Nonamnestic Mild Cognitive ImpairmentNCT04503798
Online Cognitive Rehabilitation of Executive Dysfunction in Nonamnestic MCI
A study testing Online Goal Management Training in people with Nonamnestic Mild Cognitive Impairment and Cognitive Dysfunction, run by Baycrest at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nonamnestic Mild Cognitive Impairment, Cognitive Dysfunction, Cognitive Disorder
- What is being tested?
- Online Goal Management Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2020to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Baycrest Health Sciences
Toronto, Ontario, M6A2E1
Brian Levine, PhD, 416-785-2500 ext. 3593, blevine@research.baycrest.org
About this study
Official title: 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.
- Conditions
- Nonamnestic Mild Cognitive Impairment, Cognitive Dysfunction, Cognitive Disorder, Neurocognitive Disorders, Mental Disorder, Cognitive Impairment, Mild
- Being tested
- Online Goal Management Training
- Keywords
- nonamnestic MCI, executive functions, online cognitive intervention, online cognitive rehabilitation
- Medical subject headings
- Cognitive Dysfunction, Neurocognitive Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Goal Management TrainingBehavioural
Also called GMT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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'.
Measured: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Secondary outcomes (2)
Change in Cambridge Brain Sciences online cognitive assessment
Battery of online tasks that assess aspects of memory and reasoning (Hampshire et al., 2012).
Measured: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Change in associative memory
Face-name task associative memory score (Troyer et al., 2012).
Measured: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start20 Aug 2020 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Nonamnestic Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation
- Responsible party
- Principal investigator, Brian Levine, Baycrest
- Investigators
- Brian Levine, PhD, Principal investigator, Baycrest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503798
- Sponsor's protocol ID
- #08-53
- Status last verified
- Aug 2020
- First submitted
- 5 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10050359Broadbent 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.
PubMed 7126941Kroenke 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.
PubMed 11556941Levine 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.
PubMed 10824502Levine 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.
PubMed 21369362Levine 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.
PubMed 17166313Hampshire 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.
PubMed 23259956Troyer 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.
PubMed 23103838Stamenova 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.
PubMed 29540124
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Executive Dysfunction in Nonamnestic MCI Using Online Goal Management Training®
- ClinicalTrials.gov ID
- NCT04503798
- Acronym / sponsor ID
- #08-53
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation
- Study start
- 20 Aug 2020 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Online Goal Management Training (GMT) | Experimental | Behavioral: Online Goal Management TrainingThe 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Goal Management TrainingAlso: GMTPre-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. | Behavioural | Online Goal Management Training (GMT) |
Primary outcome
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.
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.
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'.
2 secondary outcomes
Change in Cambridge Brain Sciences online cognitive assessment
Time frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Change in associative memory
Time frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Background: PubMed 10050359Burgess 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.
- Background: PubMed 7126941Broadbent 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 10824502Levine 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.
- Background: PubMed 21369362Levine 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.
- Background: PubMed 17166313Levine 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.
- Background: PubMed 23259956Hampshire 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.
- Background: PubMed 23103838Troyer 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.
- Background: PubMed 29540124Stamenova 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Levine, PhD principal investigator
Baycrest Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Goal Management Training in people with Nonamnestic Mild Cognitive Impairment and Cognitive Dysfunction, run by Baycrest at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Levine, PhD (416-785-2500 ext. 3593, blevine@research.baycrest.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dysexecutive functioning - participants' report (time frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04503798, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.