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A Comparison of Cognitive Training Approaches in Psychotic Disorders

Primary Purpose

Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Remediation - Executive Training
Cognitive Remediation - Perceptual Training
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Queen's University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Executive Training

Perceptual Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline
Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks

Secondary Outcome Measures

Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline
The MCCB is the gold standard cognitive assessment for schizophrenia research
Change in Neurophysiology - EEG from Baseline
Alpha and Theta band synchronization, p300, mismatch negativity
Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline
Performance based measure of real life functional skills using role-play
Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline
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
The MCCB is the gold standard cognitive assessment for schizophrenia research
Change in Neurophysiology - EEG from Baseline
Alpha and Theta band synchronization, p300, mismatch negativity
Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline
Performance based measure of real life functional skills using role-play

Full Information

First Posted
October 27, 2016
Last Updated
November 12, 2018
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT03024203
Brief Title
A Comparison of Cognitive Training Approaches in Psychotic Disorders
Official Title
A Comparison of Cognitive Training Approaches in Psychotic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Executive Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Perceptual Training
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Cognitive Remediation - Executive Training
Intervention Description
Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as memory, and problem solving ability.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation - Perceptual Training
Intervention Description
Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as attention, and processing speed.
Primary Outcome Measure Information:
Title
Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline
Description
Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks
Time Frame
Post-treatment (within 2 weeks following the end of treatment)
Secondary Outcome Measure Information:
Title
Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline
Description
The MCCB is the gold standard cognitive assessment for schizophrenia research
Time Frame
Post-treatment (within 2 weeks following the end of treatment)
Title
Change in Neurophysiology - EEG from Baseline
Description
Alpha and Theta band synchronization, p300, mismatch negativity
Time Frame
Post-treatment (within 2 weeks following the end of treatment)
Title
Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline
Description
Performance based measure of real life functional skills using role-play
Time Frame
Post-treatment (within 2 weeks following the end of treatment)
Title
Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline
Description
Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks
Time Frame
Follow-Up (3 months after the end of treatment)
Title
Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline
Description
The MCCB is the gold standard cognitive assessment for schizophrenia research
Time Frame
Follow-Up (3 months after the end of treatment)
Title
Change in Neurophysiology - EEG from Baseline
Description
Alpha and Theta band synchronization, p300, mismatch negativity
Time Frame
Follow-Up (3 months after the end of treatment)
Title
Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline
Description
Performance based measure of real life functional skills using role-play
Time Frame
Follow-Up (3 months after the end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: psychotic disorder No previous cognitive remediation in past 6 months Exclusion Criteria: Brain injury Substance abuse Neurocognitive disorder Developmental Disability
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30845819
Citation
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.
Results Reference
derived

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A Comparison of Cognitive Training Approaches in Psychotic Disorders

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