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Neurological Changes With a Memory Self-efficacy Training Protocol

Neurological Changes With a Memory Self-efficacy Training Protocol

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04077320
Enrollment
28
Registered
2019-09-04
Start date
2023-08-01
Completion date
2024-09-23
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

memory, older adults, randomized control trial, MRI, memory education

Brief 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. 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.

Interventions

BEHAVIORALMemory Self-Efficacy Training

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.

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.

Sponsors

Western BrainsCAN
CollaboratorUNKNOWN
Western University, Canada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants will be unaware of the content of alternate groups. Both arms will be described as Learning and Aging groups to the participants

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Subjective memory complaints within past 5 years 2. Objective memory impairment below age norms on standardized cognitive testing 3. Score below 25 on Montreal Cognitive Assessment 4. Scores 1.5 standard deviations below age norms on memory testing 5. Unimpaired performance in Activities of Daily Living 6. Intact general cognition 7. Fluently read, write and speak English 8. Right handed

Exclusion criteria

1. Co-morbidity that would impact cognition (depression, anxiety, stroke) 2. Prior diagnosis of dementia of any type 3. Use of prescription or recreational drug use that would impact cognition (excluding hormone replacement therapy) 4. Uncorrected visual or auditory deficits/impairments 5. Current participation in alternate study

Design outcomes

Primary

MeasureTime frameDescription
Neurological bio-markers: Regional activationPre and Post intervention - 6 weeksUsing fMRI identify changes in activation patterns or signal change when performing an associative memory task
Neurological bio-markers: Default mode networkPre and Post intervention - 6 weeksUsing fMRI during a resting state observe changes in default mode network activation

Secondary

MeasureTime frameDescription
List Recall - Trained memory performance tasksPre and Post intervention - 6 weeksObserve 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.
Face-Name Pairs - Trained memory performance tasksPre and Post intervention - 6 weeksObserve 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.
Visual Spatial Learning Task - Untrained memory performance tasksPre and Post intervention - 6 weeksObserve 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
Digit Span Task - Untrained memory performance tasksPre and Post intervention - 6 weeksObserve 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
Face-Scene Pairs - Untrained memory performance tasksPre and Post intervention - 6 weeksObserve 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.
RAVLT - Untrained memory performance tasksPre and Post intervention - 6 weeksObserve 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
Story Recall - Trained memory performance taskPre and Post intervention - 6 weeksObserve 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.

Other

MeasureTime frameDescription
Memory self-efficacy: Multifactorial Memory Questionnaire (MMQ)Pre and Post intervention - 6 weeksMultifactorial Memory Questionnaire (MMQ), 5-point scale Likert questions (min 0, max 4) evaluating subjective memory satisfaction, ability and strategy use. Satisfaction: 18 questions. Raw scores can be converted to T Scores using the normative data presented in MMQ administration and scoring manual. Converted T-Scores can range from 15 to 85. T-scores between 40-60 are considered normal relative to the population. While those below 40 are considered low scores and those above 60 high scores. Ability: 20 questions. Raw scores can be converted to T Scores using the normative data presented in MMQ administration and scoring manual. Interpretation of T-scores same as above sub-scale. Strategy: 19 questions. Raw scores can be converted to T Scores using the normative data presented in MMQ administration and scoring manual. Interpretation of T-scores same as above sub-scale. Each of the three MMQ scales is scored and interpreted separately.
Memory self-efficacy: Memory Self-efficacy Questionnaire (MSEQ) subjective scalePre and Post intervention - 6 weeksMemory self efficacy will be evaluated and compared between groups to evaluate the efficacy of each intervention arm. As there is no one measure that is the gold standard for memory self-efficacy two validated measures will be used for comparison. Measure by 2) Memory Self-efficacy Questionnaire (MSEQ) subjective scale of participant's confidence in completing various memory related tasks. Each task is scored by percent confidence of successfully completing the task (0 - 100%) Total memory self-efficacy is calculated by summing each task and taking the average. Values closer to 0% represent a worse overall memory self-efficacy, while values closer to 100% represent better memory self-efficacy.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026