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Support Groups for Patients With Mild Cognitive Impairment and Their Partners

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00285753
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : May 21, 2008
Netherlands Alzheimer Foundation
Information provided by:
Radboud University

Brief 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. 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 or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: support groups Phase 2

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:

  1. Understanding MCI and memory problems;
  2. Exploring attributions and misconceptions;
  3. Other changes;
  4. Methods to improve memory performance;
  5. Worrying and problem solving;
  6. Losing activities and finding a new balance;
  7. Tension and relaxation;
  8. Managing conflicts;
  9. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Development and Evaluation of Support Groups for Patients With Mild Cognitive Impairment and Their Partners
Study Start Date : November 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Intervention Details:
  • Behavioral: support groups
    cognitive behavioral intervention with psychoeducation

Primary Outcome Measures :
  1. quality of life: RAND, GDS [ Time Frame: pre and post treatment ]
  2. caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP) [ Time Frame: pre- and post intervention ]

Secondary Outcome Measures :
  1. Illness cognitions: Illness Cognitions Questionnaire (ICQ) [ Time Frame: pre and post treatment ]
  2. marital satisfaction: Maudsley Marital Questionnaire (MMQ) [ Time Frame: pre and post treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with MCI (MCI criteria, Petersen, 2001 and Grundman, 2004) and their primary caregivers.

Exclusion Criteria:

  • Mini-Mental State Examination (MMSE) < 23
  • Severe mood disorder.
  • No motivation.
  • Severe language problems.
  • Premorbid relationship problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00285753

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Rijnstate Ziekenhuis
Arnhem, Gelderland, Netherlands
UMC Sint Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Netherlands Alzheimer Foundation
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Department of medical psychology, UMCN St. radboud Identifier: NCT00285753    
Other Study ID Numbers: V-2002-018
CMO-nr: 2003/071
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: May 21, 2008
Last Verified: May 2008
Keywords provided by Radboud University:
psychosocial intervention
mild cognitive impairment
support group
Mild Cognitive Impairment (MCI)
Cognitive Impairment No Dementia (CIND)
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders