Mild Cognitive ImpairmentNCT04077320
Neurological Changes With a Memory Self-efficacy Training Protocol
A study testing Memory Self-Efficacy Training and General Education in people with Mild Cognitive Impairment, run by Western University, Canada at 1 site in Canada.
Trial summary
Confidence in one's ability to accomplish a task, more formally known as self-efficacy, is an important psychological variable that can influence how the investigators perform on various tasks. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Memory Self-Efficacy Training and General Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2023to 23 Sep 2024
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjective memory complaints within past 5 years
- Objective memory impairment below age norms on standardized cognitive testing
- Score below 25 on Montreal Cognitive Assessment
- Scores 1.5 standard deviations below age norms on memory testing
- Unimpaired performance in Activities of Daily Living
- Intact general cognition
- Fluently read, write and speak English
- Right handed
Who cannot join
- Co-morbidity that would impact cognition (depression, anxiety, stroke)
- Prior diagnosis of dementia of any type
- Use of prescription or recreational drug use that would impact cognition (excluding hormone replacement therapy)
- Uncorrected visual or auditory deficits/impairments
- Current participation in alternate study
Trial locations and contacts
1 site in 1 country.
About this study
Confidence in one's ability to accomplish a task, more formally known as self-efficacy, is an important psychological variable that can influence how the investigators perform on various tasks. Previous studies have shown that self-efficacy is a modifiable trait that can be improved and bolstered with training and practice. More importantly for this study, memory self-efficacy has been shown to be modifiable for older adults, consequently improving their performance on memory tasks. While there is evidence to support the importance of memory self-efficacy for successful memory performance in older adults, the underlying neurological changes that accompany these performance changes have not been explored. The goal of this study is to examine the changes in brain activity before and after a memory self-efficacy training program to better understand the mechanisms of both memory and self-efficacy.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Memory Self-Efficacy Training, General Education
- Keywords
- memory, older adults, randomized control trial, MRI, memory education
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory Self-Efficacy TrainingBehavioural
The intervention will consist of a six-week cognitive behavioral intervention integrating the four pillars of self-efficacy, Mastery, Social Modeling, Coaching, and Physiological Responses (West et al. 2008). Each week will comprise of a 1.5 hour session which focuses on an educational component, discussions and active learning practice activities to apply lesson material. Additionally, participants will be given take home exercises to practice outside a classroom setting. The sessions will be conducted in small groups of 4-6 people.
General EducationBehavioural
The active control intervention will be a general education class consisting of real world knowledge and factual information on various topics unrelated to memory. This intervention will follow the same format as the memory self-efficacy training arm. One 1.5 hours session every week for 6 weeks, in small groups.
| Study group | Role | What they receive |
|---|---|---|
| Memory Self-Efficacy Training | Experimental | Memory self-efficacy group training classes. Receives: Behavioral: Memory Self-Efficacy Training |
| General Education Group | Active comparator | General education group classes (e.g., exercise, diet, sustainability, tc.) Receives: Behavioral: General Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological bio-markers: Regional activation
Using fMRI identify changes in activation patterns or signal change when performing an associative memory task
Measured: Pre and Post intervention - 6 weeks
Neurological bio-markers: Default mode network
Using fMRI during a resting state observe changes in default mode network activation
Measured: Pre and Post intervention - 6 weeks
Secondary outcomes (7)
Story Recall - Trained memory performance task
Observe the changes in memory performance using measures that were specifically practiced in the training intervention. Recall of a short story to estimate episodic memory capacity.
Measured: Pre and Post intervention - 6 weeks
List Recall - Trained memory performance tasks
Observe the changes in memory performance using measures that were specifically practiced in the training intervention. Recall of a visually presented list of unrelated words to estimate episodic memory capacity and working memory.
Measured: Pre and Post intervention - 6 weeks
Face-Name Pairs - Trained memory performance tasks
Observe the changes in memory performance using measures that were specifically practiced in the training intervention. Recall of a face-name pairs to evaluate associative memory.
Measured: Pre and Post intervention - 6 weeks
RAVLT - Untrained memory performance tasks
Observe the changes in memory performance using measures that were not specifically practiced in the training intervention.
Participants are asked to recall a list of verbally presented words immediately after presentation and after a delay. Used to evaluate sort term verbal memory and long term memory
Measured: Pre and Post intervention - 6 weeks
Visual Spatial Learning Task - Untrained memory performance tasks
Observe the changes in memory performance using measures that were not specifically practiced in the training intervention.
Subjects are given time to learn the location and design of shapes on a 6 x 4 matrix. Subjects are required to correctly select the 7 correct shapes from a selection of 15 and place them on the grid. Used to measure visual spatial memory
Measured: Pre and Post intervention - 6 weeks
Digit Span Task - Untrained memory performance tasks
Observe the changes in memory performance using measures that were not specifically practiced in the training intervention.
A series of numbers are verbally presented, increasing in length for the participant to repeat back. Measures working memory
Measured: Pre and Post intervention - 6 weeks
Face-Scene Pairs - Untrained memory performance tasks
Observe the changes in memory performance using measures that were not specifically practiced in the training intervention.
An alternative form of evaluating associative memory ability. Participants will be given face and scene pairs to remember.
Measured: Pre and Post intervention - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Aug 2023
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Western BrainsCAN
- Responsible party
- Principal investigator, Lindsay Nagamatsu, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077320
- Sponsor's protocol ID
- BSCAN1920
- Status last verified
- Oct 2024
- First submitted
- 28 Aug 2019
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Changes With a Memory Self-efficacy Training Protocol
- ClinicalTrials.gov ID
- NCT04077320
- Acronym / sponsor ID
- BSCAN1920
- Conditions
- Mild Cognitive Impairment
- Keywords
- memory, older adults, randomized control trial, MRI, memory education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Western BrainsCAN
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 4 Sep 2019 (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.
Confidence in one's ability to accomplish a task, more formally known as self-efficacy, is an important psychological variable that can influence how the investigators perform on various tasks. Previous studies have shown that self-efficacy is a modifiable trait that can be improved and bolstered with training and practice. More importantly for this study, memory self-efficacy has been shown to be modifiable for older adults, consequently improving their performance on memory tasks. While there is evidence to support the importance of memory self-efficacy for successful memory performance in older adults, the underlying neurological changes that accompany these performance changes have not been explored. The goal of this study is to examine the changes in brain activity before and after a memory self-efficacy training program to better understand the mechanisms of both memory and self-efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memory Self-Efficacy Training | Experimental | Behavioral: Memory Self-Efficacy TrainingMemory self-efficacy group training classes. |
| General Education Group | Active comparator | Behavioral: General EducationGeneral education group classes (e.g., exercise, diet, sustainability, tc.) |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjective memory complaints within past 5 years
- Objective memory impairment below age norms on standardized cognitive testing
- Score below 25 on Montreal Cognitive Assessment
- Scores 1.5 standard deviations below age norms on memory testing
- Unimpaired performance in Activities of Daily Living
Key exclusion criteria (5 listed)
- Co-morbidity that would impact cognition (depression, anxiety, stroke)
- Prior diagnosis of dementia of any type
- Use of prescription or recreational drug use that would impact cognition (excluding hormone replacement therapy)
- Uncorrected visual or auditory deficits/impairments
- Current participation in alternate study
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 |
|---|---|---|
| Memory Self-Efficacy TrainingThe intervention will consist of a six-week cognitive behavioral intervention integrating the four pillars of self-efficacy, Mastery, Social Modeling, Coaching, and Physiological Responses (West et al. 2008). Each week will comprise of a 1.5 hour session which focuses on an educational component, discussions and active learning practice activities to apply lesson material. Additionally, participants will be given take home exercises to practice outside a classroom setting. The sessions will be conducted in small groups of 4-6 people. | Behavioural | Memory Self-Efficacy Training |
| General EducationThe active control intervention will be a general education class consisting of real world knowledge and factual information on various topics unrelated to memory. This intervention will follow the same format as the memory self-efficacy training arm. One 1.5 hours session every week for 6 weeks, in small groups. | Behavioural | General Education Group |
Primary outcome
Neurological bio-markers: Regional activation
Time frame: Pre and Post intervention - 6 weeks
Using fMRI identify changes in activation patterns or signal change when performing an associative memory task
Neurological bio-markers: Default mode network
Time frame: Pre and Post intervention - 6 weeks
Using fMRI during a resting state observe changes in default mode network activation
7 secondary outcomes
Story Recall - Trained memory performance task
Time frame: Pre and Post intervention - 6 weeks
List Recall - Trained memory performance tasks
Time frame: Pre and Post intervention - 6 weeks
Face-Name Pairs - Trained memory performance tasks
Time frame: Pre and Post intervention - 6 weeks
RAVLT - Untrained memory performance tasks
Time frame: Pre and Post intervention - 6 weeks
Visual Spatial Learning Task - Untrained memory performance tasks
Time frame: Pre and Post intervention - 6 weeks
Digit Span Task - Untrained memory performance tasks
Time frame: Pre and Post intervention - 6 weeks
Face-Scene Pairs - Untrained memory performance tasks
Time frame: Pre and Post intervention - 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory Self-Efficacy Training and General Education in people with Mild Cognitive Impairment, run by Western University, Canada 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 15 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological bio-markers: Regional activation (time frame: Pre and Post intervention - 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.