Cognitive Behavioural Therapy for Persons With Mild Cognitive Impairment or Dementia in the Early Stages
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of participants reporting decrease in depression scores
研究概览
简要总结
A total of 200 home dwelling participants, who fulfil the inclusion criteria, Alzheimer's disease, will be recruited from three hospitals in Norway.
The intervention is based on a standardized manual, and consists of 11 weekly one-hour sessions, which are organized into six thematic modules.
The content of each session is specified by a treatment manual, which additionally consists of worksheets, suggestions for homework in between sessions and letters to the caregivers (the German manual: Werheid & Thöne-Otto, 2010; the Norwegian manual: Ulstein, Gordner & Tonga, not published). The treatment will be conducted by experienced health staff (nurses, psychologist, doctors) with formal training in Cognitive Behavioural Therapy, and knowledge about Alzheimer's Disease. Furthermore, the health staff will be familiarised with the manual before study inception, participate in a two-day training seminar and will regularly be supervised.
The control condition will be offered treatment as usual at the participating the memory clinics.
The hypothesis is that the participants in the intervention group will report less depression and increased self efficacy as compared with the control group.
We conducted a pilot study with 10 patients, 5 in each group, from March to June 2013 to examine the feasibility of the study protocol and do want to include these patients in the study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of dementia (Alzheimers disease or mixed Alzheimer and vascular dementia) within the past twelve months, consistent with the ICD-
- •Mini Mental Examination score of twenty or above Cornell Depression Scale score of five or above A career who is willing to participate in the interventions, as this is part of the treatment programme. A carer is here defined as the main person responsible for the informal care for the patient and who has regular weekly contact with the patient.
排除标准
- •Severe somatic or psychiatric comorbid diagnoses, including alcohol and substance abuse, that would impair their cooperation in the intervention programme Dementia with Lewy bodies and frontotemporal dementia, as the intervention is considered to be too cognitively challenging for these patients Poor command of Norwegian Ongoing psychotherapy
结局指标
主要结局
Number of participants reporting decrease in depression scores
时间窗: Up to nine month
Depression, measured by the Montegomery and Åsberg Depression Rating Scale (MADRS) (Åsberg et al., 1978), the Hospital Anxiety and Depression Scale (HAD) (Zigmond \& Snaith, 1983) and the Cornell Scale for Depression in Dementia (Alexopoulos, Abrams, Young \& Shamoian, 1988). In addition MADRS will be used to measure depression in the carers.
次要结局
- Number of participants reporting increased Self-efficacy(Up to 9 month)
- Number of participants reporting increased Quality of Life(Up to 9 month)
- Number of participants reporting change in cognitive function(Up to 9 month)
- Number of participating caregivers reporting decreased burden of care(3 month and 9 month)