Support Groups for Patients With Mild Cognitive Impairment and Their Partners

May 20, 2008 updated by: Radboud University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands
        • Rijnstate Ziekenhuis
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • UMC Sint Radboud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quality of life: RAND, GDS
Time Frame: pre and post treatment
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
pre- and post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Illness cognitions: Illness Cognitions Questionnaire (ICQ)
Time Frame: pre and post treatment
pre and post treatment
marital satisfaction: Maudsley Marital Questionnaire (MMQ)
Time Frame: pre and post treatment
pre and post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Netherlands Alzheimer Foundation

Investigators

  • Principal Investigator: Jan Pieter Teunisse, PhD, Radboud university medical center
  • Principal Investigator: Floor Kraaimaat, Professor, Radboud university medical center
  • Principal Investigator: Marcel Olde Rikkert, Professor, Coordinator Alzheimer Centre UMC Nijmegen
  • Principal Investigator: Myrra Vernooy, PhD, Coordinator Alzheimer Centre UMC Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 1, 2006

First Submitted That Met QC Criteria

February 1, 2006

First Posted (Estimate)

February 2, 2006

Study Record Updates

Last Update Posted (Estimate)

May 21, 2008

Last Update Submitted That Met QC Criteria

May 20, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V-2002-018
  • CMO-nr: 2003/071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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