NCT03024203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

1.6 years

First QC Date

October 27, 2016

Last Update Submit

November 12, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Post-treatment (within 2 weeks following the end of treatment)

Secondary Outcomes (7)

  • Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline

    Post-treatment (within 2 weeks following the end of treatment)

  • Change in Neurophysiology - EEG from Baseline

    Post-treatment (within 2 weeks following the end of treatment)

  • Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline

    Post-treatment (within 2 weeks following the end of treatment)

  • Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline

    Follow-Up (3 months after the end of treatment)

  • Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline

    Follow-Up (3 months after the end of treatment)

  • +2 more secondary outcomes

Study Arms (2)

Executive Training

EXPERIMENTAL

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

Perceptual Training

EXPERIMENTAL

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

Interventions

Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as memory, and problem solving ability.

Executive Training

Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as attention, and processing speed.

Perceptual Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 5P6, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 27, 2016

First Posted

January 18, 2017

Study Start

August 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations