Online Cognitive Rehabilitation of Executive Dysfunction in Nonamnestic MCI

Sponsor

Baycrest (Other)

Overall Status

Unknown status

CT.gov ID

NCT04503798

Collaborator

Centre for Aging and Brain Health Innovation (Other)

Enrollment

Location

Arms

16.3

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nonamnestic Mild Cognitive Impairment Cognitive Dysfunction Cognitive Disorder Neurocognitive Disorders Mental Disorder Cognitive Impairment, Mild	Behavioral: Online Goal Management Training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 20, 2020

Anticipated Primary Completion Date :

Oct 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: GMT
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Other Names:

GMT

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Change in dysexecutive functioning - participants' report [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 [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 [Pre-intervention; Immediately post-intervention; 6 weeks post-intervention]
Dysexecutive Functioning Index (DEX; Burgess et al., 1996) questionnaire completed by participants carers'.

Secondary Outcome Measures

Change in Cambridge Brain Sciences online cognitive assessment [Pre-intervention; Immediately post-intervention; 6 weeks post-intervention]
Battery of online tasks that assess aspects of memory and reasoning (Hampshire et al., 2012).
Change in associative memory [Pre-intervention; Immediately post-intervention; 6 weeks post-intervention]
Face-name task associative memory score (Troyer et al., 2012).

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)