A Comparison of Cognitive Training Approaches in Psychotic Disorders

November 12, 2018 updated by: Dr. Christopher Bowie, Queen's University
Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for individuals with psychosis, however, there is no gold standard method of cognitive remediation available. Cognitive training refers to the training component of CR in which people practice computerized exercises that train specific cognitive abilities. There is no agreed upon approach within the field as to the type of training that is most effective with some studies, training higher level cognitive abilities, some training perceptual abilities, and others training general cognitive skills. This study will directly compare two competing methods of cognitive training on measures of neurophysiology, neurocognition, functional competence, and real-world functional performance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

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, K7L 5P6
        • 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:

  • psychotic disorder
  • No previous cognitive remediation in past 6 months

Exclusion Criteria:

  • Brain injury
  • Substance abuse
  • Neurocognitive disorder
  • Developmental Disability

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Executive Training
Executive Training (ET) involves training on computerized cognitive exercises that have graded increases in difficulty so that the participant is always challenged. A therapist will be in the room with participants to address any difficulties with the program and facilitate generation of strategies. ET will be delivered in both individual and group settings.
Behavioral: Cognitive Remediation - Executive Training
Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as memory, and problem solving ability.
Experimental: Perceptual Training
Perceptual Training (PT) involves training on computerized cognitive exercises that have graded increases in difficulty so that the participant is always challenged. A therapist will be in the room with participants to address any difficulties with the program and facilitate generation of strategies. PT will be delivered in both individual and group settings.
Behavioral: Cognitive Remediation - Perceptual Training
Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as attention, and processing speed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline
Time Frame: Post-treatment (within 2 weeks following the end of treatment)
Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks
Post-treatment (within 2 weeks following the end of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline
Time Frame: Post-treatment (within 2 weeks following the end of treatment)
The MCCB is the gold standard cognitive assessment for schizophrenia research
Post-treatment (within 2 weeks following the end of treatment)
Change in Neurophysiology - EEG from Baseline
Time Frame: Post-treatment (within 2 weeks following the end of treatment)
Alpha and Theta band synchronization, p300, mismatch negativity
Post-treatment (within 2 weeks following the end of treatment)
Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline
Time Frame: Post-treatment (within 2 weeks following the end of treatment)
Performance based measure of real life functional skills using role-play
Post-treatment (within 2 weeks following the end of treatment)
Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline
Time Frame: Follow-Up (3 months after the end of treatment)
Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks
Follow-Up (3 months after the end of treatment)
Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline
Time Frame: Follow-Up (3 months after the end of treatment)
The MCCB is the gold standard cognitive assessment for schizophrenia research
Follow-Up (3 months after the end of treatment)
Change in Neurophysiology - EEG from Baseline
Time Frame: Follow-Up (3 months after the end of treatment)
Alpha and Theta band synchronization, p300, mismatch negativity
Follow-Up (3 months after the end of treatment)
Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline
Time Frame: Follow-Up (3 months after the end of treatment)
Performance based measure of real life functional skills using role-play
Follow-Up (3 months after the end of treatment)

Collaborators and Investigators

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

Sponsor

Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

January 15, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSYC-173-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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