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Short-term Working Memory and Executive Training (STExFx)

Primary Purpose

Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Executive Function Training
Placebo
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Neurological Disorders, Neuroscience, Neuropsychology, EEG, Cognitive remediation, Cognitive Response

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen's University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Executive Function Training

Placebo Training

Arm Description

Two weeks of training of cognitive domain of executive functioning Using online program (Scientific Brain Training Pro) Four exercises

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

Outcomes

Primary Outcome Measures

Change from baseline executive functioning composite score at post-treatment assessment
Composite score based on four tests of cognition

Secondary Outcome Measures

Change from baseline EEG theta-gamma frequency modulation at post-treatment assessment
Predicted to improve in active CR (cognitive remediation) condition compared to placebo CR
Change from baseline EEG alpha power at post-treatment assessment
Predicted to increase in active CR (cognitive remediation) condition compared to placebo CR

Full Information

First Posted
June 16, 2014
Last Updated
April 2, 2018
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT02168166
Brief Title
Short-term Working Memory and Executive Training
Acronym
STExFx
Official Title
Short-Term Executive Functioning Training
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
Neurological Disorders, Neuroscience, Neuropsychology, EEG, Cognitive remediation, Cognitive Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Executive Function Training
Arm Type
Active Comparator
Arm Description
Two weeks of training of cognitive domain of executive functioning Using online program (Scientific Brain Training Pro) Four exercises
Arm Title
Placebo Training
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Executive Function Training
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
Placebo version of executive function training
Primary Outcome Measure Information:
Title
Change from baseline executive functioning composite score at post-treatment assessment
Description
Composite score based on four tests of cognition
Time Frame
Pre-training assessment (Week 1) and post-training assessment (Week 4)
Secondary Outcome Measure Information:
Title
Change from baseline EEG theta-gamma frequency modulation at post-treatment assessment
Description
Predicted to improve in active CR (cognitive remediation) condition compared to placebo CR
Time Frame
Pre-training assessment (Week 1) and post-training assessment (Week 4)
Title
Change from baseline EEG alpha power at post-treatment assessment
Description
Predicted to increase in active CR (cognitive remediation) condition compared to placebo CR
Time Frame
Pre-training assessment (Week 1) and post-training assessment (Week 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Bowie, PhD, CPsych
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L3N6
Country
Canada

12. IPD Sharing Statement

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Short-term Working Memory and Executive Training

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