Examining Strategy Monitoring and Remediation Training

NCT04756388 | Completed

• 1 other identifier: 39698
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Executive Function Training is a cognitive training approach that specifically trains executive functioning for people with schizophrenia-spectrum disorders. The current study compares full executive function training to computerized training alone and to strategy monitoring alone.

Conditions

Psychotic Disorders; Executive Dysfunction

Keywords

psychosis; schizophrenia; cognitive remediation; executive functioning; strategy monitoring; computerized practice; cognitive training

Outcome Measures

Primary Outcomes (1)

• Specific Levels of Functioning Scale

  The SLOF is a behavioral questionnaire assessing community functioning. It includes 43 items, grouped into six subscales: Physical functioning; Personal care skills; Interpersonal relationships; Social acceptability; Activities of community living; and Work skills. Each of the 43 questions in the above subscales is rated on a 5-point Likert scale (1 = poorest function, 5 = best function) with anchors describing the frequency of the behavior and/or patient's level of independence. The higher the total score, the better the overall functioning of the individual. Scores range from 43 - 215.

  Change from Baseline to 12-Week Follow-up

Secondary Outcomes (12)

• Cambridge Neuropsychological Test Automated Battery (CANTAB)

  Change from Baseline to 12-Week Follow-up

• Wide Range Achievement Test (WRAT)

  Change from Baseline to 12-Week Follow-up

• Questionnaire About the Process of Recovery (QPR)

  Change from Baseline to 12-Week Follow-up

• Brief Psychiatric Rating Scale (BPRS)

  Change from Baseline to 12-Week Follow-up

• Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

  Change from Baseline to 12-Week Follow-up

Study Arms (3)

Executive Training

ACTIVE COMPARATOR

The Executive Training (ET) condition will consist of the ET intervention that Dr. Best previously developed and evaluated. ET sessions consist of 50% of the session practicing computerized cognitive training exercises, and 50% of the session developing cognitive strategies to use in the computerized exercises. Participants are encouraged to complete 40 minutes of computerized training per day, and complete strategy worksheets, at home between sessions. All interventions will be delivered virtually in the participant's home and group sessions will be conducted using the online platform Zoom.

Other: Strategy Development; Other: Computerized Cognitive Training

Strategy Development only

EXPERIMENTAL

In Strategy Development only participants will engage in cognitive strategy discussions to develop new executive function strategies that can be used in daily life. Between sessions, participants will be encouraged to practice their cognitive strategies in their daily life and track their strategies using the strategy worksheet. There will be no computerized cognitive training in this condition. All interventions will be delivered virtually in the participant's home and group sessions will be conducted using the online platform Zoom.

Other: Strategy Development

Computerized Cognitive Training only

EXPERIMENTAL

In Computerized Cognitive Training only participants will spend the entire one-hour session practicing computerized training exercises. Between sessions participants will be encouraged to practice the computerized exercises at home for 40 minutes per day. There will be no strategy development in this condition. All interventions will be delivered virtually in the participant's home and group sessions will be conducted using the online platform Zoom.

Other: Computerized Cognitive Training

Interventions

Strategy Development OTHER

Participants engage in cognitive strategy discussions to develop new executive function strategies that can be used in daily life, and track their strategies between sessions. No computerized cognitive training.

Executive Training; Strategy Development only

Computerized Cognitive Training OTHER

Participants practice computerized training exercises targeting executive functioning skills, and complete computerized exercises between sessions.

Computerized Cognitive Training only; Executive Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of schizophrenia, schizoaffective disorder or any other psychotic disorder (based on DSM-V)
• years of age
• know how to use a computer
• not abusing drugs or alcohol
• can read and speak English.

You may not qualify if:

• enrolled in a cognitive training program in the last 6 months
• neurological disease or neurological damage
• medical illnesses that can change neurocognitive function
• medical history of head injury with loss of consciousness
• physical handicaps

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

University of Toronto Scarborough

Toronto, Ontario, M1C 1A4, Canada

Location

Related Publications (21)

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  PMID: 20439824 BACKGROUND

• Subramaniam K, Luks TL, Fisher M, Simpson GV, Nagarajan S, Vinogradov S. Computerized cognitive training restores neural activity within the reality monitoring network in schizophrenia. Neuron. 2012 Feb 23;73(4):842-53. doi: 10.1016/j.neuron.2011.12.024.

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• 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.

  PMID: 30845819 BACKGROUND

• Best MW, Gale D, Tran T, Haque MK, Bowie CR. Brief executive function training for individuals with severe mental illness: Effects on EEG synchronization and executive functioning. Schizophr Res. 2019 Jan;203:32-40. doi: 10.1016/j.schres.2017.08.052. Epub 2017 Sep 19.

  PMID: 28931460 BACKGROUND

• Wykes T, Spaulding WD. Thinking about the future cognitive remediation therapy--what works and could we do better? Schizophr Bull. 2011 Sep;37 Suppl 2(Suppl 2):S80-90. doi: 10.1093/schbul/sbr064.

  PMID: 21860051 BACKGROUND

• Best MW, Bowie CR. A review of cognitive remediation approaches for schizophrenia: from top-down to bottom-up, brain training to psychotherapy. Expert Rev Neurother. 2017 Jul;17(7):713-723. doi: 10.1080/14737175.2017.1331128. Epub 2017 May 24.

  PMID: 28511562 BACKGROUND

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• Neil ST, Kilbride M, Pitt L, Nothard S, Welford M, Sellwood W, Morrison AP. The questionnaire about the process of recovery (QPR): A measurement tool developed in collaboration with service users. Psychosis. 2009; 1(2): 145-155.

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  PMID: 23351831 BACKGROUND

Related Links

• CANTAB Virtual Assessment
• WRAT-5: Wide Range Achievement Test Professional Manual

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Michael Best, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be informed that they will be randomized to one of three types of cognitive training, however, will have no idea what the conditions or the hypotheses. Outcome assessors will be blind to condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized to receive Computerized Cognitive Training only, Strategy Development only, or both (Executive Functioning Training; ET).

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: February 1, 2021
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)