Recruiting

GMT

Sponsor:

Baycrest

Code:

NCT04503798

Conditions

Nonamnestic Mild Cognitive Impairment

Cognitive Dysfunction

Cognitive Disorder

Neurocognitive Disorders

Mental Disorder

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Online Goal Management Training

Study Details

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.

Conditions

Nonamnestic Mild Cognitive Impairment

Cognitive Dysfunction

Cognitive Disorder

Neurocognitive Disorders

Mental Disorder

Study ID

NCT04503798

Start date

Aug 20, 2020

Status verified date

Aug, 2020

Completion date

Dec 30, 2021

Anticipated

Primary completion date

Oct 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Change in dysexecutive functioning - participants' report [ Time Frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention ]
  • Change in cognitive failures [ Time Frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention ]
  • Change in dysexecutive functioning - carers' report [ Time Frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention ]

Central Contacts and Locations

Locations

Baycrest Health Sciences

Recruiting

Toronto, Ontario, Canada, M6A2E1

Contacts

More Information

Sponsor

Baycrest

Last update posted

Aug 7, 2020

Last verified

Aug, 2020

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baycrest on 2020-08-07.