Cognitive-Behavioral Treatment for Mild Alzheimer's Patients and Their Caregivers (CBTAC)
2017年11月1日 更新者：Simon Forstmeier、University of Zurich
Cognitive-Behavioral Treatment for Patients With Mild Alzheimer's Dementia: A Randomized Controlled Trial
The purpose of this study is to determine whether a comprehensive cognitive-behavioral therapy-based, multi-component treatment programme is effective in the treatment of neuropsychiatric symptoms of patients with mild Alzheimer's dementia.
研究概览
地位
完全的
条件
详细说明
Mild Alzheimer's dementia (AD) cases are with 15 millions worldwide the largest fraction of all AD cases. Most patients are cared for by their family at home. Neuropsychiatric symptoms are very common in AD, even as early as in mild AD: About 90% of all mild AD cases experience neuropsychiatric symptoms, most frequently depression, anxiety, and irritability. These symptoms are associated with greater morbidity, reduced quality of life for the patient, increased burden and depression for the caregiver, higher costs of care, and nursing home placement. Thus, interventions aimed at treating these symptoms could have a tremendous effect on pa-tients, caregivers, and society.
This study is a randomized, controlled trial (RCT) evaluating a comprehensive CBT-based, multi-component treatment programme consisting of eight modules (diagnosis and goal-setting; psycho-education; engagement in pleasant activities; cognitive restructuring; life review; training caregiver in behavior management techniques; interventions for the caregiver; couples counseling) and 20 sessions.
This trial aims at significantly reducing depressive and other neuropsychiatric symptoms in the AD patients, and secondary in reducing burden and depressive symptoms of the caregivers. Patients with AD alone or mixed AD and vascular dementia that are in the mild stage and suffer under any neuropsychiatric symptom will be included. The patients and their caregiver will be randomized to either the CBT-based intervention or to the control condition that receives treatment as usual (TAU).
研究类型
介入性
注册 (实际的)
50
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Zurich、瑞士、8032
- Psychiatric University Hospital, Clinic for Geriatric Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 95年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients have to meet NINCDS-ADRDA criteria for probable or possible AD (McKhann et al., 1984). Mixed Alzheimer and Vascular dementia cases will also be included.
- Only AD cases with a mild dementia severity will be included, determined by the Clinical Dementia Rating (CDR) scale (i.e. scores of 0.5 or 1, Morris, 1993) and by the Mini Mental State Examination (MMSE) (i.e. scores of 20 or more, Folstein, Folstein, & McHugh, 1975).
- The patient must suffer under any non-cognitive symptom that motivates him to accept psy-chotherapeutic help.
- A caregiver must be available to take part in most of the therapy sessions.
Exclusion Criteria:
- concomitant alcohol or drug addiction and a history of a malignant disease, severe organ failure, metabolic or hematologic disorders, neurosurgery or neurological condition such as Parkinson's disease, epilepsy, postencephalitic and postconcussional syndrome
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cognitive Behavioral Therapy (CBT)
Comprehensive, CBT-based, multi-component treatment.
Comprehensive CBT intervention in addition to standard treatment
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It includes eight modules: diagnosis and goal setting; psychoeducation; engagement in pleasant activities; cognitive restructuring; live review; training caregiver in behavior man-agement techniques; interventions for the caregiver; and couples counselling.
It consists of 20 weekly sessions (plus appr.
5 single session with caregiver).
其他名称：
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有源比较器：Treatment as usual (TAU)
Standard Treatment (medical and psychosocial)
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Each patient/caregiver must receive at least three out of six interventions: (1) psychoeducation on dementia and treatment of dementia (oral and written); (2) appropriate medical treatment; (3) social counseling by specialized staff; (4) memory training in group setting; (5) self-help group for the patient; (6) self-help group for the caregiver.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change from baseline in Geriatric Depression Scale (GDS)
大体时间：Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change from baseline in Neuropsychiatric Inventory (NPI)
大体时间：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Change from baseline in Bayer-Activities of Daily Living (B-ADL)
大体时间：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Change from baseline in Stress Coping Inventory (SCI)
大体时间：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Change from baseline in Apathy Evaluation Scale (AES)
大体时间：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
大体时间：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Trait scale of the State Trait Anxiety Inventory (STAI)
大体时间：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Anger-in and anger-out scales of the State Trait Anger Expression Inventory (STAXI)
大体时间：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Short-Form Health Survey (SF-12)
大体时间：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Zarit Burden Interview (ZBI)
大体时间：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Stress Coping Inventory (SCI)
大体时间：Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Simon Forstmeier, Ph.D.、University of Zurich
- 学习椅：Andreas Maercker, M.D.,Ph.D.、University of Zurich
- 学习椅：Egemen Savaskan, M.D.、Psychiatric University Hospital, Zurich
- 学习椅：Tanja Roth, Ph.D.、Psychiatric University Hospital, Zurich
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Forstmeier S, Maercker A. Problems of aging. Psychotherapy in older age [German]. Göttingen, Germany: Hogrefe. 2008.
- Forstmeier S, Maercker A. Psychotherapie im Alter. Psychotherapeutenjournal 4: 340-352, 2007
- Forstmeier S, Maercker A, Savaskan E, Roth T. Cognitive behavioural treatment for mild Alzheimer's patients and their caregivers (CBTAC): study protocol for a randomized controlled trial. Trials. 2015 Nov 17;16:526. doi: 10.1186/s13063-015-1043-0.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年2月1日
初级完成 (实际的)
2017年9月1日
研究完成 (实际的)
2017年9月1日
研究注册日期
首次提交
2011年1月3日
首先提交符合 QC 标准的
2011年1月7日
首次发布 (估计)
2011年1月10日
研究记录更新
最后更新发布 (实际的)
2017年11月6日
上次提交的符合 QC 标准的更新
2017年11月1日
最后验证
2017年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.