NCT04077320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
3.9 years until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

August 28, 2019

Last Update Submit

October 11, 2024

Conditions

Keywords

memoryolder adultsrandomized control trialMRImemory education

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (7)

  • Story Recall - Trained memory performance task

    Pre and Post intervention - 6 weeks

  • List Recall - Trained memory performance tasks

    Pre and Post intervention - 6 weeks

  • Face-Name Pairs - Trained memory performance tasks

    Pre and Post intervention - 6 weeks

  • RAVLT - Untrained memory performance tasks

    Pre and Post intervention - 6 weeks

  • Visual Spatial Learning Task - Untrained memory performance tasks

    Pre and Post intervention - 6 weeks

  • +2 more secondary outcomes

Other Outcomes (2)

  • Memory self-efficacy: Multifactorial Memory Questionnaire (MMQ)

    Pre and Post intervention - 6 weeks

  • Memory self-efficacy: Memory Self-efficacy Questionnaire (MSEQ) subjective scale

    Pre and Post intervention - 6 weeks

Study Arms (2)

Memory Self-Efficacy Training

EXPERIMENTAL

Memory self-efficacy group training classes.

Behavioral: Memory Self-Efficacy Training

General Education Group

ACTIVE COMPARATOR

General education group classes (e.g., exercise, diet, sustainability, tc.)

Behavioral: General Education

Interventions

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.

Memory Self-Efficacy Training

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.

General Education Group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 (excluding hormone replacement therapy)
  • Uncorrected visual or auditory deficits/impairments
  • Current participation in alternate study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community

London, Ontario, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be unaware of the content of alternate groups. Both arms will be described as "Learning and Aging" groups to the participants
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 28, 2019

First Posted

September 4, 2019

Study Start

August 1, 2023

Primary Completion

September 23, 2024

Study Completion

September 23, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations