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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01448148
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : January 27, 2016
Laval University
Information provided by (Responsible Party):
Sylvie Belleville, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Brief Summary:

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 or disease Intervention/treatment Phase
Mild Cognitive Impairment Other: Cognitive intervention Other: Psychosocial intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Measuring the Impact of Cognitive and Psychosocial Interventions in Persons With Mild Cognitive Impairment
Study Start Date : November 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Cognitive intervention
Use of Memo protocol for 8 weeks
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
Use of "Programme d'intervention psychosociale axé sur le bien-être psychologique" for 8 weeks
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
waiting list

Primary Outcome Measures :
  1. Change in memory measures [ Time Frame: one week before and after intervention, and three and six months later ]
    Unrelated word list learning and Face-name memory tests

Secondary Outcome Measures :
  1. generalization of therapeutic gains to everyday life [ Time Frame: one week before and after intervention, and three and six months later ]
    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.

  2. Change in psychological health measures [ Time Frame: one week before and after intervention, and 3 and 6 months later ]
    geriatric anxiety inventory, griatric depression scale and general well-being schedule tests

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01448148

Canada, Quebec
Centre de recherche de l'Institut universitaire de geriatrie de Montreal
Montreal, Quebec, Canada, H3W 1W5
Centre hospitalier Robert-Giffard
Quebec, Canada, G1J 2G3
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Laval University
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

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 Identifier: NCT01448148     History of Changes
Other Study ID Numbers: CRIUGM-002
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016

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

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders