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

July 13, 2012 updated by: Norman Farb, Rotman Research Institute at Baycrest

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6A2E1
        • Baycrest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Processing Speed
Time Frame: Before and After Intervention
Processing speed on computerized cognitive task.
Before and After Intervention
Memory
Time Frame: Before and After Intervention
Tests of immediate recall and delayed recall, recognition, and familiarity.
Before and After Intervention
Executive Function
Time Frame: Before and After Intervention
Tests of inhibition, task switching, and problem solving.
Before and After Intervention
Attention / Working Memory
Time Frame: Before and after intervention
Working memory measures such as digit span, selection of targets among distractors, etc.
Before and after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood and Well-being
Time Frame: Before and after intervention
Tests of dysphoric affect and subjective quality of life
Before and after intervention
Daily Function
Time Frame: Before and after intervention
Tests of instrumental activities of daily living
Before and after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rotman Research Institute at Baycrest

Collaborators

Roy Hintsa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 13, 2012

First Posted (Estimate)

July 16, 2012

Study Record Updates

Last Update Posted (Estimate)

July 16, 2012

Last Update Submitted That Met QC Criteria

July 13, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRI_Farb_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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