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临床试验/NCT00596284
NCT00596284已完成1 期

Cognitive Behavior Therapy for Anxiety in Dementia

Baylor College of Medicine4 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
34
试验地点
4
主要终点
Rating Anxiety in Dementia (RAID) and Neuropsychiatric Inventory (NPI)- Anxiety subscales

研究概览

简要总结

This study will evaluate the effectiveness of cognitive behavioral therapy in treating anxiety in older adults with dementia.

详细描述

Dementia is an illness that causes memory problems; changes in behavior; and difficulty with thinking, making decisions, and carrying out daily activities. Many people with dementia also have anxiety, and yet very little is known about effective treatment strategies for anxiety in this population. Cognitive behavioral therapy (CBT) is a type of psychotherapy that is commonly used to treat anxiety. CBT involves teaching patients skills to help them manage their anxiety, such as relaxation, changing their thoughts, and problem-solving. This study will evaluate the effectiveness of CBT in treating anxiety in older adults with dementia. In addition, the study will determine the effect of the treatment on patients' families and friends, and how families and friends may be able to help patients manage their anxiety. All study participants will name a family member or friend who will also participate in the study.

All participants in this study will answer a preliminary set of questions about anxiety and memory and will then complete a number of activities that involve learning and memory. These evaluations will take approximately 45 minutes. Participants who are selected to continue in the study will answer a second set of questions about mood, memory, concentration, and how they are doing in certain areas of life. These interview questions will take place during 2 sessions and will last a total of approximately 3 hours. Participants will then be randomly assigned to receive either enhanced usual care (EUC) or 8 to 10 sessions of CBT over a period of 10 to 12 weeks. Each CBT session will last about 1 hour and will include meeting with a study staff member to discuss anxiety and how to cope with it. Participants will also complete practice activities at home for about 20 minutes per day. EUC will consist of regular ongoing care from healthcare providers and phone assessments at 1-month and 2-month. Following the 6 month assessment, participants in EUC will be offered a Cognitive Behavior Workshop. Following in-person meetings, CBT participants will receive weekly phone calls for 3 months, followed by biweekly phone calls for the next 3 months. Some of the pretreatment questions will be asked again at 3 months and again 6 months after baseline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Alzheimer's disease that is in the mild or moderate range according to a score of 0.5 to 2.0 on the Clinical Dementia Rating (CDR) Scale
  • Significant anxiety as defined by a score of 4 on the Neuropsychiatric Inventory (NPI)
  • Agrees to permit participation of a collateral
  • English-speaking

排除标准

  • Suicidal intent
  • Current psychosis or bipolar disorder
  • History of substance abuse within 1 month prior to study entry

结局指标

主要结局

Rating Anxiety in Dementia (RAID) and Neuropsychiatric Inventory (NPI)- Anxiety subscales

时间窗: Measured at pre-treatment, post-treatment, and 3-month follow-up

次要结局

  • Geriatric Depression Scale (GDS)(Measured at pre-treatment, post-treatment, and 3-month follow-up)
  • Quality of Life in Alzheimer's Disease (QOL-AD)(Measured at pre-treatment, post-treatment, and 3-month follow-up)
  • Penn State Worry Questionnaire (PSWQ)(Measured at pre-treatment, post-treatment, and 3-month follow-up)
  • Geriatric Anxiety Inventory (GAI)(Measured at pre-treatment, post-treatment, and 3-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melinda Stanley

Professor

Baylor College of Medicine

研究点 (4)

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