Online Cognitive Rehabilitation of Executive Dysfunction in Nonamnestic MCI

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: Online Goal Management Training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online Goal Management Training (GMT)<br>The online version of GMT with a therapist on the back-end monitoring progress and giving feedback throughout the program. Online GMT takes 5-9 weeks (self-paced) to complete 9 modules involving instructional video with interactive content, practice of cognitive strategies through games, and between-module exercises. | Behavioral: Online Goal Management Training<br>* 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.<br>* Other names: GMT;|
| No Intervention: Treatment-as-usual control group<br>Participants randomized to this arm will receive no additional information or access to the intervention program. They will continue to receive treatment-as-usual from their care providers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in associative memory | Face-name task associative memory score (Troyer et al., 2012). | Pre-intervention; Immediately post-intervention; 6 weeks post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nonamnestic MCI, executive functions, online cognitive intervention, online cognitive rehabilitation