Examining Strategy Monitoring and Remediation Training (E-SMART)

July 24, 2025 updated by: Michael Best, University of Toronto

E-SMART: Examining Strategy Monitoring and Remediation Training for Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All interventions will involve 4 weeks of group treatment consisting of two 1-hour group sessions per week and additional practice at home between sessions. The Executive Training condition will 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. 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. 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.

90 participants with schizophrenia-spectrum disorders will be recruited. Power analyses, conducted with GPower, indicate that 90 participants (30 per treatment condition), accounting for an upper limit of 25% attrition observed in my previous trials of ET, provides 80% power to detect a medium effect size (cohen's f = 0.2) difference between conditions.

Primary and secondary outcomes will be examined using Linear Mixed Models on the Intent-to-Treat sample with missing data interpolated using maximum likelihood estimation. The primary endpoint is the 3-month follow-up assessment, and secondary endpoint of post-treatment will also be examined.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M1C 1A4
        • University of Toronto Scarborough

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • clinical diagnosis of schizophrenia, schizoaffective disorder or any other psychotic disorder (based on DSM-V)
  • 18-65 years of age
  • know how to use a computer
  • not abusing drugs or alcohol
  • can read and speak English.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Executive Training
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
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.
Other: Computerized Cognitive Training
Participants practice computerized training exercises targeting executive functioning skills, and complete computerized exercises between sessions.
Experimental: Strategy Development only
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
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.
Experimental: Computerized Cognitive Training only
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
Participants practice computerized training exercises targeting executive functioning skills, and complete computerized exercises between sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specific Levels of Functioning Scale
Time Frame: Change from Baseline to 12-Week Follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time Frame: Change from Baseline to 12-Week Follow-up
The CANTAB is a battery consisting of highly sensitive, precise and objective measures of cognitive function. It includes tests of working memory, learning and executive function; visual, verbal and episodic memory; attention, information processing and reaction time; social and emotion recognition, decision making and response control. A higher total score is indicative of better cognitive performance.
Change from Baseline to 12-Week Follow-up
Questionnaire About the Process of Recovery (QPR)
Time Frame: Change from Baseline to 12-Week Follow-up
The QPR was developed from service users' accounts of recovery from psychosis in collaboration with local service users. It asks people living with psychosis about aspects of recovery that are meaningful to them, and is strongly associated with general psychological wellbeing, quality of life and empowerment. There are 15 items rated from 0-4, so the minimum score is 0 and the maximum is 60. A higher score is indicative of greater personal recovery.
Change from Baseline to 12-Week Follow-up
Brief Core Schema Scale (BCSS)
Time Frame: Change from Baseline to 12-Week Follow-up
The BCSS assesses four dimensions of self and other evaluation: negative-self, positive-self, negative-other, and positive-other. The BCSS have 24 items concerning beliefs about the self and others that are assessed on a five-point rating scale (0-4). Four scores are obtained: negative-self (six items), positive-self (six items), negative-others (six items) and positive-others (six items). Higher scores are indicative of stronger belief. Scores range from 0 - 96.
Change from Baseline to 12-Week Follow-up
Davos Assessment of Cognitive Biases (DACOBS)
Time Frame: Change from Baseline to 12-Week Follow-up
The DAVOS measures cognitive biases and discriminates between schizophrenia spectrum patients and normal control subjects. 42 items are scored from 1-7, with total scores ranging from 42-294. Higher scores indicate stronger beliefs/attitudes.
Change from Baseline to 12-Week Follow-up
Wide Range Achievement Test (WRAT)
Time Frame: Change from Baseline to 12-Week Follow-up
The WRAT is an academic skills assessment which measures reading skills, math skills, spelling, and comprehension. The WRAT-3 Reading is a letter and word recognition subtest assessing reading ability. It contains 15 letters and 42 words. The lowest possible score would be a 0 and the highest score would be a 57. Higher scores are indicative of better reading ability.
Change from Baseline to 12-Week Follow-up
Brief Psychiatric Rating Scale (BPRS)
Time Frame: Change from Baseline to 12-Week Follow-up
The BPRS is an assessor-rated and interview-based measure assessing psychopathology and symptom severity. There are 24 items rated from 1-7, with 1 representing "absent" and 7 representing "extremely severe". The minimum score is 24 and the maximum is 168. Higher scores are indicative of increased symptomology.
Change from Baseline to 12-Week Follow-up
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time Frame: Change from Baseline to 12-Week Follow-up
The Q-LES-Q is a 93-item self-report measure assessing the degree of enjoyment and satisfaction experienced in areas of daily functioning, including physical health/activities (13 items), feelings (14 items), work (13 items), household duties (10 items), school/course work (10 items), leisure time activities (6 items), social relations (11 items), and general activities (16 items). Responses are rated on a 5-point scale, with 1 being "not at all or never" or "very poor" and 5 being "frequently or all of the time" or "very good". The raw total score ranges from 93 to 465, with higher scores indicative of more enjoyment and satisfaction.
Change from Baseline to 12-Week Follow-up
Dysfunctional Attitudes Scale (DAS)
Time Frame: Change from Baseline to 12-Week Follow-up
DAS is a 40-item self-report measure assessing dysfunctional beliefs. The degree of agreement to each statement is scored on a 7-point Likert scale (1 = agree totally, 2 = agree very much, 3 = agree slightly, 4 = neutral, 5 = disagree slightly, 6 = disagree very much, 7 = disagree totally). The lowest possible scale is 40 while the highest possible scale is 280. Higher scores would indicate more negative beliefs.
Change from Baseline to 12-Week Follow-up
Generalized Self-Efficacy Scale (GSES)
Time Frame: Change from Baseline to 12-Week Follow-up
The GSES assesses optimistic self-beliefs to cope with a variety of difficult demands in life. There are 10 items rated from 1-4, with 1 being "not at all true" and 4 being "exactly true". The lowest score possible is 10 and the highest is 40, with higher scores representing higher levels of optimistic self-beliefs.
Change from Baseline to 12-Week Follow-up
Cognitive Failures Questionnaire (CFQ)
Time Frame: Change from Baseline to 12-Week Follow-up
The CFQ is a 25-item self-report measure designed to assess perception, memory, and motor lapses in daily life. Frequency of experiencing each item is assessed on a 5-point scale, ranging from "0 = Never" to "4 = Very Often". The lowest score would be a 0 and the highest score would be a 100. Higher scores indicate more cognitive failures.
Change from Baseline to 12-Week Follow-up
Need for Cognition Scale (NCS)
Time Frame: Change from Baseline to 12-Week Follow-up
The NCS measures individual's tendency to engage in and enjoy thinking. Responses are rated on a 5-point scale, ranging from "1 = Extremely Unlike Me" to "5 = Extremely Like Me". The lowest score would be an 18 and the highest score would be a 90, with reverse scoring counted. Higher scores indicate increased tendency to engage in and enjoy thinking.
Change from Baseline to 12-Week Follow-up
Motivation and Pleasure Scale - Self-Report (MAP-SR)
Time Frame: Change from Baseline to 12-Week Follow-up
The MAP-SR is a 15-item self-report measure assessing the motivation and pleasure a person has experienced. (1) Social pleasure, (2) recreational or work pleasure, (3) feelings and motivations about close, caring relationships and (4) motivation and effort to engage in activities are evaluated. Responses are rated on a 5-point scale, where 0 represents "no pleasure", "not at all important to me", "not at all motivated", or "no effort", and 4 represents "extreme pleasure", "extremely important to me", "very motivated" or "very much effort". The highest score would be a 60 while the lowest score would be a 0. Higher scores indicate more pleasure and motivations.
Change from Baseline to 12-Week Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Investigators

  • Principal Investigator: Michael Best, PhD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

March 19, 2025

Study Completion (Actual)

March 19, 2025

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39698

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychotic Disorders

Clinical Trials on Strategy Development

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe