Support Groups for Patients With Mild Cognitive Impairment and Their Partners

Mild Cognitive Impairment Clinical Trial

Official title:

Development and Evaluation of Support Groups for Patients With Mild Cognitive Impairment and Their Partners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285753
• Other study ID #: V-2002-018
• Secondary ID: CMO-nr: 2003/071
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2006
• Last updated: May 20, 2008
• Start date: November 2003
• Est. completion date: October 2007

Study information

• Verified date: May 2008
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Behavioral:
• support groups
cognitive behavioral intervention with psychoeducation

Locations

Country	Name	City	State
Netherlands	Rijnstate Ziekenhuis	Arnhem	Gelderland
Netherlands	UMC Sint Radboud	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Netherlands Alzheimer Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life: RAND, GDS		pre and post treatment	No
Primary	caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP)		pre- and post intervention	No
Secondary	Illness cognitions: Illness Cognitions Questionnaire (ICQ)		pre and post treatment	No
Secondary	marital satisfaction: Maudsley Marital Questionnaire (MMQ)		pre and post treatment	No