Cognitive Activation Therapy for MCI: A Randomized Control Study

Mild Cognitive Impairment Clinical Trial

— FarbMCI2012  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01641328
• Other study ID #: RRI_Farb_001
• Status: Not yet recruiting
• Phase: Phase 1
• First received: July 12, 2012
• Last updated: July 13, 2012
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2012
• Source: Rotman Research Institute at Baycrest
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Behavioral:
• Cogntive 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
• Waitlist Control / Home-based training
Computer-based cognitive training - 20 minutes / day Daily walking - 20 minutes / day Biofeedback relaxation Training - 20 minutes / day

Locations

Country	Name	City	State
Canada	Baycrest	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Rotman Research Institute at Baycrest	Roy Hintsa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Processing Speed	Processing speed on computerized cognitive task.	Before and After Intervention	No
Primary	Memory	Tests of immediate recall and delayed recall, recognition, and familiarity.	Before and After Intervention	No
Primary	Executive Function	Tests of inhibition, task switching, and problem solving.	Before and After Intervention	No
Primary	Attention / Working Memory	Working memory measures such as digit span, selection of targets among distractors, etc.	Before and after intervention	No
Secondary	Mood and Well-being	Tests of dysphoric affect and subjective quality of life	Before and after intervention	No
Secondary	Daily Function	Tests of instrumental activities of daily living	Before and after intervention	No

External Links

•   Related info about Baycrest and the Rotman Research Institute