- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01748032
Short-term Cognitive Training in Late-life Depression
April 6, 2016 updated by: Linda Mah, MD, Rotman Research Institute at Baycrest
The Effects of Short-term Cognitive Training on Cognition and Mood Symptoms in Late-life Depression: A Pilot Study
The purpose of this study is to examine the effects of the alternative uses training (AUT) and word association training (WAT) on cognitive functions and mood symptoms in late-life depression (LLD).
The hypotheses are:
- post-training cognitive performance will be superior to pre-training cognitive performance
- post-training depressive symptomatology will be less severe as compared with pre-training clinical severity and
- AUT group will show better post-training cognitive performance and improved mood symptoms when compared with the WAT group.
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
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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Ontario
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Toronto, Ontario, Canada, M6A 2E1
- Rotman Research Institute at Baycrest
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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
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female
- Age >=55
- Proficiency in English
- Current depressive episode and meet criteria for DSM-IV major depressive disorder
- Hamilton Depression Rating Scale score >=15
- Able to give informed consent
- Stable medication dosages during the training period
Exclusion Criteria:
- Other DSM-IV Axis I psychiatric disorders, except for anxiety disorders due to high comorbidity with mood disorders
- Mini-Mental State Examination score of <26
- Diagnosis of dementia
- Neurological and medical conditions known to affect cognition (e.g., stroke, head injury, previous chemotherapy for cancer)
- Unstable medical illnesses requiring active treatment
- Vision or hearing impairment affecting ability to participate in training
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: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Alternative Uses Training
In this task, subjects are asked to produce atypical and alternative uses for common daily objects.
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20 minutes/day for 5 sequential working days
Other Names:
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Other: Word Association Training
In this task, subjects are asked to generate the first word that comes to their mind, and thus, encourages more general and spontaneous divergent thinking.
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20 minutes/day for 5 sequential working days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in cognitive functions including fluid intelligence, executive function, language, memory and motor speed
Time Frame: Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day
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Computerized Executive Tasks:
Non-Computerized Measures:
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Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in mood including depression, anxiety and apathy
Time Frame: Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day
|
|
Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Linda Mah, MD, M.H.Sc., Rotman Research Institute at Baycrest
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
August 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
December 10, 2012
First Submitted That Met QC Criteria
December 10, 2012
First Posted (Estimate)
December 12, 2012
Study Record Updates
Last Update Posted (Estimate)
April 7, 2016
Last Update Submitted That Met QC Criteria
April 6, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-28
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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