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A Comparison of Cognitive Training Approaches in Psychotic Disorders

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ClinicalTrials.gov Identifier: NCT03024203
Recruitment Status : Completed
First Posted : January 18, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Christopher Bowie, Queen's University

Tracking Information
First Submitted Date  ICMJE October 27, 2016
First Posted Date  ICMJE January 18, 2017
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Cognitive Training Approaches in Psychotic Disorders
Official Title  ICMJE A Comparison of Cognitive Training Approaches in Psychotic Disorders
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psychotic Disorders
Intervention  ICMJE
  • 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.
  • Behavioral: Cognitive Remediation - Perceptual Training
    Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as attention, and processing speed.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Cognitive Remediation - Executive Training
  • 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.
    Intervention: Behavioral: Cognitive Remediation - Perceptual Training
Publications * Best MW, Milanovic M, Iftene F, Bowie CR. A Randomized Controlled Trial of Executive Functioning Training Compared With Perceptual Training for Schizophrenia Spectrum Disorders: Effects on Neurophysiology, Neurocognition, and Functioning. Am J Psychiatry. 2019 Apr 1;176(4):297-306. doi: 10.1176/appi.ajp.2018.18070849. Epub 2019 Mar 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2018)
70
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2017)
60
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Brain injury
  • Substance abuse
  • Neurocognitive disorder
  • Developmental Disability
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03024203
Other Study ID Numbers  ICMJE PSYC-173-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Christopher Bowie, Queen's University
Study Sponsor  ICMJE Queen's University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Queen's University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP