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Online Cognitive Rehabilitation of Executive Dysfunction in Nonamnestic MCI

Primary Purpose

Nonamnestic Mild Cognitive Impairment, Cognitive Dysfunction, Cognitive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Online Goal Management Training
Sponsored by
Baycrest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonamnestic Mild Cognitive Impairment focused on measuring nonamnestic MCI, executive functions, online cognitive intervention, online cognitive rehabilitation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Baycrest Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Online Goal Management Training (GMT)

Treatment-as-usual control group

Arm Description

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.

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 Outcome Measures

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.
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.
Change in dysexecutive functioning - carers' report
Dysexecutive Functioning Index (DEX; Burgess et al., 1996) questionnaire completed by participants carers'.

Secondary Outcome Measures

Change in Cambridge Brain Sciences online cognitive assessment
Battery of online tasks that assess aspects of memory and reasoning (Hampshire et al., 2012).
Change in associative memory
Face-name task associative memory score (Troyer et al., 2012).

Full Information

First Posted
August 5, 2020
Last Updated
August 5, 2020
Sponsor
Baycrest
Collaborators
Centre for Aging and Brain Health Innovation
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1. Study Identification

Unique Protocol Identification Number
NCT04503798
Brief Title
Online Cognitive Rehabilitation of Executive Dysfunction in Nonamnestic MCI
Official Title
Rehabilitation of Executive Dysfunction in Nonamnestic MCI Using Online Goal Management Training®
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2020 (Anticipated)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baycrest
Collaborators
Centre for Aging and Brain Health Innovation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonamnestic Mild Cognitive Impairment, Cognitive Dysfunction, Cognitive Disorder, Neurocognitive Disorders, Mental Disorder, Cognitive Impairment, Mild
Keywords
nonamnestic MCI, executive functions, online cognitive intervention, online cognitive rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online Goal Management Training (GMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment-as-usual control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online Goal Management Training
Other Intervention Name(s)
GMT
Intervention Description
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 Information:
Title
Change in dysexecutive functioning - participants' report
Description
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.
Time Frame
Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Title
Change in cognitive failures
Description
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.
Time Frame
Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Title
Change in dysexecutive functioning - carers' report
Description
Dysexecutive Functioning Index (DEX; Burgess et al., 1996) questionnaire completed by participants carers'.
Time Frame
Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Secondary Outcome Measure Information:
Title
Change in Cambridge Brain Sciences online cognitive assessment
Description
Battery of online tasks that assess aspects of memory and reasoning (Hampshire et al., 2012).
Time Frame
Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Title
Change in associative memory
Description
Face-name task associative memory score (Troyer et al., 2012).
Time Frame
Pre-intervention; Immediately post-intervention; 6 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Levine, PhD
Phone
416-785-2500
Ext
3593
Email
blevine@research.baycrest.org
First Name & Middle Initial & Last Name or Official Title & Degree
Yushu Wang, MSc
Phone
416-785-2500
Ext
2914
Email
ywang@research.baycrest.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Levine, PhD
Organizational Affiliation
Baycrest Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baycrest Health Sciences
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A2E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Levine, PhD
Phone
416-785-2500
Ext
3593
Email
blevine@research.baycrest.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10050359
Citation
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.
Results Reference
background
PubMed Identifier
7126941
Citation
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.
Results Reference
background
PubMed Identifier
11556941
Citation
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.
Results Reference
background
PubMed Identifier
10824502
Citation
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.
Results Reference
background
PubMed Identifier
21369362
Citation
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.
Results Reference
background
PubMed Identifier
17166313
Citation
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.
Results Reference
background
PubMed Identifier
23259956
Citation
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.
Results Reference
background
PubMed Identifier
23103838
Citation
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.
Results Reference
background
PubMed Identifier
29540124
Citation
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.
Results Reference
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Online Cognitive Rehabilitation of Executive Dysfunction in Nonamnestic MCI

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