Reasoning Training in Individuals With Bipolar Disorder

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02843282

Enrollment

Registered

2016-07-25

Start date

2014-04-30

Completion date

2018-02-28

Last updated

2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Cognitive Ability, General

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.

Interventions

BEHAVIORALAdvanced 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline: Test of Strategic Learning	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). \[raw scores, min value = 0, max value = 10, higher indicates better performance\]

Secondary

Measure	Time frame	Description
Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Card Sorting	Pre and within 2 weeks post intervention	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. \[scaled scores, min value = 0, max value = 19, higher indicates better performance\]
Change From Baseline: Working Memory (Digits Backwards)	Pre and within 2 weeks post intervention	Participants must recite number sequences in reverse order; \[scaled scores, min value = 0, max value = 19, higher indicates better performance\]
Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Color-Word, Inhibition & Switching Subtest	Pre and within 2 weeks post intervention	Participants must either state color of word or read the word presented; \[scaled scores, min value = 0, max value = 19, higher indicates better performance\]
Change From Baseline: Divided Attention	Pre and within 2 weeks post intervention	Participants connect letters and numbers in ascending order as quickly as they can; \[raw score in seconds, min value = 0, max value = 200, lower indicates better performance\]
Change From Baseline: Verbal Fluency	Pre and within 2 weeks post intervention	Participants had to generate as many words as possible in one minute that fit task parameters; \[scaled scores, min value = 0, max value = 19, higher indicates better performance\]
Change From Baseline: Wechsler Adult Intelligence Scale (WAIS), Similarities Subtest	Pre and within 2 weeks post intervention	Participants are provided with two words/concepts and must state how they are alike; \[scaled scores, min value = 0, max value = 19, higher indicates better performance\]
Change From Baseline: Logical Memory	Pre and within 2 weeks post intervention	Participants are asked to recall the details of a story they were read 20 minutes earlier; \[scaled scores, min value = 0, max value = 19, higher indicates better performance\]
Change From Baseline: Quality of Life in Bipolar Disorder (QoL.BD)	Pre and within 2 weeks post intervention	Participants fill out a self-report questionnaire assessing different domains of quality of life; \[raw score; min value = 0, max value = 280, higher score indicates higher reported quality of life\]
Resting State Relative Cerebral Brain Blood Flow (rCBF)	Pre (from baseline) and within 2 weeks post intervention	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)
Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Description of Sorts	Pre and within 2 weeks post intervention	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. \[scaled scores, min value = 0, max value = 19, higher indicates better performance\]
Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Accurate Recognition of Sorts	Pre and within 2 weeks post intervention	After proctor has sorted cards, participants must state why sort is accurate/how cards are alike. \[scaled scores, min value = 0, max value = 19, higher indicates better performance\]
Change From Baseline: Rey Auditory Verbal Learning Test (RAVLT)	Pre and within 2 weeks post intervention	Participants are asked to recall a list of words they heard 20 minutes earlier; \[raw scores, min value = 0, max value = 15, higher indicates better performance\]

Participant flow

Pre-assignment details

No enrolled participants were excluded from the training

Participants by arm

Arm	Count
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.	27
Total	27

Baseline characteristics

Characteristic	Cognitive Training
Age, Continuous	45.8 years STANDARD_DEVIATION 12.9
Sex: Female, Male Female	16 Participants
Sex: Female, Male Male	11 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 27
other Total, other adverse events	0 / 27
serious Total, serious adverse events	0 / 27

Outcome results

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