Rehabilitation of Executive Dysfunction in Nonamnestic MCI Using Online Goal Management Training®
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in dysexecutive functioning - participants' report
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, 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.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Online Goal Management Training (GMT)
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.
Intervention: Online Goal Management Training (Behavioral)
Treatment-as-usual control group
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.
Outcomes
Primary Outcomes
Change in dysexecutive functioning - participants' report
Time Frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
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.
Change in cognitive failures
Time Frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
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.
Change in dysexecutive functioning - carers' report
Time Frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Dysexecutive Functioning Index (DEX; Burgess et al., 1996) questionnaire completed by participants carers'.
Secondary Outcomes
- Change in Cambridge Brain Sciences online cognitive assessment(Pre-intervention; Immediately post-intervention; 6 weeks post-intervention)
- Change in associative memory(Pre-intervention; Immediately post-intervention; 6 weeks post-intervention)
Investigators
Brian Levine
Senior Scientist
Baycrest