Clinical trial NCT01641328: Cognitive Activation Therapy for MCI: A Randomized Control Study
Official title: Phase 1 Study of Cognitive Activation Behavioral Therapy for MCI: A Randomized Waitlist-Control and Delayed Active-Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
MCI
Meditation
Mindfulness
Cognitive Activation
Cognitive Training
Tai Chi
Lead sponsor: Rotman Research Institute at Baycrest
Sponsor class: OTHER
Collaborators: name: Roy Hintsa
First posted: 2012-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Processing Speed
timeFrame: Before and After Intervention
measure: Memory
timeFrame: Before and After Intervention
measure: Executive Function
timeFrame: Before and After Intervention
measure: Attention / Working Memory
timeFrame: Before and after intervention
Secondary outcomes:
measure: Mood and Well-being
timeFrame: Before and after intervention
measure: Daily Function
timeFrame: Before and after intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest
state: Ontario
Study officials:
References: