Clinical trial NCT04756388: Examining Strategy Monitoring and Remediation Training
Official title: E-SMART: Examining Strategy Monitoring and Remediation Training for Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Executive Dysfunction
Keywords: psychosis
schizophrenia
cognitive remediation
executive functioning
strategy monitoring
computerized practice
cognitive training
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive Computerized Cognitive Training only, Strategy Development only, or both (Executive Functioning Training; ET).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Specific Levels of Functioning Scale
timeFrame: Change from Baseline to 12-Week Follow-up
Secondary outcomes:
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: Change from Baseline to 12-Week Follow-up
measure: Wide Range Achievement Test (WRAT)
timeFrame: Change from Baseline to 12-Week Follow-up
measure: Questionnaire About the Process of Recovery (QPR)
timeFrame: Change from Baseline to 12-Week Follow-up
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: Change from Baseline to 12-Week Follow-up
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
timeFrame: Change from Baseline to 12-Week Follow-up
measure: Dysfunctional Attitudes Scale (DAS)
timeFrame: Change from Baseline to 12-Week Follow-up
measure: Brief Core Schema Scale (BCSS)
timeFrame: Change from Baseline to 12-Week Follow-up
measure: Generalized Self-Efficacy Scale (GSES)
timeFrame: Change from Baseline to 12-Week Follow-up
measure: Cognitive Failures Questionnaire (CFQ)
timeFrame: Change from Baseline to 12-Week Follow-up
measure: Need for Cognition Scale (NCS)
timeFrame: Change from Baseline to 12-Week Follow-up
measure: Davos Assessment of Cognitive Biases (DACOBS)
timeFrame: Change from Baseline to 12-Week Follow-up
measure: Motivation and Pleasure Scale - Self-Report (MAP-SR)
timeFrame: Change from Baseline to 12-Week Follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto Scarborough
state: Ontario
Study officials:
affiliation: University of Toronto
name: Michael Best, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.4088/jcp.v66n0906.
citation: Palmer BA, Pankratz VS, Bostwick JM. The lifetime risk of suicide in schizophrenia: a reexamination. Arch Gen Psychiatry. 2005 Mar;62(3):247-53. doi: 10.1001/archpsyc.62.3.247.
citation: Eack SM, Newhill CE. Psychiatric symptoms and quality of life in schizophrenia: a meta-analysis. Schizophr Bull. 2007 Sep;33(5):1225-37. doi: 10.1093/schbul/sbl071. Epub 2007 Jan 4.
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. doi: 10.1176/ajp.2007.164.3.428.
citation: 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.
citation: 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.
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.
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.
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(Suppl 2):S80-90. doi: 10.1093/schbul/sbr064.
citation: 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.
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. doi: 10.1016/j.scog.2014.01.004.
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.
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.
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.
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.
citation: 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. doi: 10.1017/S0033291706007355. Epub 2006 Mar 27.
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.
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.
citation: Cacioppo JT, Petty RE, Quintanar LR. Individual differences in relative hemispheric alpha abundance and cognitive responses to persuasive communications. J Pers Soc Psychol. 1982 Sep;43(3):623-36. doi: 10.1037//0022-3514.43.3.623.
citation: van der Gaag M, Schutz 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.
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.