- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532739
Making Memory Better for Seniors With Mild Cognitive Impairment
August 8, 2016 updated by: Karen Chipman
Neuropsychological Intervention for a Seniors Mental Health Population With Mild Cognitive Impairment
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- 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 Locations
-
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Nova Scotia
-
Dartmouth, Nova Scotia, Canada, B2Y 3Z9
- Neuropsychology Service, Nova Scotia Hospital
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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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
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: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive training
|
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.
|
No Intervention: No cognitive training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in everyday memory functioning
Time Frame: Measured at baseline and months 3, 5, 8
|
Rivermead Behavioural Memory Test (3rd Edition)
|
Measured at baseline and months 3, 5, 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change on traditional memory testing
Time Frame: Measured at baseline and months 3, 5, 8
|
California Verbal Learning Test (2nd Edition)
|
Measured at baseline and months 3, 5, 8
|
Change in memory perception
Time Frame: Measured at baseline and months 3, 5, 8
|
Multifactorial Metamemory Questionnaire
|
Measured at baseline and months 3, 5, 8
|
Change in mood (i.e., self-report symptoms of depression)
Time Frame: Measured at baseline and months 3, 5, 8
|
Geriatric Depression Scale
|
Measured at baseline and months 3, 5, 8
|
Change in mood (i.e., self-report symptoms of anxiety)
Time Frame: Measured at baseline and months 3, 5, 8
|
Beck Anxiety Inventory
|
Measured at baseline and months 3, 5, 8
|
Change in other psychiatric symptoms (informant-report)
Time Frame: Measured at baseline and months 3, 5, 8
|
Neuropsychiatric Inventory
|
Measured at baseline and months 3, 5, 8
|
Change in quality of life
Time Frame: Measured at baseline and months 3, 5, 8
|
Zarit Burden Interview
|
Measured at baseline and months 3, 5, 8
|
Change in caregiver burden
Time Frame: Measured at baseline and months 3, 5, 8
|
Zarit Burden Interview
|
Measured at baseline and months 3, 5, 8
|
Feasibility
Time Frame: Measured at end of study
|
Recruitment, retention, and compliance rates
|
Measured at end of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen A Chipman, PhD, Nova Scotia Health Authority
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
April 1, 2012
Primary Completion (Anticipated)
April 1, 2017
Study Completion (Anticipated)
April 1, 2017
Study Registration Dates
First Submitted
February 10, 2012
First Submitted That Met QC Criteria
February 10, 2012
First Posted (Estimate)
February 14, 2012
Study Record Updates
Last Update Posted (Estimate)
August 9, 2016
Last Update Submitted That Met QC Criteria
August 8, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDHA-RS/2012-227
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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-
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