STExFx: Short-term Working Memory and Executive Training

Sponsor

Queen's University (Other)

Overall Status

Completed

CT.gov ID

NCT02168166

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorders	Behavioral: Executive Function Training Behavioral: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated 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 1, 2014

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline EEG theta-gamma frequency modulation at post-treatment assessment [Pre-training assessment (Week 1) and post-training assessment (Week 4)]
Predicted to improve in active CR (cognitive remediation) condition compared to placebo CR
Change from baseline EEG alpha power at post-treatment assessment [Pre-training assessment (Week 1) and post-training assessment (Week 4)]
Predicted to increase in active CR (cognitive remediation) condition compared to placebo CR

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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