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Reasoning Training in Individuals With Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843282
Recruitment Status : Unknown
Verified July 2016 by The University of Texas at Dallas.
Recruitment status was:  Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
The University of Texas at Dallas

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Cognitive Ability, General Behavioral: Advanced Reasoning Training Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Brain & Cognitive Changes After Reasoning Training in Individuals With Bipolar Disorder
Study Start Date : April 2014
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Cognitive training
Advanced reasoning training
Behavioral: 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.
Other Name: Gist Reasoning Training




Primary Outcome Measures :
  1. Change from Baseline: Test of Strategic Learning [ Time Frame: Pre and within 2 weeks post intervention ]
    Synthesize a complex text, abstract take away messages, answer detail probes.


Secondary Outcome Measures :
  1. Change from Baseline: Wechsler Adult Intelligence Scale (WAIS), Similarities subtest [ Time Frame: Pre and within 2 weeks post intervention ]
    Concept Formation

  2. Change from Baseline: DKEFS Card Sorting [ Time Frame: Pre and within 2 weeks post intervention ]
    Problem Solving & Concept Formation

  3. Change from Baseline: Digits Backwards [ Time Frame: Pre and within 2 weeks post intervention ]
    Working Memory

  4. Change from Baseline: DKEFS Color-Word [ Time Frame: Pre and within 2 weeks post intervention ]
    Inhibition & Switching

  5. Change from Baseline: Trails B [ Time Frame: Pre and within 2 weeks post intervention ]
    Switching

  6. Change from Baseline: COWAT [ Time Frame: Pre and within 2 weeks post intervention ]
    Verbal Fluency

  7. Change from Baseline: RAVLT [ Time Frame: Pre and within 2 weeks post intervention ]
    Memory

  8. Change from Baseline: Logical Memory [ Time Frame: Pre and within 2 weeks post intervention ]
    Memory

  9. Change from Baseline: Quality of Life in Bipolar Disorder (QoL.BD) [ Time Frame: Pre and within 2 weeks post intervention ]
    Quality of Life questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843282


Sponsors and Collaborators
The University of Texas at Dallas
University of Texas
Investigators
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Principal Investigator: Sandra Chapman, PhD University of Texas at Dallas
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT02843282    
Other Study ID Numbers: 14-16
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not at this time
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders