Online Cognitive Rehabilitation of Executive Dysfunction in Nonamnestic MCI

August 5, 2020 updated by: Brian Levine, Baycrest

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6A2E1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baycrest

Collaborators

Centre for Aging and Brain Health Innovation

Investigators

  • Principal Investigator: Brian Levine, PhD, Baycrest Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 20, 2020

Primary Completion (ANTICIPATED)

October 30, 2021

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (ACTUAL)

August 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #08-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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