A Comparison of Cognitive Training Approaches in Psychotic Disorders

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

Tracking Information

• First Submitted Date: October 27, 2016
• First Posted Date: January 18, 2017
• Last Update Posted Date: November 14, 2018
• Actual Study Start Date: August 2016
• Actual Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Comparison of Cognitive Training Approaches in Psychotic Disorders
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Psychotic Disorders

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 12, 2018): 70
• Original Estimated Enrollment (submitted: January 15, 2017): 60
• Actual Study Completion Date: March 2018
• Actual Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03024203
• Other Study ID Numbers: PSYC-173-16
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dr. Christopher Bowie, Queen's University
• Original Responsible Party: Same as current
• Current Study Sponsor: Queen's University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Queen's University
• Verification Date: November 2018