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Neurological Changes With a Memory Self-efficacy Training Protocol

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Memory Self-Efficacy Training
General Education
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring memory, older adults, randomized control trial, MRI, memory education

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (Including hormone replacement therapy)
  4. Uncorrected visual or auditory deficits/impairments
  5. Current participation in alternate study

Sites / Locations

  • Community

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Memory Self-Efficacy Training

General Education Group

Arm Description

Outcomes

Primary Outcome Measures

Neurological bio-markers: Regional activation
Using fMRI identify changes in activation patterns or signal change when performing an associative memory task
Neurological bio-markers: Default mode network
Using fMRI during a resting state observe changes in default mode network activation

Secondary Outcome Measures

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.
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.
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.
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
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
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
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.

Full Information

First Posted
August 28, 2019
Last Updated
September 5, 2019
Sponsor
Western University, Canada
Collaborators
Western BrainsCAN
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1. Study Identification

Unique Protocol Identification Number
NCT04077320
Brief Title
Neurological Changes With a Memory Self-efficacy Training Protocol
Official Title
Neurological Changes With a Memory Self-efficacy Training Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
Collaborators
Western BrainsCAN

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
memory, older adults, randomized control trial, MRI, memory education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
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
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Memory Self-Efficacy Training
Arm Type
Experimental
Arm Title
General Education Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Memory Self-Efficacy Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
General Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neurological bio-markers: Regional activation
Description
Using fMRI identify changes in activation patterns or signal change when performing an associative memory task
Time Frame
Pre and Post intervention - 6 weeks
Title
Neurological bio-markers: Default mode network
Description
Using fMRI during a resting state observe changes in default mode network activation
Time Frame
Pre and Post intervention - 6 weeks
Secondary Outcome Measure Information:
Title
Story Recall - Trained memory performance task
Description
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.
Time Frame
Pre and Post intervention - 6 weeks
Title
List Recall - Trained memory performance tasks
Description
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.
Time Frame
Pre and Post intervention - 6 weeks
Title
Face-Name Pairs - Trained memory performance tasks
Description
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.
Time Frame
Pre and Post intervention - 6 weeks
Title
RAVLT - Untrained memory performance tasks
Description
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
Time Frame
Pre and Post intervention - 6 weeks
Title
Visual Spatial Learning Task - Untrained memory performance tasks
Description
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
Time Frame
Pre and Post intervention - 6 weeks
Title
Digit Span Task - Untrained memory performance tasks
Description
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
Time Frame
Pre and Post intervention - 6 weeks
Title
Face-Scene Pairs - Untrained memory performance tasks
Description
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.
Time Frame
Pre and Post intervention - 6 weeks
Other Pre-specified Outcome Measures:
Title
Memory self-efficacy: Multifactorial Memory Questionnaire (MMQ)
Description
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.
Time Frame
Pre and Post intervention - 6 weeks
Title
Memory self-efficacy: Memory Self-efficacy Questionnaire (MSEQ) subjective scale
Description
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.
Time Frame
Pre and Post intervention - 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 (Including hormone replacement therapy) Uncorrected visual or auditory deficits/impairments Current participation in alternate study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay S Nagamatsu, PhD
Phone
519-661-2111
Ext
82659
Email
lindsay.nagamatsu@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Becky R Horst, MSc
Phone
519-661-2111
Ext
88284
Email
rhorst3@uwo.ca
Facility Information:
Facility Name
Community
City
London
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Neurological Changes With a Memory Self-efficacy Training Protocol

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