Examining Strategy Monitoring and Remediation Training (E-SMART)

October 31, 2022 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

Recruiting

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 (Anticipated)

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 Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M1C 1A4
        • Recruiting
        • University of Toronto Scarborough
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Best, PhD

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

Genders Eligible for Study

All

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
This is a measure of community functioning rated by the research assessor based on an interview. The SLOF includes 43 items (see Appendix 1), 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
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. A higher score is indicative of higher skill level.
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 Psychiatric Rating Scale (BPRS)
Time Frame: Change from Baseline to 12-Week Follow-up
The BPRS measures psychopathology and symptom severity and is sensitive to changes in symptom levels. There are 18 items rated from 1-7. The minimum score is 18 and the maximum is 126. Higher scores are indicative of higher symptom levels.
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 sensitive measure of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. The raw total score is transformed into a percentage maximum possible. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Thus the formula for % maximum can also be written as (raw score -14)/56. Higher scores are indicative of higher quality of life.
Change from Baseline to 12-Week Follow-up
Dysfunctional Attitudes Scale (DAS)
Time Frame: Change from Baseline to 12-Week Follow-up
The DAS measures self-defeating attitudes theorized to underlie clinical depression and anxiety. There are 35 items rated -2 to +2. The minimum score is -70 and the maximum score is +70. Lower scores are indicative of stronger self-defeating attitude.
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
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. 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 was designed to measure perception, memory, and motor lapses in daily life. There are 25 items rated from 0-4. The most straightforward way to score the scale is simply to sum up the ratings of the 25 individual items, yielding a score from 0-100. Higher scores on the scale predict episodes of absent-mindedness in both the laboratory and everyday life, including slow performance on focused attention tasks, traffic and work accidents, and forgetting to save one's data on the computer
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 "the tendency for an individual to engage in and enjoy thinking." 18 items are rated from -4 to +4, and total scores range from -72 to +72. Higher scores represent a higher tendency to engage in and enjoy thinking, and are linked with higher levels of academic achievement.
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
Motivation and Pleasure Scale - Self-Report (MAP-SR)
Time Frame: Change from Baseline to 12-Week Follow-up
The MAP-SR assesses the motivation and pleasure domains of negative symptoms. All items are rated on a 5-point Likert scale; higher scores reflect greater pathology after reverse scoring for items 8, 10, and 12. Items are rated 0-4 with the minimum total score equaling 0 and the maximum possible score equaling 72.
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 (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

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)

November 3, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

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.

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