sorted cards, participants must state why sort is accurate/how cards are alike. [scaled scores, min value = 0, max value = 19, higher indicates better performance] | Posted | Mean | Standard Error | score on a scale | Pre and within 2 weeks post intervention |
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| 0 |
| 27 |
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| 27 |
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