Neurological Changes With a Memory Self-efficacy Training Protocol

Mild Cognitive Impairment Clinical Trial

Official title:

Neurological Changes With a Memory Self-efficacy Training Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04077320
• Other study ID #: BSCAN1920
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: December 2023
• Source: Western University, Canada
• Contact: Lindsay S Nagamatsu, PhD
• Phone: 519-661-2111
• Email: lindsay.nagamatsu[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Memory 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.
• General Education
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.

Locations

Country	Name	City	State
Canada	Community	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	Western BrainsCAN

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Memory self-efficacy: Multifactorial Memory Questionnaire (MMQ)	Multifactorial 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.	Pre and Post intervention - 6 weeks
Other	Memory self-efficacy: Memory Self-efficacy Questionnaire (MSEQ) subjective scale	Memory 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.	Pre and Post intervention - 6 weeks
Primary	Neurological bio-markers: Regional activation	Using fMRI identify changes in activation patterns or signal change when performing an associative memory task	Pre and Post intervention - 6 weeks
Primary	Neurological bio-markers: Default mode network	Using fMRI during a resting state observe changes in default mode network activation	Pre and Post intervention - 6 weeks
Secondary	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.	Pre and Post intervention - 6 weeks
Secondary	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.	Pre and Post intervention - 6 weeks
Secondary	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.	Pre and Post intervention - 6 weeks
Secondary	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	Pre and Post intervention - 6 weeks
Secondary	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	Pre and Post intervention - 6 weeks
Secondary	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	Pre and Post intervention - 6 weeks
Secondary	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.	Pre and Post intervention - 6 weeks