NCT04503798

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

August 20, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

August 5, 2020

Last Update Submit

August 5, 2020

Conditions

Nonamnestic Mild Cognitive ImpairmentCognitive DysfunctionCognitive DisorderNeurocognitive DisordersMental DisorderCognitive Impairment, Mild

Keywords

nonamnestic MCIexecutive functionsonline cognitive interventiononline cognitive rehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Online Goal Management Training (GMT)

EXPERIMENTAL

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

Treatment-as-usual control group

NO INTERVENTION

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 TrainingBEHAVIORAL

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.

Also known as: GMT
Online Goal Management Training (GMT)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baycrest Health Sciences

Toronto, Ontario, M6A2E1, Canada

RECRUITING

Related Publications (9)

  • Burgess PW, Alderman N, Evans J, Emslie H, Wilson BA. The ecological validity of tests of executive function. J Int Neuropsychol Soc. 1998 Nov;4(6):547-58. doi: 10.1017/s1355617798466037.

    PMID: 10050359BACKGROUND

  • Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.

    PMID: 7126941BACKGROUND

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND

  • Levine B, Robertson IH, Clare L, Carter G, Hong J, Wilson BA, Duncan J, Stuss DT. Rehabilitation of executive functioning: an experimental-clinical validation of goal management training. J Int Neuropsychol Soc. 2000 Mar;6(3):299-312. doi: 10.1017/s1355617700633052.

    PMID: 10824502BACKGROUND

  • Levine B, Schweizer TA, O'Connor C, Turner G, Gillingham S, Stuss DT, Manly T, Robertson IH. Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci. 2011 Feb 17;5:9. doi: 10.3389/fnhum.2011.00009. eCollection 2011.

    PMID: 21369362BACKGROUND

  • Levine B, Stuss DT, Winocur G, Binns MA, Fahy L, Mandic M, Bridges K, Robertson IH. Cognitive rehabilitation in the elderly: effects on strategic behavior in relation to goal management. J Int Neuropsychol Soc. 2007 Jan;13(1):143-52. doi: 10.1017/S1355617707070178.

    PMID: 17166313BACKGROUND

  • Hampshire A, Highfield RR, Parkin BL, Owen AM. Fractionating human intelligence. Neuron. 2012 Dec 20;76(6):1225-37. doi: 10.1016/j.neuron.2012.06.022.

    PMID: 23259956BACKGROUND

  • Troyer AK, Murphy KJ, Anderson ND, Craik FI, Moscovitch M, Maione A, Gao F. Associative recognition in mild cognitive impairment: relationship to hippocampal volume and apolipoprotein E. Neuropsychologia. 2012 Dec;50(14):3721-8. doi: 10.1016/j.neuropsychologia.2012.10.018. Epub 2012 Oct 24.

    PMID: 23103838BACKGROUND

  • Stamenova V, Levine B. Effectiveness of goal management training(R) in improving executive functions: A meta-analysis. Neuropsychol Rehabil. 2019 Dec;29(10):1569-1599. doi: 10.1080/09602011.2018.1438294. Epub 2018 Mar 14.

    PMID: 29540124BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionNeurocognitive DisordersMental Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders

Study Officials

  • Brian Levine, PhD

    Baycrest Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Levine, PhD

CONTACT

416-785-2500blevine@research.baycrest.org

Yushu Wang, MSc

CONTACT

416-785-2500ywang@research.baycrest.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 7, 2020

Study Start

August 20, 2020

Primary Completion

October 30, 2021

Study Completion

December 30, 2021

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)