Cognitive Behavioral Therapy for African Americans With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Number of participants attending CBT sessions (participants retention)
研究概览
简要总结
The aim of the study is to test the feasibility and acceptability of a six-month cognitive-behavioral therapy (CBT) program (group based and phone-based) compared with usual care, and to determine if the intervention can improve cognitive performance and reduce chronic stress in a randomized trial including 30 African American patients with Mild Cognitive Impairment (MCI). The CBT program among African Americans with MCI will provide preliminary evidence about the efficacy and the optimal intensity of the intervention needed for patients at risk of Alzheimer's disease (AD).
详细描述
Mild Cognitive Impairment (MCI) can involve problems with memory, language, thinking and judgment that are greater than normal age-related changes and it maybe a precursor for Alzheimer's disease. African Americans have a higher risk of developing MCI compared with Whites. Unfortunately, prevention and management of MCI has been understudied among African-Americans. Chronic stress (such as perceived discrimination, daily environmental stress) in African Americans can affect cognition and also plays a role in worsening of unhealthy behaviors such as smoking, improper diet and physical inactivity. Cognitive-behavioral therapy (CBT) is a collaborative psychological approach that addresses the interaction between people's thoughts, feelings and behavior. Existing evidence suggests that CBT can be an effective strategy for dementia patients with co-morbid anxiety. However, none of these studies have specifically evaluated African Americans with MCI. The aim of the study is to test the feasibility and acceptability of a six-month CBT program (group based and phone-based) compared with usual care, and to determine if the intervention can improve cognitive performance and reduce chronic stress in a randomized trial including 30 African American patients with MCI. The CBT program among African Americans with MCI will provide preliminary evidence about the efficacy and the optimal intensity of the intervention needed for patients at risk of Alzheimer's disease.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 50 years or older
- •Race: African American
- •Fluency in English
- •Mild Cognitive Impairment (MCI) - defined as subjective memory complaints with a Montreal Cognitive Assessment (MoCA) 18- 26
排除标准
- •Dementia diagnosis or reversible causes of dementia (e.g. if the patient has hypothyroidism or low vitamin B12 that is contributing to the subject's cognitive impairment)
- •Active medical or psychiatric diseases that in the judgment of the investigator would affect the safety of the subject or scientific integrity of the study (e.g. actively manic patient)
- •Uncontrolled medical conditions (such as congestive heart failure) reflected by poor exercise tolerance and shortness of breath
- •Any physical ailment (such as stroke with residual impairment) that is a barrier to perform study procedures and attend sessions.
- •Those who are unable to demonstrate that they understood the details of the study (i.e. lack of decisional- capacity to consent) or linguistic limitations will be excluded;
- •Pregnant women
- •Prisoners
- •Adults unable to consent
结局指标
主要结局
Number of participants attending CBT sessions (participants retention)
时间窗: 3 and 6 months follow up
Participants retention will be estimated by number of participants attending CBT sessions.
Percentage of patients enrolled as per target (feasibility)
时间窗: Baseline
Feasibility of the six-month cognitive-behavioral therapy (CBT) program will be estimated by percentage of patients enrolled as per target.
次要结局
- Change in attitudes of patients regarding a CBT intervention for Mild Cognitive Impairment (MCI)(Baseline, 3 and 6 months follow up)
- Change in the Center for Epidemiological Studies-Depression (CESD-R) score(Baseline, 3 and 6 months follow up)
- Change in Perceived Stress Scale (PSS) score(Baseline, 3 and 6 months follow up)
- Change in the quality of life scale (36-Item Short-Form Health Survey (SF-36)) score(Baseline, 3 and 6 months follow up)
研究者
Ambar Kulshreshtha
Asstant Professor
Emory University
