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Support Groups for Patients With Mild Cognitive Impairment and Their Partners

This study has been completed.
Sponsor:
Collaborator:
Netherlands Alzheimer Foundation
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00285753
First received: February 1, 2006
Last updated: May 20, 2008
Last verified: May 2008
  Purpose

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
Mild Cognitive Impairment
Behavioral: support groups
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Development and Evaluation of Support Groups for Patients With Mild Cognitive Impairment and Their Partners

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • quality of life: RAND, GDS [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP) [ Time Frame: pre- and post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Illness cognitions: Illness Cognitions Questionnaire (ICQ) [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • marital satisfaction: Maudsley Marital Questionnaire (MMQ) [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Behavioral: support groups
    cognitive behavioral intervention with psychoeducation
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285753

Locations
Netherlands
Rijnstate Ziekenhuis
Arnhem, Gelderland, Netherlands
UMC Sint Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Netherlands Alzheimer Foundation
Investigators
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
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of medical psychology, UMCN St. radboud
ClinicalTrials.gov Identifier: NCT00285753     History of Changes
Other Study ID Numbers: V-2002-018, CMO-nr: 2003/071
Study First Received: February 1, 2006
Last Updated: May 20, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
psychosocial intervention
mild cognitive impairment
support group
caregivers
Mild Cognitive Impairment (MCI)
Cognitive Impairment No Dementia (CIND)

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014