Neurological Changes With a Memory Self-efficacy Training Protocol

Sponsor
Western University, Canada (Other)
Overall Status
Unknown status
CT.gov ID
NCT04077320
Collaborator
Western BrainsCAN (Other)
52
1
2
11
4.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Memory Self-Efficacy Training
  • Behavioral: General Education
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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
Primary Purpose:
Supportive Care
Official Title:
Neurological Changes With a Memory Self-efficacy Training Protocol
Anticipated Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Memory Self-Efficacy Training

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

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.

Outcome Measures

Primary Outcome Measures

  1. Neurological bio-markers: Regional activation [Pre and Post intervention - 6 weeks]

    Using fMRI identify changes in activation patterns or signal change when performing an associative memory task

  2. Neurological bio-markers: Default mode network [Pre and Post intervention - 6 weeks]

    Using fMRI during a resting state observe changes in default mode network activation

Secondary Outcome Measures

  1. Story Recall - Trained memory performance task [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.

  2. List Recall - Trained memory performance tasks [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.

  3. Face-Name Pairs - Trained memory performance tasks [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.

  4. RAVLT - Untrained memory performance tasks [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

  5. Visual Spatial Learning Task - Untrained memory performance tasks [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

  6. Digit Span Task - Untrained memory performance tasks [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

  7. Face-Scene Pairs - Untrained memory performance tasks [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.

Other Outcome Measures

  1. Memory self-efficacy: Multifactorial Memory Questionnaire (MMQ) [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.

  2. Memory self-efficacy: Memory Self-efficacy Questionnaire (MSEQ) subjective scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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 (Including hormone replacement therapy)

  4. Uncorrected visual or auditory deficits/impairments

  5. Current participation in alternate study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Community London Ontario Canada

Sponsors and Collaborators

  • Western University, Canada
  • Western BrainsCAN

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lindsay Nagamatsu, Assistant Professor, Western University, Canada
ClinicalTrials.gov Identifier:
NCT04077320
Other Study ID Numbers:
  • BSCAN1920
First Posted:
Sep 4, 2019
Last Update Posted:
Sep 9, 2019
Last Verified:
Sep 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lindsay Nagamatsu, Assistant Professor, Western University, Canada
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 9, 2019