Skip to content

Online Cognitive Rehabilitation of Executive Dysfunction in Nonamnestic MCI

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04503798
Enrollment
50
Registered
2020-08-07
Start date
2020-08-20
Completion date
2021-12-30
Last updated
2020-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Disorder, Cognitive Dysfunction, Cognitive Impairment, Mild, Mental Disorder, Neurocognitive Disorders, Nonamnestic Mild Cognitive Impairment

Keywords

nonamnestic MCI, executive functions, online cognitive intervention, online cognitive rehabilitation

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.

Interventions

BEHAVIORALOnline 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.

Sponsors

Centre for Aging and Brain Health Innovation
CollaboratorOTHER
Baycrest
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The study personnel who conduct screening and send pre/post-test surveys to participants are all blinded. Randomizer is blinded to all participant pre-test outcomes. Care providers know what their participants are doing, but not aware of the full study design, including details of the other conditions or outcome test characteristics.

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.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in dysexecutive functioning - participants' reportPre-intervention; Immediately post-intervention; 6 weeks post-interventionDysexecutive 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.
Change in cognitive failuresPre-intervention; Immediately post-intervention; 6 weeks post-interventionCognitive 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.
Change in dysexecutive functioning - carers' reportPre-intervention; Immediately post-intervention; 6 weeks post-interventionDysexecutive Functioning Index (DEX; Burgess et al., 1996) questionnaire completed by participants carers'.

Secondary

MeasureTime frameDescription
Change in Cambridge Brain Sciences online cognitive assessmentPre-intervention; Immediately post-intervention; 6 weeks post-interventionBattery of online tasks that assess aspects of memory and reasoning (Hampshire et al., 2012).
Change in associative memoryPre-intervention; Immediately post-intervention; 6 weeks post-interventionFace-name task associative memory score (Troyer et al., 2012).

Countries

Canada

Contacts

Primary ContactBrian Levine, PhD
blevine@research.baycrest.org416-785-2500
Backup ContactYushu Wang, MSc
ywang@research.baycrest.org416-785-2500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026