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临床试验/NCT00285753
NCT00285753已完成2 期

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

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2003年11月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
110
试验地点
2
主要终点
caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

结局指标

主要结局

caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP)

时间窗: pre- and post intervention

quality of life: RAND, GDS

时间窗: pre and post treatment

次要结局

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

研究者

申办方类型
Other

研究点 (2)

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