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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02168166
Other study ID # GPSYC-651-14
Secondary ID
Status Completed
Phase N/A
First received June 16, 2014
Last updated April 2, 2018
Start date May 2014
Est. completion date June 2017

Study information

Verified date April 2018
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Executive Function Training

Placebo
Placebo version of executive function training

Locations

Country Name City State
Canada Queen's University Kingston Ontario

Sponsors (1)

Lead Sponsor Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline executive functioning composite score at post-treatment assessment Composite score based on four tests of cognition Pre-training assessment (Week 1) and post-training assessment (Week 4)
Secondary 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 Pre-training assessment (Week 1) and post-training assessment (Week 4)
Secondary Change from baseline EEG alpha power at post-treatment assessment Predicted to increase in active CR (cognitive remediation) condition compared to placebo CR Pre-training assessment (Week 1) and post-training assessment (Week 4)
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