Cognitive Activation Therapy for MCI: A Randomized Control Study (FarbMCI2012)
Primary Purpose
Mild Cognitive Impairment
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cogntive Activation Training
Waitlist Control / Home-based training
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, MCI, Meditation, Mindfulness, Cognitive Activation, Cognitive Training, Tai Chi
Eligibility Criteria
Inclusion Criteria:
- Subjective complaint about decline in memory or attention
- > 1 deviation below age-norm performance on memory or attention tasks
- Independence in daily living
- English speaking
Exclusion Criteria:
- Neurological disorders (including aphasias) or reversible causes of dementia (e.g., hypothyroidism or B12 deficiency)
- Montreal Cognitive Assessment (MOCA) score < 24
- Clinical mood disorder such as depression or anxiety
- Other serious medical conditions that preclude participation in the program
Sites / Locations
- Baycrest
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Waitlist Control / Home-based training
Cognitive Activation Group
Arm Description
This group will serve as a waitlist control group while the active group is performing training. Following assessment at the end of the active group period, this group will begin home-based training and will be assessed at the end of that 10 week period.
This group will attend the 3/week group intervention meetings over 10 weeks.
Outcomes
Primary Outcome Measures
Processing Speed
Processing speed on computerized cognitive task.
Memory
Tests of immediate recall and delayed recall, recognition, and familiarity.
Executive Function
Tests of inhibition, task switching, and problem solving.
Attention / Working Memory
Working memory measures such as digit span, selection of targets among distractors, etc.
Secondary Outcome Measures
Mood and Well-being
Tests of dysphoric affect and subjective quality of life
Daily Function
Tests of instrumental activities of daily living
Full Information
NCT ID
NCT01641328
First Posted
July 12, 2012
Last Updated
July 13, 2012
Sponsor
Rotman Research Institute at Baycrest
Collaborators
Roy Hintsa
1. Study Identification
Unique Protocol Identification Number
NCT01641328
Brief Title
Cognitive Activation Therapy for MCI: A Randomized Control Study
Acronym
FarbMCI2012
Official Title
Phase 1 Study of Cognitive Activation Behavioral Therapy for MCI: A Randomized Waitlist-Control and Delayed Active-Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rotman Research Institute at Baycrest
Collaborators
Roy Hintsa
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mild cognitive impairment (MCI) describes an initial phase of cognitive decline, usually among older adults, in which a person notices a decline in attention or memory, and performs worse than normal on cognitive tests of such. People with MCI are more likely to develop Alzheimer's disease or related dementia than others their same age, and so MCI is thought of as an early warning sign of progressive cognitive decline.
While some forms of MCI may be brought about by purely genetic causes, other cases may be due to a withdrawal of cognitive engagement with the world. In these cases, a rigorous program of cognitive training may be beneficial, halting or reversing symptom progression.
The current study will evaluate a multifaceted cognitive activation program on older adults with MCI. This group program is intensive, running for 10 weeks, 3 times per week, for a total of 100 hours of training. Training consists of meditation exercises for broad attention activation, Tai Chi exercises to integrate cognition with body awareness, and cognitive training through computerized attention, memory, and problem solving exercise.
Subjective impressions and objective measures of cognitive ability will be measured before and after the intervention. The investigators will also examine effects on mood and levels of daily function. Results will be compared to a waitlisted control group. The control group will subsequently be entered into a home-based version of the program for 10 weeks, with assessment before and after training, to look at the importance of the group meeting dynamic in promoting cognitive change.
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, MCI, Meditation, Mindfulness, Cognitive Activation, Cognitive Training, Tai Chi
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Waitlist Control / Home-based training
Arm Type
Active Comparator
Arm Description
This group will serve as a waitlist control group while the active group is performing training. Following assessment at the end of the active group period, this group will begin home-based training and will be assessed at the end of that 10 week period.
Arm Title
Cognitive Activation Group
Arm Type
Experimental
Arm Description
This group will attend the 3/week group intervention meetings over 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cogntive Activation Training
Other Intervention Name(s)
Computer-based cognitive training is provided by Lumosity
Intervention Description
Mindfulness-based stress reduction - 30 minutes / class x 3 classes / week; optional home practice Tai Chi - 30 minutes / class x 3 classes / week; optional home practice Computer-based cognitive training - 20 minutes / class x 3 classes / week; optional home practice
Intervention Type
Behavioral
Intervention Name(s)
Waitlist Control / Home-based training
Other Intervention Name(s)
Computer-based cognitive training is provided by Lumosity, Biofeedback relaxation training is provided by HeartMath
Intervention Description
Computer-based cognitive training - 20 minutes / day Daily walking - 20 minutes / day Biofeedback relaxation Training - 20 minutes / day
Primary Outcome Measure Information:
Title
Processing Speed
Description
Processing speed on computerized cognitive task.
Time Frame
Before and After Intervention
Title
Memory
Description
Tests of immediate recall and delayed recall, recognition, and familiarity.
Time Frame
Before and After Intervention
Title
Executive Function
Description
Tests of inhibition, task switching, and problem solving.
Time Frame
Before and After Intervention
Title
Attention / Working Memory
Description
Working memory measures such as digit span, selection of targets among distractors, etc.
Time Frame
Before and after intervention
Secondary Outcome Measure Information:
Title
Mood and Well-being
Description
Tests of dysphoric affect and subjective quality of life
Time Frame
Before and after intervention
Title
Daily Function
Description
Tests of instrumental activities of daily living
Time Frame
Before and after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjective complaint about decline in memory or attention
> 1 deviation below age-norm performance on memory or attention tasks
Independence in daily living
English speaking
Exclusion Criteria:
Neurological disorders (including aphasias) or reversible causes of dementia (e.g., hypothyroidism or B12 deficiency)
Montreal Cognitive Assessment (MOCA) score < 24
Clinical mood disorder such as depression or anxiety
Other serious medical conditions that preclude participation in the program
Facility Information:
Facility Name
Baycrest
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A2E1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norman AS Farb, PhD
Phone
416-785-2500
Ext
2737
Email
nfarb@research.baycrest.org
First Name & Middle Initial & Last Name & Degree
Norman AS Farb, PhD
12. IPD Sharing Statement
Links:
URL
http://research.baycrest.org/
Description
Related info about Baycrest and the Rotman Research Institute
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Cognitive Activation Therapy for MCI: A Randomized Control Study
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