Online Cognitive Rehabilitation of Executive Dysfunction in Nonamnestic MCI

Cognitive Dysfunction Clinical Trial

Official title:

Rehabilitation of Executive Dysfunction in Nonamnestic MCI Using Online Goal Management Training®

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04503798
• Other study ID #: #08-53
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2020
• Source: Baycrest
• Contact: Brian Levine, PhD
• Phone: 416-785-2500
• Email: blevine[@]research.baycrest.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nonamnestic mild cognitive impairment (naMCI) is a prodromal state characterized by deficits in executive functioning, a collection of higher-order abilities involved in organization, planning, inhibition, and complex reasoning. Research shows that individuals with naMCI have an increased risk of developing non-Alzheimer's dementia such as frontotemporal dementia and dementia with Lewy bodies, which pose substantial personal and societal costs. Accordingly, interventions that can successfully slow down or reverse the course of naMCI are needed.

Goal Management Training (GMT) is a cognitive rehabilitation platform that has been studied extensively, applied clinically, and manualized into kits for clinicians (Levine et al., 2000; Levine et al., 2007; Levine et al., 2011; Stamenova & Levine, 2019). The purpose of GMT is to train individuals to periodically "STOP" what they are doing, attend to task goals, evaluate their performance, and monitor or check outcomes as they proceed. Recently, an online version of GMT has been developed and validated in order to circumvent barriers to attending in-person sessions.

The purpose of the current study is to determine if the online version of GMT is effective at improving self-reported executive dysfunction in individuals diagnosed with naMCI against a control group that is receiving treatment-as-usual from their care provider. It is hypothesized that, compared to the control group, individuals receiving GMT will report a decrease in executive function deficits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of nonamnestic mild cognitive impairment

• Available to participate in all testing and intervention sessions

• Access to a computer

• Computer familiarity

• Normal or corrected-to-normal vision and hearing

Exclusion Criteria:

• Diagnosis of amnestic mild cognitive impairment or dementia

• Moderate to severe affective impairment defined by score above cut-off for depression on the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001)

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorder
• Cognitive Dysfunction
• Cognitive Impairment, Mild
• Disease
• Mental Disorder
• Mental Disorders
• Neurocognitive Disorders
• Nonamnestic Mild Cognitive Impairment

Intervention

Behavioral:
• Online Goal Management Training
Pre-recorded videos and games combine psycho-education, targeted skills training, and mindfulness practice to teach a system where participants can take control of their attention and cognitive faculties.

Locations

Country	Name	City	State
Canada	Baycrest Health Sciences	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Baycrest	Centre for Aging and Brain Health Innovation

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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. — View Citation

Burgess PW, Alderman N, Evans J, Emslie H, Wilson BA. The ecological validity of tests of executive function. J Int Neuropsychol Soc. 1998 Nov;4(6):547-58. — View Citation

Hampshire A, Highfield RR, Parkin BL, Owen AM. Fractionating human intelligence. Neuron. 2012 Dec 20;76(6):1225-37. doi: 10.1016/j.neuron.2012.06.022. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation

Levine B, Robertson IH, Clare L, Carter G, Hong J, Wilson BA, Duncan J, Stuss DT. Rehabilitation of executive functioning: an experimental-clinical validation of goal management training. J Int Neuropsychol Soc. 2000 Mar;6(3):299-312. — View Citation

Levine B, Schweizer TA, O'Connor C, Turner G, Gillingham S, Stuss DT, Manly T, Robertson IH. Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci. 2011 Feb 17;5:9. doi: 10.3389/fnhum.2011.00009. eCollection 2011. — View Citation

Levine B, Stuss DT, Winocur G, Binns MA, Fahy L, Mandic M, Bridges K, Robertson IH. Cognitive rehabilitation in the elderly: effects on strategic behavior in relation to goal management. J Int Neuropsychol Soc. 2007 Jan;13(1):143-52. — View Citation

Stamenova V, Levine B. Effectiveness of goal management training® in improving executive functions: A meta-analysis. Neuropsychol Rehabil. 2019 Dec;29(10):1569-1599. doi: 10.1080/09602011.2018.1438294. Epub 2018 Mar 14. Review. — View Citation

Troyer AK, Murphy KJ, Anderson ND, Craik FI, Moscovitch M, Maione A, Gao F. Associative recognition in mild cognitive impairment: relationship to hippocampal volume and apolipoprotein E. Neuropsychologia. 2012 Dec;50(14):3721-8. doi: 10.1016/j.neuropsychologia.2012.10.018. Epub 2012 Oct 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dysexecutive functioning - participants' report	Dysexecutive Functioning Index (DEX; Burgess et al., 1996) questionnaire measures self-reported deficits in executive functions, and is composed of one scale with scores ranging from 0-80, where higher scores indicate greater executive deficit.	Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Primary	Change in cognitive failures	Cognitive Failures Questionnaire (CFQ; Broadbent et al., 1992) measures self-reported failures in perception, memory, and motor function. It contains a single scale with scores ranging from 0-100, where higher scores indicate greater degree of impairment.	Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Primary	Change in dysexecutive functioning - carers' report	Dysexecutive Functioning Index (DEX; Burgess et al., 1996) questionnaire completed by participants carers'.	Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Secondary	Change in Cambridge Brain Sciences online cognitive assessment	Battery of online tasks that assess aspects of memory and reasoning (Hampshire et al., 2012).	Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Secondary	Change in associative memory	Face-name task associative memory score (Troyer et al., 2012).	Pre-intervention; Immediately post-intervention; 6 weeks post-intervention

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