Overview

This trial is active, not recruiting.

Conditions bipolar disorder, cognitive ability, general
Treatment advanced reasoning training
Phase phase 1
Sponsor The University of Texas at Dallas
Collaborator University of Texas
Start date April 2014
End date September 2015
Trial size 27 participants
Trial identifier NCT02843282, 14-16

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Advanced reasoning training
advanced reasoning training Gist 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.

Primary Outcomes

Measure
Change from Baseline: Test of Strategic Learning
time frame: Pre and within 2 weeks post intervention

Secondary Outcomes

Measure
Change from Baseline: Wechsler Adult Intelligence Scale (WAIS), Similarities subtest
time frame: Pre and within 2 weeks post intervention
Change from Baseline: DKEFS Card Sorting
time frame: Pre and within 2 weeks post intervention
Change from Baseline: Digits Backwards
time frame: Pre and within 2 weeks post intervention
Change from Baseline: DKEFS Color-Word
time frame: Pre and within 2 weeks post intervention
Change from Baseline: Trails B
time frame: Pre and within 2 weeks post intervention
Change from Baseline: COWAT
time frame: Pre and within 2 weeks post intervention
Change from Baseline: RAVLT
time frame: Pre and within 2 weeks post intervention
Change from Baseline: Logical Memory
time frame: Pre and within 2 weeks post intervention
Change from Baseline: Quality of Life in Bipolar Disorder (QoL.BD)
time frame: Pre and within 2 weeks post intervention

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

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

Additional Information

Official title Brain & Cognitive Changes After Reasoning Training in Individuals With Bipolar Disorder
Principal investigator Sandra Chapman, PhD
Description The experiment will be undertaken with the understanding and written consent of each subject. 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. Additionally, two separate neuropsychological cognitive testing and two functional magnetic resonance imaging (fMRI) imaging procedures will be conducted with each participant: one at baseline prior to cognitive training, the second at the end of cognitive training (4 weeks). These testing procedures are explained below. Each participant will receive an appoint card/schedule of appointments to help them keep track of what is expected of them. During the training program participants will make 1 visit per week for 2 hours each over a 4-week period. Prior to cognitive training, participants' baseline gist and detail processing ability, battery of cognitive functions and neuropsychological measures will be obtained with a battery of cognitive measures. Structural and functional brain measures will also be obtained. All measurements will be taken again at the endpoint of training. 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. Given that the participant meets the requirements covered by the phone screen, participants will be asked to complete further screening. 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. The testing will be done at the Center for BrainHealth at 2200 W. Mockingbird Lane, Dallas, Texas. At the cognitive testing session, participants will sign a release form, and clinicians will fax both the release and 'approval form' to the physician. The neuropsychological cognitive test battery will include tests like Delis-Kaplan Executive Function System (DKEFS) Color-Word Interference Test, Delis-Kaplan Executive Function System (DKEFS) Card Sorting Test, Test of Strategic Learning (TOSL), Auditory Selective Learning, Wechsler Memory Scale (WMS-III) Logical Memory Subtest, Verbal Problem Solving, Wechsler Adult Intelligence Scale (WAIS) Similarities Subtest, Rey-Osterrieth Auditory Verbal Learning Test (RAVLT), Trails A, Trails B, the Controlled Order Word Association Test (COWAT), Wechsler Memory Scale (WMS-III) Digits forward and backwards, and Framing task. Functional magnetic resonance imaging (fMRI): On separate days, the 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. Participants may also receive training individually and through online training sessions instead of in a group setting. 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. Potentially, the learned strategies could be applied across a variety of living contexts such as attending lectures, going to the movies, following news stories, planning and carrying out a project, and understanding brochures outlining changes in health care benefits, to name a few. The strategy instruction is hierarchical and dynamically interdependent, with each strategy building upon previous strategies to transform the concrete meaning into abstracted gist-based meanings through reasoning and inference. Constructing meaning at a higher level of abstraction promotes learning which is more efficient and long lasting. The investigators will use neurocognitive tests and fMRI (explained above) before and after the 4-week period to detect any changes in participants' brain and/ or thinking processes. 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by The University of Texas at Dallas.