Examining Strategy Monitoring and Remediation Training

Psychotic Disorders Clinical Trial

— E-SMART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04756388
• Other study ID #: 39698
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 2023

Study information

• Verified date: October 2022
• Source: University of Toronto
• Contact: Michael Best, PhD
• Phone: 416-208-4825
• Email: m.best[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Executive Dysfunction
• Mental Disorders
• Psychotic Disorders

Intervention

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.
• Computerized Cognitive Training
Participants practice computerized training exercises targeting executive functioning skills, and complete computerized exercises between sessions.

Locations

Country	Name	City	State
Canada	University of Toronto Scarborough	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (21)

Best MW, Bowie CR. A review of cognitive remediation approaches for schizophrenia: from top-down to bottom-up, brain training to psychotherapy. Expert Rev Neurother. 2017 Jul;17(7):713-723. doi: 10.1080/14737175.2017.1331128. Epub 2017 May 24. Review. — View Citation

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. — View Citation

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. — View Citation

Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x. — View Citation

Cacioppo JT, Petty RE. The need for cognition. Journal of Personality and Social Psychology. 1982; 42: 116-131.

Eack SM, Hogarty GE, Cho RY, Prasad KM, Greenwald DP, Hogarty SS, Keshavan MS. Neuroprotective effects of cognitive enhancement therapy against gray matter loss in early schizophrenia: results from a 2-year randomized controlled trial. Arch Gen Psychiatry. 2010 Jul;67(7):674-82. doi: 10.1001/archgenpsychiatry.2010.63. Epub 2010 May 3. — View Citation

Eack SM, Newhill CE. Psychiatric symptoms and quality of life in schizophrenia: a meta-analysis. Schizophr Bull. 2007 Sep;33(5):1225-37. Epub 2007 Jan 4. — View Citation

Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6. — View Citation

Faustman WO, Overall JE. (1999). Brief Psychiatric Rating Scale. In M. E. Maruish (Ed.), The use of psychological testing for treatment planning and outcomes assessment (p. 791-830). Lawrence Erlbaum Associates Publishers.

Fowler D, Freeman D, Smith B, Kuipers E, Bebbington P, Bashforth H, Coker S, Hodgekins J, Gracie A, Dunn G, Garety P. The Brief Core Schema Scales (BCSS): psychometric properties and associations with paranoia and grandiosity in non-clinical and psychosis samples. Psychol Med. 2006 Jun;36(6):749-59. Epub 2006 Mar 27. — View Citation

Llerena K, Park SG, McCarthy JM, Couture SM, Bennett ME, Blanchard JJ. The Motivation and Pleasure Scale-Self-Report (MAP-SR): reliability and validity of a self-report measure of negative symptoms. Compr Psychiatry. 2013 Jul;54(5):568-74. doi: 10.1016/j.comppsych.2012.12.001. Epub 2013 Jan 22. — View Citation

Neil ST, Kilbride M, Pitt L, Nothard S, Welford M, Sellwood W, Morrison AP. The questionnaire about the process of recovery (QPR): A measurement tool developed in collaboration with service users. Psychosis. 2009; 1(2): 145-155.

Palmer BA, Pankratz VS, Bostwick JM. The lifetime risk of suicide in schizophrenia: a reexamination. Arch Gen Psychiatry. 2005 Mar;62(3):247-53. — View Citation

Ruse SA, Harvey PD, Davis VG, Atkins AS, Fox KH, Keefe RS. Virtual Reality Functional Capacity Assessment In Schizophrenia: Preliminary Data Regarding Feasibility and Correlations with Cognitive and Functional Capacity Performance. Schizophr Res Cogn. 2014 Mar;1(1):e21-e26. — View Citation

Schwarzer R, Jerusalem M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON.

Subramaniam K, Luks TL, Fisher M, Simpson GV, Nagarajan S, Vinogradov S. Computerized cognitive training restores neural activity within the reality monitoring network in schizophrenia. Neuron. 2012 Feb 23;73(4):842-53. doi: 10.1016/j.neuron.2011.12.024. — View Citation

Swartz MS, Perkins DO, Stroup TS, Davis SM, Capuano G, Rosenheck RA, Reimherr F, McGee MF, Keefe RS, McEvoy JP, Hsiao JK, Lieberman JA; CATIE Investigators. Effects of antipsychotic medications on psychosocial functioning in patients with chronic schizophrenia: findings from the NIMH CATIE study. Am J Psychiatry. 2007 Mar;164(3):428-36. — View Citation

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. — View Citation

Weissman AN, Beck AT. Development and validation of the dysfunctional Attitude Scale: A preliminary investigation. Paper presented at the Association for the Advancement of Behavior Therapy; Chicago. 1978.

Wu EQ, Birnbaum HG, Shi L, Ball DE, Kessler RC, Moulis M, Aggarwal J. The economic burden of schizophrenia in the United States in 2002. J Clin Psychiatry. 2005 Sep;66(9):1122-9. — View Citation

Wykes T, Spaulding WD. Thinking about the future cognitive remediation therapy--what works and could we do better? Schizophr Bull. 2011 Sep;37 Suppl 2:S80-90. doi: 10.1093/schbul/sbr064. Review. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline to 12-Week Follow-up
Secondary	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.	Change from Baseline to 12-Week Follow-up
Secondary	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.	Change from Baseline to 12-Week Follow-up
Secondary	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.	Change from Baseline to 12-Week Follow-up
Secondary	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.	Change from Baseline to 12-Week Follow-up
Secondary	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.	Change from Baseline to 12-Week Follow-up
Secondary	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.	Change from Baseline to 12-Week Follow-up
Secondary	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 ?ve-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
Secondary	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.	Change from Baseline to 12-Week Follow-up
Secondary	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	Change from Baseline to 12-Week Follow-up
Secondary	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.	Change from Baseline to 12-Week Follow-up
Secondary	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.	Change from Baseline to 12-Week Follow-up
Secondary	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.	Change from Baseline to 12-Week Follow-up

External Links

•   CANTAB Virtual Assessment
•   WRAT-5: Wide Range Achievement Test Professional Manual