Making Memory Better for Seniors With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive training
Sponsored by

About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Aging, Memory, Executive Function, Cognitive Intervention, Memory Training, Mental Health
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Mild Cognitive Impairment
Exclusion Criteria:
- Clinical diagnosis of dementia
- History of neurological conditions known to impair cognition
- History of alcohol or drug abuse
- History of chronic psychiatric illness
- Current symptoms of moderate to severe depression (Geriatric Depression Scale >19) or anxiety (Beck Anxiety Inventory >15)
Sites / Locations
- Neuropsychology Service, Nova Scotia Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cognitive training
No cognitive training
Arm Description
Outcomes
Primary Outcome Measures
Change in everyday memory functioning
Rivermead Behavioural Memory Test (3rd Edition)
Secondary Outcome Measures
Change on traditional memory testing
California Verbal Learning Test (2nd Edition)
Change in memory perception
Multifactorial Metamemory Questionnaire
Change in mood (i.e., self-report symptoms of depression)
Geriatric Depression Scale
Change in mood (i.e., self-report symptoms of anxiety)
Beck Anxiety Inventory
Change in other psychiatric symptoms (informant-report)
Neuropsychiatric Inventory
Change in quality of life
Zarit Burden Interview
Change in caregiver burden
Zarit Burden Interview
Feasibility
Recruitment, retention, and compliance rates
Full Information
NCT ID
NCT01532739
First Posted
February 10, 2012
Last Updated
August 8, 2016
Sponsor
Karen Chipman
Collaborators
Nova Scotia Health Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01532739
Brief Title
Making Memory Better for Seniors With Mild Cognitive Impairment
Official Title
Neuropsychological Intervention for a Seniors Mental Health Population With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karen Chipman
Collaborators
Nova Scotia Health Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the feasibility and effectiveness of a cognitive training group in individuals with Mild Cognitive Impairment, using a new paradigm that will optimize ecological validity by (1) focusing on everyday memory problems, (2) supplementing traditional memory training with the teaching of an empirically-supported problem-solving approach, and (3) employing a clinically representative sample of individuals with MCI (e.g., not excluding those with mild affective symptoms).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Aging, Memory, Executive Function, Cognitive Intervention, Memory Training, Mental Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive training
Arm Type
Experimental
Arm Title
No cognitive training
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Description
The cognitive training consists of 10 weekly 2-hour sessions. It is run with groups of MCI participants and their study partners (who help with reinforcing the strategies in everyday activities). The program provides information about memory and lifestyle factors in the first two weeks, followed by training and practice over the next eight weeks on empirically-supported cognitive strategies known to be effective at supporting day-to-day remembering in MCI. Participants learn to apply a core set of strategies (spaced retrieval, memory book logging) across a variety of common memory problems (e.g., remembering names, appointments, etc). To enhance the likelihood that these strategies will transfer to other settings beyond training, participants are also taught a memory problem solving approach that will cue them to recognize situations in which they need to: (1) stop and remember something, (2) select and apply an appropriate memory strategy, and (3) monitor that it is working.
Primary Outcome Measure Information:
Title
Change in everyday memory functioning
Description
Rivermead Behavioural Memory Test (3rd Edition)
Time Frame
Measured at baseline and months 3, 5, 8
Secondary Outcome Measure Information:
Title
Change on traditional memory testing
Description
California Verbal Learning Test (2nd Edition)
Time Frame
Measured at baseline and months 3, 5, 8
Title
Change in memory perception
Description
Multifactorial Metamemory Questionnaire
Time Frame
Measured at baseline and months 3, 5, 8
Title
Change in mood (i.e., self-report symptoms of depression)
Description
Geriatric Depression Scale
Time Frame
Measured at baseline and months 3, 5, 8
Title
Change in mood (i.e., self-report symptoms of anxiety)
Description
Beck Anxiety Inventory
Time Frame
Measured at baseline and months 3, 5, 8
Title
Change in other psychiatric symptoms (informant-report)
Description
Neuropsychiatric Inventory
Time Frame
Measured at baseline and months 3, 5, 8
Title
Change in quality of life
Description
Zarit Burden Interview
Time Frame
Measured at baseline and months 3, 5, 8
Title
Change in caregiver burden
Description
Zarit Burden Interview
Time Frame
Measured at baseline and months 3, 5, 8
Title
Feasibility
Description
Recruitment, retention, and compliance rates
Time Frame
Measured at end of study
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Mild Cognitive Impairment
Exclusion Criteria:
Clinical diagnosis of dementia
History of neurological conditions known to impair cognition
History of alcohol or drug abuse
History of chronic psychiatric illness
Current symptoms of moderate to severe depression (Geriatric Depression Scale >19) or anxiety (Beck Anxiety Inventory >15)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen A Chipman, PhD
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuropsychology Service, Nova Scotia Hospital
City
Dartmouth
State/Province
Nova Scotia
ZIP/Postal Code
B2Y 3Z9
Country
Canada
12. IPD Sharing Statement
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Making Memory Better for Seniors With Mild Cognitive Impairment
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