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A Comparison of Cognitive Training Approaches in Psychotic Disorders

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ClinicalTrials.gov Identifier: NCT03024203
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Christopher Bowie, Queen's University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Behavioral: Cognitive Remediation - Executive Training Behavioral: Cognitive Remediation - Perceptual Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Cognitive Training Approaches in Psychotic Disorders
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024203


Contacts
Contact: Michael W Best, M.Sc 1-877-669-8510 ext 105 best.m@queensu.ca
Contact: Christopher R Bowie, PhD 613-533-3347 bowiec@queensu.ca

Locations
Canada, Ontario
Queen's University Recruiting
Kingston, Ontario, Canada, K7L 5P6
Contact: Michael W Best, MSc    1-877-669-8510 ext 105    best.m@queensu.ca   
Contact: Christopher R Bowie, PhD    613-533-3347    bowiec@queensu.ca   
Sponsors and Collaborators
Queen's University

Responsible Party: Dr. Christopher Bowie, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT03024203     History of Changes
Other Study ID Numbers: PSYC-173-16
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders