NCT01448148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

4.2 years

First QC Date

September 28, 2011

Last Update Submit

January 26, 2016

Conditions

Mild Cognitive Impairment

Keywords

Mild cognitive impairment

Outcome Measures

Primary Outcomes (1)

  • Change in memory measures

    Unrelated word list learning and Face-name memory tests

    one week before and after intervention, and three and six months later

Secondary Outcomes (2)

  • generalization of therapeutic gains to everyday life

    one week before and after intervention, and three and six months later

  • Change in psychological health measures

    one week before and after intervention, and 3 and 6 months later

Study Arms (3)

Cognitive intervention

EXPERIMENTAL

Use of Memo protocol for 8 weeks

Other: Cognitive intervention

Psychosocial intervention

EXPERIMENTAL

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

Other: Psychosocial intervention

no contact control group

NO INTERVENTION

waiting list

Interventions

Cognitive interventionOTHER

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.

Cognitive intervention
Psychosocial interventionOTHER

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.

Psychosocial intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • history of neurological disorder
  • major psychiatric illness
  • alcoholism
  • general anesthesia in the previous six months
  • significant impairment of physical mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de recherche de l'Institut universitaire de geriatrie de Montreal

Montreal, Quebec, H3W 1W5, Canada

Location

Centre hospitalier Robert-Giffard

Québec, Quebec, G1J 2G3, Canada

Location

Related Publications (2)

  • 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.

    PMID: 17050952BACKGROUND

  • 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.

    PMID: 17958927BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sylvie Belleville, Ph.D.

    Centre de recherche Institut universitaire de geriatrie de Montreal

    PRINCIPAL INVESTIGATOR

  • Carol Hudon, Ph.D.

    Laval University, Psychology department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research director of CRIUGM and full professor at University of Montreal

Study Record Dates

First Submitted

September 28, 2011

First Posted

October 7, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

CA(2)