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Short-term Working Memory and Executive Training (STExFx)

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: NCT02168166
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Christopher Bowie, Queen's University

Brief Summary:
Cognitive remediation (CR) therapies refer to a number of recent developments to use behavioural strategies to improve neurocognitive abilities and improve everyday functioning in mental disorders such as schizophrenia, bipolar disorder, and depression. In this study, we aim to examine whether we can observe CR effects on measures of neuroplasticity, cognition, and functioning when using a rigorous control comparison group. We hypothesize that the active group will exhibit improvements in executive functioning composite scores, improved EEG theta-gamma frequency modulation, and increased EEG alpha power compared to the placebo group.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Behavioral: Executive Function Training Behavioral: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Short-Term Executive Functioning Training
Study Start Date : May 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Executive Function Training

Two weeks of training of cognitive domain of executive functioning

Using online program (Scientific Brain Training Pro)

Four exercises

Behavioral: Executive Function Training
Placebo Comparator: Placebo Training

Two weeks of training with exercises not affecting working memory, information processing speed, or cognitive load

Exercises maintain other traditional progressive aspects to preserve appearance of dynamic titration of difficulty levels

Using online program (Scientific Brain Training Pro)

Four exercises

Behavioral: Placebo
Placebo version of executive function training




Primary Outcome Measures :
  1. Change from baseline executive functioning composite score at post-treatment assessment [ Time Frame: Pre-training assessment (Week 1) and post-training assessment (Week 4) ]
    Composite score based on four tests of cognition


Secondary Outcome Measures :
  1. Change from baseline EEG theta-gamma frequency modulation at post-treatment assessment [ Time Frame: Pre-training assessment (Week 1) and post-training assessment (Week 4) ]
    Predicted to improve in active CR (cognitive remediation) condition compared to placebo CR

  2. Change from baseline EEG alpha power at post-treatment assessment [ Time Frame: Pre-training assessment (Week 1) and post-training assessment (Week 4) ]
    Predicted to increase in active CR (cognitive remediation) condition compared to placebo CR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of a chronic mental disorder (defined herein as bipolar disorder, major depressive disorder, or a schizophrenia-spectrum disorder)
  • between the ages of 18 and 65
  • speak and read fluent English
  • able to use a computer

Exclusion Criteria:

  • active substance abuse or dependence diagnosis
  • sensory or motor issues that would preclude completion of study procedures
  • enrollment in a cognitive remediation program or use of cognitive training programs (e.g. lumosity.com) within the past 6 months

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): NCT02168166


Locations
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Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L3N6
Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: Christopher Bowie, PhD, CPsych Queen's University
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Responsible Party: Dr. Christopher Bowie, Dr., Queen's University
ClinicalTrials.gov Identifier: NCT02168166    
Other Study ID Numbers: GPSYC-651-14
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Keywords provided by Dr. Christopher Bowie, Queen's University:
Neurological Disorders
Neuroscience
Neuropsychology
EEG
Cognitive remediation
Cognitive Response
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders