FarbMCI2012: Cognitive Activation Therapy for MCI: A Randomized Control Study

Sponsor
Rotman Research Institute at Baycrest (Other)
Overall Status
Unknown status
CT.gov ID
NCT01641328
Collaborator
Roy Hintsa (Other)
30
1
2
9
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cogntive Activation Training
  • Behavioral: Waitlist Control / Home-based training
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1 Study of Cognitive Activation Behavioral Therapy for MCI: A Randomized Waitlist-Control and Delayed Active-Control Study
Study Start Date :
Oct 1, 2012
Anticipated Primary Completion Date :
Mar 1, 2013
Anticipated Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Waitlist Control / Home-based training

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
Computer-based cognitive training - 20 minutes / day Daily walking - 20 minutes / day Biofeedback relaxation Training - 20 minutes / day
Other Names:
  • Computer-based cognitive training is provided by Lumosity
  • Biofeedback relaxation training is provided by HeartMath
  • Experimental: Cognitive Activation Group

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

    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
    Other Names:
  • Computer-based cognitive training is provided by Lumosity
  • Outcome Measures

    Primary Outcome Measures

    1. Processing Speed [Before and After Intervention]

      Processing speed on computerized cognitive task.

    2. Memory [Before and After Intervention]

      Tests of immediate recall and delayed recall, recognition, and familiarity.

    3. Executive Function [Before and After Intervention]

      Tests of inhibition, task switching, and problem solving.

    4. Attention / Working Memory [Before and after intervention]

      Working memory measures such as digit span, selection of targets among distractors, etc.

    Secondary Outcome Measures

    1. Mood and Well-being [Before and after intervention]

      Tests of dysphoric affect and subjective quality of life

    2. Daily Function [Before and after intervention]

      Tests of instrumental activities of daily living

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baycrest Toronto Ontario Canada M6A2E1

    Sponsors and Collaborators

    • Rotman Research Institute at Baycrest
    • Roy Hintsa

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Norman Farb, Postdoctoral Fellow, Rotman Research Institute at Baycrest
    ClinicalTrials.gov Identifier:
    NCT01641328
    Other Study ID Numbers:
    • RRI_Farb_001
    First Posted:
    Jul 16, 2012
    Last Update Posted:
    Jul 16, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by Norman Farb, Postdoctoral Fellow, Rotman Research Institute at Baycrest
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 16, 2012