Short-term Working Memory and Executive Training (STExFx)

April 2, 2018 updated by: Dr. Christopher Bowie, Queen's University

Short-Term Executive Functioning Training

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L3N6
        • Queen's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-training assessment (Week 1) and post-training assessment (Week 4)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-training assessment (Week 1) and post-training assessment (Week 4)
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
Pre-training assessment (Week 1) and post-training assessment (Week 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: Christopher Bowie, PhD, CPsych, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

June 16, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (Estimate)

June 20, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPSYC-651-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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