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Cognitive Activation Therapy for MCI: A Randomized Control Study

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01641328
Acronym
FarbMCI2012
Enrollment
30
Registered
2012-07-16
Start date
2012-10-31
Completion date
2013-07-31
Last updated
2012-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment, MCI, Meditation, Mindfulness, Cognitive Activation, Cognitive Training, Tai Chi

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.

Interventions

BEHAVIORALCogntive Activation Training

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

BEHAVIORALWaitlist Control / Home-based training

Computer-based cognitive training - 20 minutes / day Daily walking - 20 minutes / day Biofeedback relaxation Training - 20 minutes / day

Sponsors

Roy Hintsa
CollaboratorUNKNOWN
Rotman Research Institute at Baycrest
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Processing SpeedBefore and After InterventionProcessing speed on computerized cognitive task.
MemoryBefore and After InterventionTests of immediate recall and delayed recall, recognition, and familiarity.
Executive FunctionBefore and After InterventionTests of inhibition, task switching, and problem solving.
Attention / Working MemoryBefore and after interventionWorking memory measures such as digit span, selection of targets among distractors, etc.

Secondary

MeasureTime frameDescription
Mood and Well-beingBefore and after interventionTests of dysphoric affect and subjective quality of life
Daily FunctionBefore and after interventionTests of instrumental activities of daily living

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026