NCT02168166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 4, 2018

Status Verified

April 1, 2018

Enrollment Period

3.1 years

First QC Date

June 16, 2014

Last Update Submit

April 2, 2018

Conditions

Keywords

Neurological DisordersNeuroscienceNeuropsychologyEEGCognitive remediationCognitive Response

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from baseline EEG theta-gamma frequency modulation at post-treatment assessment

    Pre-training assessment (Week 1) and post-training assessment (Week 4)

  • Change from baseline EEG alpha power at post-treatment assessment

    Pre-training assessment (Week 1) and post-training assessment (Week 4)

Study Arms (2)

Executive Function Training

ACTIVE COMPARATOR

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

Behavioral: Executive Function Training

Placebo Training

PLACEBO COMPARATOR

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

Interventions

Executive Function Training
PlaceboBEHAVIORAL

Placebo version of executive function training

Placebo Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L3N6, Canada

Location

MeSH Terms

Conditions

Psychotic DisordersNervous System Diseases

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Christopher Bowie, PhD, CPsych

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 20, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

April 4, 2018

Record last verified: 2018-04

Locations