Cognitive Activation Therapy for MCI: A Randomized Control Study

NCT01641328 | Unknown Phase 1

• 1 other identifier: RRI_Farb_001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Mood and Well-being

  Before and after intervention

• Daily Function

  Before and after intervention

Study Arms (2)

Waitlist Control / Home-based training

ACTIVE COMPARATOR

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

Cognitive Activation Group

EXPERIMENTAL

This group will attend the 3/week group intervention meetings over 10 weeks.

Behavioral: Cogntive Activation Training

Interventions

Cogntive Activation Training BEHAVIORAL

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

Also known as: Computer-based cognitive training is provided by Lumosity

Cognitive Activation Group

Waitlist Control / Home-based training BEHAVIORAL

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

Also known as: Computer-based cognitive training is provided by Lumosity, Biofeedback relaxation training is provided by HeartMath

Waitlist Control / Home-based training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rotman Research Institute at Baycrest: lead
• Roy Hintsa: collaborator

Study Sites (1)

Baycrest

Toronto, Ontario, M6A2E1, Canada

Location

Related Links

• Related info about Baycrest and the Rotman Research Institute

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 16, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 16, 2012

Record last verified: 2012-07

Locations

CA (1)