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

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive intervention
Psychosocial intervention
Sponsored by
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de recherche de l'Institut universitaire de geriatrie de Montreal
  • Centre hospitalier Robert-Giffard

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Cognitive intervention

Psychosocial intervention

no contact control group

Arm Description

Use of Memo protocol for 8 weeks

Use of "Programme d'intervention psychosociale axé sur le bien-être psychologique" for 8 weeks

waiting list

Outcomes

Primary Outcome Measures

Change in memory measures
Unrelated word list learning and Face-name memory tests

Secondary Outcome Measures

generalization of therapeutic gains to everyday life
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
geriatric anxiety inventory, griatric depression scale and general well-being schedule tests

Full Information

First Posted
September 28, 2011
Last Updated
January 26, 2016
Sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Collaborators
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT01448148
Brief Title
Measuring the Impact of Cognitive and Psychosocial Interventions in Persons With Mild Cognitive Impairment
Official Title
Measuring the Impact of Cognitive and Psychosocial Interventions in Persons With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Collaborators
Laval University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild cognitive impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive intervention
Arm Type
Experimental
Arm Description
Use of Memo protocol for 8 weeks
Arm Title
Psychosocial intervention
Arm Type
Experimental
Arm Description
Use of "Programme d'intervention psychosociale axé sur le bien-être psychologique" for 8 weeks
Arm Title
no contact control group
Arm Type
No Intervention
Arm Description
waiting list
Intervention Type
Other
Intervention Name(s)
Cognitive intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Psychosocial intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in memory measures
Description
Unrelated word list learning and Face-name memory tests
Time Frame
one week before and after intervention, and three and six months later
Secondary Outcome Measure Information:
Title
generalization of therapeutic gains to everyday life
Description
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.
Time Frame
one week before and after intervention, and three and six months later
Title
Change in psychological health measures
Description
geriatric anxiety inventory, griatric depression scale and general well-being schedule tests
Time Frame
one week before and after intervention, and 3 and 6 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Belleville, Ph.D.
Organizational Affiliation
Centre de recherche Institut universitaire de geriatrie de Montreal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carol Hudon, Ph.D.
Organizational Affiliation
Laval University, Psychology department
Official's Role
Study Director
Facility Information:
Facility Name
Centre de recherche de l'Institut universitaire de geriatrie de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3W 1W5
Country
Canada
Facility Name
Centre hospitalier Robert-Giffard
City
Quebec
ZIP/Postal Code
G1J 2G3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17050952
Citation
Belleville S, Gilbert B, Fontaine F, Gagnon L, Menard E, Gauthier S. Improvement of episodic memory in persons with mild cognitive impairment and healthy older adults: evidence from a cognitive intervention program. Dement Geriatr Cogn Disord. 2006;22(5-6):486-99. doi: 10.1159/000096316. Epub 2006 Oct 16.
Results Reference
background
PubMed Identifier
17958927
Citation
Belleville S. Cognitive training for persons with mild cognitive impairment. Int Psychogeriatr. 2008 Feb;20(1):57-66. doi: 10.1017/S104161020700631X. Epub 2007 Oct 25.
Results Reference
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Measuring the Impact of Cognitive and Psychosocial Interventions in Persons With Mild Cognitive Impairment

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