NCT02843282

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

December 6, 2024

Completed
Last Updated

December 6, 2024

Status Verified

October 1, 2024

Enrollment Period

1.4 years

First QC Date

July 14, 2016

Results QC Date

December 8, 2023

Last Update Submit

October 18, 2024

Conditions

Outcome Measures

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

    Pre and within 2 weeks post intervention

Secondary Outcomes (12)

  • Change From Baseline: Wechsler Adult Intelligence Scale (WAIS), Similarities Subtest

    Pre and within 2 weeks post intervention

  • Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Card Sorting

    Pre and within 2 weeks post intervention

  • Change From Baseline: Working Memory (Digits Backwards)

    Pre and within 2 weeks post intervention

  • Change From Baseline: Delis-Kaplan Executive Function System (DKEFS) Color-Word, Inhibition & Switching Subtest

    Pre and within 2 weeks post intervention

  • Change From Baseline: Divided Attention

    Pre and within 2 weeks post intervention

  • +7 more secondary outcomes

Study Arms (1)

Cognitive training

EXPERIMENTAL

Advanced reasoning training

Behavioral: Advanced Reasoning Training

Interventions

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

Also known as: Gist Reasoning Training
Cognitive training

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 26070195BACKGROUND
  • 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.

    PMID: 23717272BACKGROUND
  • 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.

    PMID: 19895584BACKGROUND
  • 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.

    PMID: 24808834BACKGROUND
  • 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.

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Results Point of Contact

Title
Erin Venza, Research Clinician
Organization
University of Texas at Dallas, Center for BrainHealth

Study Officials

  • Sandra Chapman, PhD

    The University of Texas at Dallas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 25, 2016

Study Start

April 1, 2014

Primary Completion

September 1, 2015

Study Completion

February 1, 2018

Last Updated

December 6, 2024

Results First Posted

December 6, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Not at this time