E-SMART: Examining Strategy Monitoring and Remediation Training
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Specific Levels of Functioning Scale [Change from Baseline to 12-Week Follow-up]
This is a measure of community functioning rated by the research assessor based on an interview
Secondary Outcome Measures
- 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.
- 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.
- 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.
- Brief Psychiatric Rating Scale (BPRS) [Change from Baseline to 12-Week Follow-up]
The BPRS measures psychopathology and symptom severity and is sensitive to changes in symptom levels.
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [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.
- Dysfunctional Attitudes Scale (DAS) [Change from Baseline to 12-Week Follow-up]
The DAS measures self-defeating attitudes theorized to underlie clinical depression and anxiety.
- 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.
- 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.
- Cognitive Failures Questionnaire (CFQ) [Change from Baseline to 12-Week Follow-up]
The CFQ was designed to measure perception, memory, and motor lapses in daily life.
- Need for Cognition Scale (NCS) [Change from Baseline to 12-Week Follow-up]
The NCS measures "the tendency for an individual to engage in and enjoy thinking."
- 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.
- Motivation and Pleasure Scale - Self-Report (MAP-SR) [Change from Baseline to 12-Week Follow-up]
The MAP-SR assesses the motivation and pleasure domains of negative symptoms.
Eligibility Criteria
Criteria
Inclusion Criteria:
The target population for this study are those who meet the criteria for schizophrenia based on the DSM-V diagnosis. The inclusion criteria is anyone who meets the criteria of schizophrenia, schizoaffective disorder or any other psychotic disorder, are also 18-65 years of age, know how to use a computer, are not abusing drugs or alcohol and can read and speak English.
Exclusion Criteria:
Exclusion criteria include anyone enrolled in a cognitive training program in the last 6 months, anyone with a neurological disease or neurological damage, medical illnesses that can change neurocognitive function, medical history of head injury with loss of consciousness and those with physical handicaps.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Toronto Scarborough | Toronto | Ontario | Canada | M1C 1A4 |
Sponsors and Collaborators
- University of Toronto
Investigators
- Principal Investigator: Michael Best, PhD, University of Toronto
Study Documents (Full-Text)
More Information
Additional Information:
Publications
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- 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.
- 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.
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- van der Gaag M, Schütz C, Ten Napel A, Landa Y, Delespaul P, Bak M, Tschacher W, de Hert M. Development of the Davos assessment of cognitive biases scale (DACOBS). Schizophr Res. 2013 Mar;144(1-3):63-71. doi: 10.1016/j.schres.2012.12.010. Epub 2013 Jan 15.
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