Examining Strategy Monitoring and Remediation Training

Not Applicable

Recruiting

• Conditions: Psychotic Disorders; Executive Dysfunction
• Interventions: Other: Computerized Cognitive Training; Other: Strategy Development

• Registration Number: NCT04756388
• Lead Sponsor: University of Toronto

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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-11
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computerized Cognitive Training only	Computerized Cognitive Training	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.
Executive Training	Strategy Development	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.
Executive Training	Computerized Cognitive 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.
Strategy Development only	Strategy Development	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.

Primary Outcome Measures

Name	Time	Method
Specific Levels of Functioning Scale	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Toronto Scarborough; 🇨🇦 Toronto, Ontario, Canada