Cognitive Activation Therapy for MCI: A Randomized Control Study

Study Overview
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Brief Summary
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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.

Official Title
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Phase 1 Study of Cognitive Activation Behavioral Therapy for MCI: A Randomized Waitlist-Control and Delayed Active-Control Study

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Cogntive Activation Training
* Behavioral: Waitlist Control / Home-based training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Waitlist Control / Home-based training<br>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. | Behavioral: Waitlist Control / Home-based training<br>* Computer-based cognitive training - 20 minutes / day Daily walking - 20 minutes / day Biofeedback relaxation Training - 20 minutes / day<br>* Other names: Biofeedback relaxation training is provided by HeartMath;|
| Experimental: Cognitive Activation Group<br>This group will attend the 3/week group intervention meetings over 10 weeks. | Behavioral: Cogntive Activation Training<br>* 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<br>* Other names: Computer-based cognitive training is provided by Lumosity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Processing Speed | Processing speed on computerized cognitive task. | Before and After Intervention | 
| Memory | Tests of immediate recall and delayed recall, recognition, and familiarity. | Before and After Intervention | 
| Executive Function | Tests of inhibition, task switching, and problem solving. | Before and After Intervention | 
| Attention / Working Memory | Working memory measures such as digit span, selection of targets among distractors, etc. | Before and after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood and Well-being | Tests of dysphoric affect and subjective quality of life | Before and after intervention | 
| Daily Function | Tests of instrumental activities of daily living | Before and after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Cognitive Impairment, MCI, Meditation, Mindfulness, Cognitive Activation, Cognitive Training, Tai Chi