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Sponsors and Collaborators: |
Radboud University Stichting Alzheimer Nederland |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00285753 |
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.
Condition | Intervention | Phase |
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Mild Cognitive Impairment |
Behavioral: support groups |
Phase II |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Development and Evaluation of Support Groups for Patients With Mild Cognitive Impairment and Their Partners |
Enrollment: | 110 |
Study Start Date: | November 2003 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
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:
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.
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Netherlands, Gelderland | |
UMC Sint Radboud | |
Nijmegen, Gelderland, Netherlands, 6500 HB | |
Rijnstate Ziekenhuis | |
Arnhem, Gelderland, Netherlands |
Principal Investigator: | Jan Pieter Teunisse, PhD | Radboud University |
Principal Investigator: | Floor Kraaimaat, Professor | Radboud University |
Principal Investigator: | Marcel Olde Rikkert, Professor | Coordinator Alzheimer Centre UMC Nijmegen |
Principal Investigator: | Myrra Vernooy, PhD | Coordinator Alzheimer Centre UMC Nijmegen |
Responsible Party: | UMCN St. radboud ( Department of medical psychology ) |
Study ID Numbers: | V-2002-018, CMO-nr: 2003/071 |
Study First Received: | February 1, 2006 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00285753 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
psychosocial intervention mild cognitive impairment support group |
caregivers Mild Cognitive Impairment (MCI) Cognitive Impairment No Dementia (CIND) |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Cognition Disorders |