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Measuring the Impact of Cognitive and Psychosocial Interventions in Persons With Mild Cognitive Impairment

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor:
Collaborator:
Laval University
Information provided by (Responsible Party):
Sylvie Belleville, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
ClinicalTrials.gov Identifier:
NCT01448148
First received: September 28, 2011
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

Memory interventions are training programs that provide a variety of cognitive and psychological strategies meant to improve memory. These interventions have been shown to yield significant benefits to normal aged persons and small-size studies have shown that they are suitable and beneficial for persons with mild cognitive impairment. The goal of this proposal is to assess with a well-controlled design the efficiency and specificity of cognitive training in persons with mild cognitive impairment.

The hypothesis is that cognitive training can improve the cognition of persons with mild cognitive impairment and that this improvement can be enduring.


Condition Intervention
Mild Cognitive Impairment
Other: Cognitive intervention
Other: Psychosocial intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Measuring the Impact of Cognitive and Psychosocial Interventions in Persons With Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:

Primary Outcome Measures:
  • Change in memory measures [ Time Frame: one week before and after intervention, and three and six months later ] [ Designated as safety issue: No ]
    Unrelated word list learning and Face-name memory tests


Secondary Outcome Measures:
  • generalization of therapeutic gains to everyday life [ Time Frame: one week before and after intervention, and three and six months later ] [ Designated as safety issue: No ]
    Self-Evaluation Complaints Questionnaire, Activities of Daily Living- Prevention Instrument questionnaire, Multifactorial Memory Questionnaire tests and participants will be asked to press a button to record each occasion when they use a strategy in their daily lives.

  • Change in psychological health measures [ Time Frame: one week before and after intervention, and 3 and 6 months later ] [ Designated as safety issue: No ]
    geriatric anxiety inventory, griatric depression scale and general well-being schedule tests


Estimated Enrollment: 162
Study Start Date: November 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive intervention Other: Cognitive intervention
Different strategies will be included to improve episodic memory. Training on imagery will be provided prior to episodic training.Particular attention will be paid to memory self-efficacy and the negative perception that elderly individuals entertain about memory tasks. The issue of generalization is of major importance in cognitive therapy.
Experimental: Psychosocial intervention Other: Psychosocial intervention
Based on a cognitive-behavioural approach, the psychosocial intervention will aim at improving general psychological well-being or preventing psychological distress in persons with MCI.
No Intervention: no contact control group

Detailed Description:

Elderly persons with mild cognitive impairment experience a cognitive decline that is confirmed by a neuropsychological examination but do not meet the clinical criteria for dementia. However, longitudinal studies have shown that up to 75% of these persons develop dementia of the Alzheimer type after 5 years of follow-up. A significant proportion of these persons are thus in a prodromal phase of the disease. This phase is likely to represent a key moment in which to apply appropriate interventions. Indeed, these persons have the cognitive capabilities to benefit from such interventions. Cognitive training has been shown to be effective in improving the memory function of older persons without cognitive decline and increasing evidence indicates that persons with MCI might also benefit from such interventions. However, there is few researches have focused on the Mild Cognitive Impairment population in spite of the fact that they are at-risk of experiencing significant cognitive problems in the next few years while still having the potential to benefit from non-pharmacological interventions. In a number of pilot studies, the investigators compared cognitive and psychosocial intervention to a control intervention in persons with MCI. The participants' performance improved on proximal outcomes and on distal outcomes (activities of daily living). The purpose of this project is to study the efficacy of the cognitive intervention in a larger group of participants, compare it with a non-cognitive intervention, assess the long term maintenance of the improvement and measure the potential implication of cognitive and psychosocial factors.

Persons with Mild Cognitive Impairment will first receive a comprehensive clinical assessment to determine whether they meet the research criteria for Mild Cognitive Impairment. They will then be randomly allocated to one of three groups. One group will receive cognitive training, one group will receive psychosocial intervention and one group will receive no intervention. The two interventions will be offered on a one-session per week basis during an 8-week period. The cognitive intervention will include training of attention and episodic memory. This intervention is based on recently acquired knowledge regarding the nature of the deficits in mild cognitive impairment as well as factors that are known to optimize memory. The psychosocial intervention will focus on goal management. Booster sessions will be offered to the intervention groups after 3 and 6 months. Each intervention will act as social contact control group for the other intervention. The third group will receive no intervention and will be used as a no-contact control group.

All groups will undergo one pre-intervention assessment (1-2 week before beginning of intervention), one post-intervention assessment (1-2 week after end of intervention) and additional assessments one week after before the booster sessions and nine month following end of training. This last assessment will measure long-term retention of training and will assess the degree of change in the clinical profile of patients.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • francophone
  • MCI identified by a doctor
  • normal corrected vision
  • good hearing

Exclusion Criteria:

  • history of neurological disorder
  • major psychiatric illness
  • alcoholism
  • general anesthesia in the previous six months
  • significant impairment of physical mobility
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448148

Contacts
Contact: Emilie Lepage, M.Sc. 514-340-3540 ext 4710 emilie.lepage@criugm.qc.ca
Contact: Samira Mellah, Ph.D. 514-340-3540 ext 4780 samira.mellah@criugm.qc.ca

Locations
Canada, Quebec
Centre de recherche de l'Institut universitaire de geriatrie de Montreal Recruiting
Montreal, Quebec, Canada, H3W 1W5
Contact: Émilie Lepage, M.Sc.    514-340-3540 ext 4710    emilie.lepage@criugm.qc.ca   
Principal Investigator: Sylvie Belleville, Ph.D.         
Canada
Centre hospitalier Robert-Giffard Recruiting
Quebec, Canada, G1J 2G3
Contact: Carol Hudon, Ph.D.    418-656-2131 ext 3745    carol.hudon@crulrg.ulaval.ca   
Principal Investigator: Carol Hudon, Ph.D.         
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Laval University
Investigators
Principal Investigator: Sylvie Belleville, Ph.D. Centre de recherche Institut universitaire de geriatrie de Montreal
Study Director: Carol Hudon, Ph.D. Laval University, Psychology department
  More Information

Publications:
Responsible Party: Sylvie Belleville, Research director of CRIUGM and full professor at University of Montreal, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
ClinicalTrials.gov Identifier: NCT01448148     History of Changes
Other Study ID Numbers: CRIUGM-002
Study First Received: September 28, 2011
Last Updated: August 9, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:
Mild cognitive impairment

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 24, 2014