Clinical trial NCT04503798: Online Cognitive Rehabilitation of Executive Dysfunction in Nonamnestic MCI
Official title: Rehabilitation of Executive Dysfunction in Nonamnestic MCI Using Online Goal Management Training®
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nonamnestic Mild Cognitive Impairment
Cognitive Dysfunction
Cognitive Disorder
Neurocognitive Disorders
Mental Disorder
Cognitive Impairment, Mild
Keywords: nonamnestic MCI
executive functions
online cognitive intervention
online cognitive rehabilitation
Lead sponsor: Baycrest
Sponsor class: OTHER
Collaborators: name: Centre for Aging and Brain Health Innovation
First posted: 2020-08-07
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are screened, undergo a battery of tests at pre-test, and then are randomly assigned to one of two conditions: online GMT intervention or treatment-as-usual control group. After the intervention, the participants take the same test battery and complete it once more at 6 week follow-up.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in dysexecutive functioning - participants' report
timeFrame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
measure: Change in cognitive failures
timeFrame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
measure: Change in dysexecutive functioning - carers' report
timeFrame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Secondary outcomes:
measure: Change in Cambridge Brain Sciences online cognitive assessment
timeFrame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
measure: Change in associative memory
timeFrame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
Study officials:
affiliation: Baycrest Health Sciences
name: Brian Levine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1017/s1355617798466037.
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: 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. doi: 10.1046/j.1525-1497.2001.016009606.x.
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. doi: 10.1017/s1355617700633052.
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.
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. doi: 10.1017/S1355617707070178.
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.
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.
citation: Stamenova V, Levine B. Effectiveness of goal management training(R) 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.