Mindfulness Based Health Care (MBHC) Program for Caregivers in the Neuropsychiatric Disorders in Alzheimer Patients and Anxiety and Depression in Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in Anxiety and depression symptoms in Caregivers of Alzheimer patients measured with Hospital Anxiety and Depression scale
研究概览
简要总结
Mindfulness Based Health Care (MBHC) includes meditation techniques to help caregivers of Alzheimer patients to be made more aware of their experience in the present moment. Half of the caregivers will learn the practice of mindfulness meditation once a week through 8 classes, and the other half will not receive any therapy. The primary purpose of this study is to explore the effects of this mindfulness program for caregivers on the neuropsychiatric symptoms in Alzheimer patients, as well as on anxiety and depression symptoms in their caregivers. Secondarily, to examine the effect of this program on cognitive function, daily activity living and quality of life in Alzheimer patients, as well as on the burden of caregiving, quality of life, psychological well-being, occupational balance, executive function and self-compassion in their caregivers.
详细描述
Alzheimer's disease is a progressive brain disorder that involves the loss of the ability to live independently, functional capacity and safety. Thus, patients often suffer neuropsychiatric disorders and need help from another person to live every day. Due to the burden of caregiving, the main caregivers can have anxiety and depression symptoms. With this scenario, we will conduct this randomized controlled trial aimed to evaluate the effect of mindfulness program for caregiver's vs control group on: 1) neuropsychiatric disorders, cognitive function, daily activity living and quality of life in Alzheimer patients; 2) anxiety and depression symptoms, burden of caregiving, quality of life, psychological well-being, occupational balance, executive function and self-compassion in their caregivers.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Patient or caregivers with central nervous system disease with a neurological alteration (acquired brain damage, epilepsy, traumatic brain injury, multiple sclerosis and other movement disorders).
- •Patient or caregivers with current or past history of alcohol or drug abuse
- •Patient or caregivers with visual or hearing impairment
- •Patient or caregivers with serious psychiatric illness (depression, psychosis, schizophrenia)
结局指标
主要结局
Changes in Anxiety and depression symptoms in Caregivers of Alzheimer patients measured with Hospital Anxiety and Depression scale
时间窗: baseline, 8 weeks, 3 months after the 8 weeks
The Hospital Anxiety and Depression includes 14 items assessing anxiety (7-item) and depression (7-item), which are rated on a 4-point Likert-type (from 0 to 3). The scores in each subscale are computed by summing the corresponding items, with maximum scores of 21 for each subscale. A score of 0-7 is considered as normal, 8-10 as a borderline case, and 11-21 as a case (anxiety or depression)
Changes in Neuropsychiatric disorders of Alzheimer patients measured with Neuropsychiatric inventory
时间窗: baseline, 8 weeks, 3 months after the 8 weeks
Neuropsychiatric inventory includes 12 neuropsychiatric symptom domains: delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating disturbances. Neuropsychiatric manifestations within a domain are collectively rated by the caregiver in terms of both frequency (1 to 4) and severity (1 to 3), yielding a composite symptom domain score (frequency×severity). Frequency and severity rating scales have defined anchor points to enhance the reliability of caregiver responses. Caregiver distress is rated for each positive neuropsychiatric symptom domain on a scale anchored by scores of 0 (not distressing at all) and 5 (extremely distressing).
次要结局
- Changes in Functional Capacity of Alzheimer patients with Disability Assessment for Dementia(baseline, 8 weeks, 3 months after the 8 weeks)
- Changes in Quality of Life of Alzheimer patients with Quality of Life in Alzheimer's Disease scale(baseline, 8 weeks, 3 months after the 8 weeks)
- Changes in Cognitive Function of Alzheimer patients with Mini Mental State Examination(baseline, 8 weeks, 3 months after the 8 weeks)
- Changes in Executive Function of Alzheimer patients with Frontal Assessment Battery(baseline, 8 weeks, 3 months after the 8 weeks)
- Change in Caregiver Burden of Caregivers of Alzheimer patients measured with Zarit Burden Interview(baseline, 8 weeks, 3 months after the 8 weeks)
- Change in Quality of Life of Caregivers of Alzheimer patients measured with Study Questionnaire Short Form 36 Health Survey(baseline, 8 weeks, 3 months after the 8 weeks)
- Change in self-compassion of Caregivers of Alzheimer patients measured with Self-Compassion Scale(baseline, 8 weeks, 3 months after the 8 weeks)
- Change in Occupational Balance of Caregivers of Alzheimer patients measured with Occupational Balance Questionnaire.(baseline, 8 weeks, 3 months after the 8 weeks)
- Change in Executive Function of Caregivers of Alzheimer patients measured with Frontal Assessment Battery(baseline, 8 weeks, 3 months after the 8 weeks)
- Change in well-being of Caregivers of Alzheimer patients measured with Ryff's Well-being Scale(baseline, 8 weeks, 3 months after the 8 weeks)
研究者
ALICIA SANCHEZ PEREZ
Principal Investigator. Director of the Master's Degree in Occupational Therapy in Neurology
Universidad Miguel Hernandez de Elche