Mild Cognitive ImpairmentNCT01448148
Measuring the Impact of Cognitive and Psychosocial Interventions in Persons With Mild Cognitive Impairment
A study testing Cognitive intervention and Psychosocial intervention in people with Mild Cognitive Impairment, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Cognitive intervention and Psychosocial intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2011to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- francophone
- MCI identified by a doctor
- normal corrected vision
- good hearing
Who cannot join
- history of neurological disorder
- major psychiatric illness
- alcoholism
- general anesthesia in the previous six months
- significant impairment of physical mobility
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre de recherche de l'Institut universitaire de geriatrie de Montreal
Montreal, Quebec, H3W 1W5
Centre hospitalier Robert-Giffard
Québec, Quebec, G1J 2G3
About this study
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Cognitive intervention, Psychosocial intervention
- Keywords
- Mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive intervention | Experimental | Use of Memo protocol for 8 weeks Receives: Other: Cognitive intervention |
| Psychosocial intervention | Experimental | Use of "Programme d'intervention psychosociale axé sur le bien-être psychologique" for 8 weeks Receives: Other: Psychosocial intervention |
| no contact control group | No intervention | waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in memory measures
Unrelated word list learning and Face-name memory tests
Measured: one week before and after intervention, and three and six months later
Secondary outcomes (2)
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.
Measured: one week before and after intervention, and three and six months later
Change in psychological health measures
geriatric anxiety inventory, griatric depression scale and general well-being schedule tests
Measured: one week before and after intervention, and 3 and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University
- Responsible party
- Principal investigator, Sylvie Belleville, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Investigators
- Sylvie Belleville, Ph.D., Principal investigator, Centre de recherche Institut universitaire de geriatrie de MontrealCarol Hudon, Ph.D., Study director, Laval University, Psychology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448148
- Sponsor's protocol ID
- CRIUGM-002
- Status last verified
- Jan 2016
- First submitted
- 28 Sep 2011
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17050952Belleville 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.
PubMed 17958927
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of Cognitive and Psychosocial Interventions in Persons With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01448148
- Acronym / sponsor ID
- CRIUGM-002
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealUniversity, hospital or other
- Collaborators
- Laval University
- Study start
- Nov 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive intervention | Experimental | Other: Cognitive interventionUse of Memo protocol for 8 weeks |
| Psychosocial intervention | Experimental | Other: Psychosocial interventionUse of "Programme d'intervention psychosociale axé sur le bien-être psychologique" for 8 weeks |
| no contact control group | No intervention | –waiting list |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- francophone
- MCI identified by a doctor
- normal corrected vision
- good hearing
Key exclusion criteria (5 listed)
- history of neurological disorder
- major psychiatric illness
- alcoholism
- general anesthesia in the previous six months
- significant impairment of physical mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive interventionDifferent 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. | Other | Cognitive intervention |
| Psychosocial interventionBased on a cognitive-behavioural approach, the psychosocial intervention will aim at improving general psychological well-being or preventing psychological distress in persons with MCI. | Other | Psychosocial intervention |
Primary outcome
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
2 secondary outcomes
generalization of therapeutic gains to everyday life
Time frame: one week before and after intervention, and three and six months later
Change in psychological health measures
Time frame: one week before and after intervention, and 3 and 6 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Background: PubMed 17050952Belleville 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.
- Background: PubMed 17958927Belleville 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Belleville, Ph.D. principal investigator
Centre de recherche Institut universitaire de geriatrie de Montreal
Carol Hudon, Ph.D. study director
Laval University, Psychology department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive intervention and Psychosocial intervention in people with Mild Cognitive Impairment, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in memory measures (time frame: one week before and after intervention, and three and six months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01448148, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.