Mild Cognitive ImpairmentPhase 2NCT00285753
Support Groups for Patients With Mild Cognitive Impairment and Their Partners
A Phase 2 study testing support groups in people with Mild Cognitive Impairment, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
This study aims at developing and evaluating a support group program for patients with mild cognitive impairment (MCI) and their partners. These patients have defective memory function but are not demented. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- support groups
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 110 participants
- Where
- 2 sitesNetherlands
- Study dates
- Nov 2003to Oct 2007
- Phase
- Phase 2
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with MCI (MCI criteria, Petersen, 2001 and Grundman, 2004) and their primary caregivers.
Who cannot join
- Mini-Mental State Examination (MMSE) < 23
- Severe mood disorder.
- No motivation.
- Severe language problems.
- Premorbid relationship problems
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Rijnstate Ziekenhuis
Arnhem, Gelderland
UMC Sint Radboud
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Development and Evaluation of Support Groups for Patients With Mild Cognitive Impairment and Their Partners
This study aims at developing and evaluating a support group program for patients with mild cognitive impairment (MCI) and their partners. These patients have defective memory function but are not demented. However, there is an increased chance of developing dementia in the near future; 10-15% per year for MCI patients, in contrast to 1-2% per year for healthy elderly persons. For the patients and their caregivers this means that they are confronted with feelings of uncertainty and fear towards the future. They also have many questions about how to improve their memory problems and how to cope with other changes or consequences.
The purpose of the support group program is to improve coping skills and facilitate adaptation to the impairments, in order to reduce anxiety or depression and strengthen feelings of competence in patients and their partners.
Read the detailed description
One of the consequences of the improved methodology for diagnosing dementia in a very early stage is a growing group of patients in memory clinics who have cognitive deficits, which exceed normal physiological aging processes but do not fulfil the criteria for dementia. This category of patients with so-called 'Mild cognitive impairment' (MCI) is known to have an increased risk at developing Dementia. For these patients, who have intact insight and expressive skills, we expect that a psychosocial intervention may reduce feelings of helplessness and anxiety and improve quality of life.
The group intervention was developed with respect to the 'stress adaptation coping model' of Lazarus and the 'family support model' of Bengston and Kuypers.
Coming up with these models the aim is to teach participants to explore their attributions, feelings and behaviour in order to enhance their coping strategies. This will increase the feelings of competence and decrease feelings of helplessness.
In addition to these models we investigated the problems and themes as they are experienced by MCI patients and their partners, using systematic interviews. This information resulted in the following modules:
- Understanding MCI and memory problems;
- Exploring attributions and misconceptions;
- Other changes;
- Methods to improve memory performance;
- Worrying and problem solving;
- Losing activities and finding a new balance;
- Tension and relaxation;
- Managing conflicts;
- Emotions.
These modules are worked through in 10 sessions, in 12 weeks. The group structure is as follows: patients and parents meet separately the first 60 minutes, and then reconvene together for the last half hour. This structure optimizes the sharing of each other's experiences and prevents stigmatizing.
The main objective of the current study is to develop and evaluate a support group intervention for patients with MCI and their partners. We expect that our support group intervention will strengthen the partner's sense of competence to care for the patient and will improve the quality of life of the patient and the partner as well.
- Conditions
- Mild Cognitive Impairment
- Being tested
- support groups
- Keywords
- psychosocial intervention, mild cognitive impairment, support group, caregivers, Mild Cognitive Impairment (MCI), Cognitive Impairment No Dementia (CIND)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
support groupsBehavioural
cognitive behavioral intervention with psychoeducation
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life: RAND, GDS
Measured: pre and post treatment
caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP)
Measured: pre- and post intervention
Secondary outcomes (2)
Illness cognitions: Illness Cognitions Questionnaire (ICQ)
Measured: pre and post treatment
marital satisfaction: Maudsley Marital Questionnaire (MMQ)
Measured: pre and post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startNov 2003
- Primary completionOct 2007
- Study completionOct 2007
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.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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 2
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Alzheimer Foundation
- Investigators
- Jan Pieter Teunisse, PhD, Principal investigator, Radboud University Medical CenterFloor Kraaimaat, Professor, Principal investigator, Radboud University Medical CenterMarcel Olde Rikkert, Professor, Principal investigator, Coordinator Alzheimer Centre UMC NijmegenMyrra Vernooy, PhD, Principal investigator, Coordinator Alzheimer Centre UMC Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285753
- Sponsor's protocol ID
- V-2002-018
- Other IDs
- CMO-nr: 2003/071
- Status last verified
- May 2008
- First submitted
- 1 Feb 2006
- Last updated
- 21 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Banningh LW, Vernooij-Dassen MJ, Vullings M, Prins JB, Rikkert MG, Kessels RP. Learning to live with a loved one with mild cognitive impairment: effectiveness of a waiting list controlled trial of a group intervention on significant others' sense of competence and well-being. Am J Alzheimers Dis Other Demen. 2013 May;28(3):228-38. doi: 10.1177/1533317513481093. Epub 2013 Mar 25.
PubMed 23528880Joosten-Weyn Banningh LW, Prins JB, Vernooij-Dassen MJ, Wijnen HH, Olde Rikkert MG, Kessels RP. Group therapy for patients with mild cognitive impairment and their significant others: results of a waiting-list controlled trial. Gerontology. 2011;57(5):444-54. doi: 10.1159/000315933. Epub 2010 Jul 20.
PubMed 20664181
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Support Groups for Patients With Mild Cognitive Impairment and Their Partners
- ClinicalTrials.gov ID
- NCT00285753
- Acronym / sponsor ID
- V-2002-018
- Conditions
- Mild Cognitive Impairment
- Keywords
- psychosocial intervention, mild cognitive impairment, support group, caregivers, Mild Cognitive Impairment (MCI), Cognitive Impairment No Dementia (CIND)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Alzheimer Foundation
- Study start
- Nov 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 2 Feb 2006 (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.
This study aims at developing and evaluating a support group program for patients with mild cognitive impairment (MCI) and their partners. These patients have defective memory function but are not demented. However, there is an increased chance of developing dementia in the near future; 10-15% per year for MCI patients, in contrast to 1-2% per year for healthy elderly persons. For the patients and their caregivers this means that they are confronted with feelings of uncertainty and fear towards the future. They also have many questions about how to improve their memory problems and how to cope with other changes or consequences.
The purpose of the support group program is to improve coping skills and facilitate adaptation to the impairments, in order to reduce anxiety or depression and strengthen feelings of competence in patients and their partners.
Detailed description
One of the consequences of the improved methodology for diagnosing dementia in a very early stage is a growing group of patients in memory clinics who have cognitive deficits, which exceed normal physiological aging processes but do not fulfil the criteria for dementia. This category of patients with so-called 'Mild cognitive impairment' (MCI) is known to have an increased risk at developing Dementia. For these patients, who have intact insight and expressive skills, we expect that a psychosocial intervention may reduce feelings of helplessness and anxiety and improve quality of life.
The group intervention was developed with respect to the 'stress adaptation coping model' of Lazarus and the 'family support model' of Bengston and Kuypers.
Coming up with these models the aim is to teach participants to explore their attributions, feelings and behaviour in order to enhance their coping strategies. This will increase the feelings of competence and decrease feelings of helplessness.
In addition to these models we investigated the problems and themes as they are experienced by MCI patients and their partners, using systematic interviews. This information resulted in the following modules:
- Understanding MCI and memory problems;
- Exploring attributions and misconceptions;
- Other changes;
- Methods to improve memory performance;
- Worrying and problem solving;
- Losing activities and finding a new balance;
- Tension and relaxation;
- Managing conflicts;
- Emotions.
These modules are worked through in 10 sessions, in 12 weeks. The group structure is as follows: patients and parents meet separately the first 60 minutes, and then reconvene together for the last half hour. This structure optimizes the sharing of each other's experiences and prevents stigmatizing.
The main objective of the current study is to develop and evaluate a support group intervention for patients with MCI and their partners. We expect that our support group intervention will strengthen the partner's sense of competence to care for the patient and will improve the quality of life of the patient and the partner as well.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with MCI (MCI criteria, Petersen, 2001 and Grundman, 2004) and their primary caregivers.
Key exclusion criteria (5 listed)
- Mini-Mental State Examination (MMSE) < 23
- Severe mood disorder.
- No motivation.
- Severe language problems.
- Premorbid relationship problems
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 |
|---|---|---|
| support groupscognitive behavioral intervention with psychoeducation | Behavioural | – |
Primary outcome
quality of life: RAND, GDS
Time frame: pre and post treatment
caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP)
Time frame: pre- and post intervention
2 secondary outcomes
Illness cognitions: Illness Cognitions Questionnaire (ICQ)
Time frame: pre and post treatment
marital satisfaction: Maudsley Marital Questionnaire (MMQ)
Time frame: pre and post treatment
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 21 May 2008.
- Derived from this study: PubMed 23528880Banningh LW, Vernooij-Dassen MJ, Vullings M, Prins JB, Rikkert MG, Kessels RP. Learning to live with a loved one with mild cognitive impairment: effectiveness of a waiting list controlled trial of a group intervention on significant others' sense of competence and well-being. Am J Alzheimers Dis Other Demen. 2013 May;28(3):228-38. doi: 10.1177/1533317513481093. Epub 2013 Mar 25.
- Derived from this study: PubMed 20664181Joosten-Weyn Banningh LW, Prins JB, Vernooij-Dassen MJ, Wijnen HH, Olde Rikkert MG, Kessels RP. Group therapy for patients with mild cognitive impairment and their significant others: results of a waiting-list controlled trial. Gerontology. 2011;57(5):444-54. doi: 10.1159/000315933. Epub 2010 Jul 20.
Related trials for Mild Cognitive Impairment
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
Enrolling by invitation
Mild Cognitive Impairment and Neuromodulation
Mild Cognitive Impairment (MCI)
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.
Jan Pieter Teunisse, PhD principal investigator
Radboud University Medical Center
Floor Kraaimaat, Professor principal investigator
Radboud University Medical Center
Marcel Olde Rikkert, Professor principal investigator
Coordinator Alzheimer Centre UMC Nijmegen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing support groups in people with Mild Cognitive Impairment, run by Radboud University Medical Center at 2 sites in Netherlands.
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 1 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 21 May 2008. 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 Netherlands. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
quality of life: RAND, GDS (time frame: pre and post treatment). The study lists 2 primary outcomes in all. 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 NCT00285753, 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 21 May 2008.