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Examining Strategy Monitoring and Remediation Training (E-SMART)

Primary Purpose

Psychotic Disorders, Executive Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Strategy Development
Computerized Cognitive Training
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring psychosis, schizophrenia, cognitive remediation, executive functioning, strategy monitoring, computerized practice, cognitive training

Eligibility Criteria

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

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

Sites / Locations

  • University of Toronto ScarboroughRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Executive Training

Strategy Development only

Computerized Cognitive Training only

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Specific Levels of Functioning Scale
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.

Secondary Outcome Measures

Cambridge Neuropsychological Test Automated Battery (CANTAB)
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.
Wide Range Achievement Test (WRAT)
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.
Questionnaire About the Process of Recovery (QPR)
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.
Brief Psychiatric Rating Scale (BPRS)
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.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
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.
Dysfunctional Attitudes Scale (DAS)
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.
Brief Core Schema Scale (BCSS)
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.
Generalized Self-Efficacy Scale (GSES)
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.
Cognitive Failures Questionnaire (CFQ)
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
Need for Cognition Scale (NCS)
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.
Davos Assessment of Cognitive Biases (DACOBS)
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.
Motivation and Pleasure Scale - Self-Report (MAP-SR)
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.

Full Information

First Posted
February 11, 2021
Last Updated
October 31, 2022
Sponsor
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04756388
Brief Title
Examining Strategy Monitoring and Remediation Training
Acronym
E-SMART
Official Title
E-SMART: Examining Strategy Monitoring and Remediation Training for Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Executive Dysfunction
Keywords
psychosis, schizophrenia, cognitive remediation, executive functioning, strategy monitoring, computerized practice, cognitive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to receive Computerized Cognitive Training only, Strategy Development only, or both (Executive Functioning Training; ET).
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Executive Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Strategy Development only
Arm Type
Experimental
Arm Description
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.
Arm Title
Computerized Cognitive Training only
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Strategy Development
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Computerized Cognitive Training
Intervention Description
Participants practice computerized training exercises targeting executive functioning skills, and complete computerized exercises between sessions.
Primary Outcome Measure Information:
Title
Specific Levels of Functioning Scale
Description
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.
Time Frame
Change from Baseline to 12-Week Follow-up
Secondary Outcome Measure Information:
Title
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Description
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.
Time Frame
Change from Baseline to 12-Week Follow-up
Title
Wide Range Achievement Test (WRAT)
Description
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.
Time Frame
Change from Baseline to 12-Week Follow-up
Title
Questionnaire About the Process of Recovery (QPR)
Description
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.
Time Frame
Change from Baseline to 12-Week Follow-up
Title
Brief Psychiatric Rating Scale (BPRS)
Description
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.
Time Frame
Change from Baseline to 12-Week Follow-up
Title
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Description
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.
Time Frame
Change from Baseline to 12-Week Follow-up
Title
Dysfunctional Attitudes Scale (DAS)
Description
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.
Time Frame
Change from Baseline to 12-Week Follow-up
Title
Brief Core Schema Scale (BCSS)
Description
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.
Time Frame
Change from Baseline to 12-Week Follow-up
Title
Generalized Self-Efficacy Scale (GSES)
Description
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.
Time Frame
Change from Baseline to 12-Week Follow-up
Title
Cognitive Failures Questionnaire (CFQ)
Description
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
Time Frame
Change from Baseline to 12-Week Follow-up
Title
Need for Cognition Scale (NCS)
Description
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.
Time Frame
Change from Baseline to 12-Week Follow-up
Title
Davos Assessment of Cognitive Biases (DACOBS)
Description
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.
Time Frame
Change from Baseline to 12-Week Follow-up
Title
Motivation and Pleasure Scale - Self-Report (MAP-SR)
Description
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.
Time Frame
Change from Baseline to 12-Week Follow-up

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Best, PhD
Phone
416-208-4825
Email
m.best@utoronto.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Felicia Martins, HBSc
Email
bestlabadmin.utsc@utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Best, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toronto Scarborough
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1C 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Best, PhD
Phone
416-208-4825
Email
m.best@utoronto.ca
First Name & Middle Initial & Last Name & Degree
Felicia Martins, HBSc (IPR)
Email
bestlabadmin.utsc@utoronto.ca
First Name & Middle Initial & Last Name & Degree
Michael Best, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
http://www.cantab.com
Description
CANTAB Virtual Assessment
URL
https://books.google.ca/books?id=amQXtAEACAAJ
Description
WRAT-5: Wide Range Achievement Test Professional Manual

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