Neurological Changes With a Memory Self-efficacy Training Protocol

October 11, 2024 updated by: Lindsay Nagamatsu, Western University, Canada
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Becky R Horst, MSc
  • Phone Number: 88284 519-661-2111
  • Email: rhorst3@uwo.ca

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • Community

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Memory Self-Efficacy Training
Memory self-efficacy group training classes.
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.
Active Comparator: General Education Group
General education group classes (e.g., exercise, diet, sustainability, tc.)
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Pre and Post intervention - 6 weeks
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
Pre and Post intervention - 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Story Recall - Trained memory performance task
Time Frame: Pre and Post intervention - 6 weeks
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
List Recall - Trained memory performance tasks
Time Frame: Pre and Post intervention - 6 weeks
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
Face-Name Pairs - Trained memory performance tasks
Time Frame: Pre and Post intervention - 6 weeks
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
RAVLT - Untrained memory performance tasks
Time Frame: Pre and Post intervention - 6 weeks

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
Visual Spatial Learning Task - Untrained memory performance tasks
Time Frame: Pre and Post intervention - 6 weeks

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
Digit Span Task - Untrained memory performance tasks
Time Frame: Pre and Post intervention - 6 weeks

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
Face-Scene Pairs - Untrained memory performance tasks
Time Frame: Pre and Post intervention - 6 weeks

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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Memory self-efficacy: Multifactorial Memory Questionnaire (MMQ)
Time Frame: Pre and Post intervention - 6 weeks

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
Memory self-efficacy: Memory Self-efficacy Questionnaire (MSEQ) subjective scale
Time Frame: Pre and Post intervention - 6 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western University, Canada

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Western BrainsCAN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BSCAN1920

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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