Short-term Cognitive Training in Late-life Depression
Primary Purpose
Depression
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive training
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, intervention studies
Eligibility Criteria
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
Sites / Locations
- Rotman Research Institute at Baycrest
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Alternative Uses Training
Word Association Training
Arm Description
In this task, subjects are asked to produce atypical and alternative uses for common daily objects.
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.
Outcomes
Primary Outcome Measures
Changes in cognitive functions including fluid intelligence, executive function, language, memory and motor speed
Computerized Executive Tasks:
Number-Letter Task
Letter-Memory Task
Stroop Task
Non-Computerized Measures:
Cattell Culture Fair Intelligence Test
Mattis Dementia Rating Scale-2 (DRS-2)
Secondary Outcome Measures
Changes in mood including depression, anxiety and apathy
Montgomery Asberg Depression Rating Scale (MADRS)
Apathy Evaluation Scale (AES)
Hamilton Anxiety Rating Scale (Ham-A)
Beck Depression Inventory (BDI)
Full Information
NCT ID
NCT01748032
First Posted
December 10, 2012
Last Updated
April 6, 2016
Sponsor
Rotman Research Institute at Baycrest
Collaborators
Baycrest
1. Study Identification
Unique Protocol Identification Number
NCT01748032
Brief Title
Short-term Cognitive Training in Late-life Depression
Official Title
The Effects of Short-term Cognitive Training on Cognition and Mood Symptoms in Late-life Depression: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Low Recruitment
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rotman Research Institute at Baycrest
Collaborators
Baycrest
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, intervention studies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alternative Uses Training
Arm Type
Other
Arm Description
In this task, subjects are asked to produce atypical and alternative uses for common daily objects.
Arm Title
Word Association Training
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Other Intervention Name(s)
cognitive intervention
Intervention Description
20 minutes/day for 5 sequential working days
Primary Outcome Measure Information:
Title
Changes in cognitive functions including fluid intelligence, executive function, language, memory and motor speed
Description
Computerized Executive Tasks:
Number-Letter Task
Letter-Memory Task
Stroop Task
Non-Computerized Measures:
Cattell Culture Fair Intelligence Test
Mattis Dementia Rating Scale-2 (DRS-2)
Time Frame
Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day
Secondary Outcome Measure Information:
Title
Changes in mood including depression, anxiety and apathy
Description
Montgomery Asberg Depression Rating Scale (MADRS)
Apathy Evaluation Scale (AES)
Hamilton Anxiety Rating Scale (Ham-A)
Beck Depression Inventory (BDI)
Time Frame
Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Mah, MD, M.H.Sc.
Organizational Affiliation
Rotman Research Institute at Baycrest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rotman Research Institute at Baycrest
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada
12. IPD Sharing Statement
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Short-term Cognitive Training in Late-life Depression
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