AzTrials
AzTrials

Bipolar DisorderNCT02843282

Reasoning Training in Individuals With Bipolar Disorder

A study testing Advanced Reasoning Training in people with Bipolar Disorder and Cognitive Ability, General, run by The University of Texas at Dallas.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Bipolar Disorder, Cognitive Ability, General
What is being tested?
Advanced Reasoning Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
No sites listed yet
Study dates
Apr 2014to Feb 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Not a native English speaker
  • Less than 12 years education
  • Additional psychiatric diagnosis

About this study

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

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.

Read the 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.

Being tested
Advanced Reasoning Training
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advanced Reasoning TrainingBehavioural

    Also called 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.

Study groups in NCT02843282
Study groupRoleWhat they receive
Cognitive trainingExperimentalAdvanced reasoning training
Receives: Behavioral: Advanced Reasoning Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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]

    Measured: Pre and within 2 weeks post intervention

Secondary outcomes (12)

  1. 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]

    Measured: Pre and within 2 weeks post intervention

  2. 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]

    Measured: Pre and within 2 weeks post intervention

  3. 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]

    Measured: Pre and within 2 weeks post intervention

  4. 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]

    Measured: Pre and within 2 weeks post intervention

  5. 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]

    Measured: Pre and within 2 weeks post intervention

  6. 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]

    Measured: Pre and within 2 weeks post intervention

  7. 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]

    Measured: Pre and within 2 weeks post intervention

  8. 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]

    Measured: Pre and within 2 weeks post intervention

  9. 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]

    Measured: Pre and within 2 weeks post intervention

  10. 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)

    Measured: Pre (from baseline) and within 2 weeks post intervention

  11. 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]

    Measured: Pre and within 2 weeks post intervention

  12. 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]

    Measured: Pre and within 2 weeks post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2016 (estimated)
  2. Study startApr 2014
  3. Primary completionSep 2015
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02843282
Sponsor's protocol ID
14-16
Status last verified
Oct 2024
First submitted
14 Jul 2016
Last updated
6 Dec 2024
Data monitoring committee
No
Individual data sharing
No: Not at this time

Publications

  • 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.

    PubMed 26070195

  • 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.

    PubMed 23717272

  • 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.

    PubMed 19895584

  • 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.

    PubMed 24808834

  • 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.

    PubMed 27847486

Questions about this trial

What is this clinical trial studying?

A study testing Advanced Reasoning Training in people with Bipolar Disorder and Cognitive Ability, General, run by The University of Texas at Dallas.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline: Test of Strategic Learning (time frame: Pre and within 2 weeks post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02843282, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT02843282 | AzTrials