Support Groups for Patients With Mild Cognitive Impairment and Their Partners

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00285753

Collaborator

Netherlands Alzheimer Foundation (Other)

110

Enrollment

Locations

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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:

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

Study Type:

Interventional

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 :

Nov 1, 2003

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

quality of life: RAND, GDS [pre and post treatment]
caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP) [pre- and post intervention]

Secondary Outcome Measures

Illness cognitions: Illness Cognitions Questionnaire (ICQ) [pre and post treatment]
marital satisfaction: Maudsley Marital Questionnaire (MMQ) [pre and post treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rijnstate Ziekenhuis	Arnhem	Gelderland	Netherlands
2	UMC Sint Radboud	Nijmegen	Gelderland	Netherlands	6500 HB

Sponsors and Collaborators

Radboud University Medical Center
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