Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale, HAM-D
研究概览
简要总结
The teaching platform of the TCM daycare clinics for depression patients will provide a good clinical training environment for the trainees. They can learn how to take care of depression patients by the lectures and the clinical practice experiences in the daycare clinics. They can also learn a holistic approach, a patient-centered healthcare service. This teaching model will strengthen the clinical training of TCM and enhance the international competitiveness of TCM doctors.
详细描述
Major depressive disorder (MDD) is a serious psychiatric illness with a high lifetime prevalence rate and causes major clinical, social and economic burden to patients and their family. Despite that more than 40 antidepressants with various mechanisms are available on the market, half of patients fail to achieve remission with optimized medication treatment because of unsatisfactory efficacy, frequent intolerability and poor compliance of pharmacotherapies. However, Traditional Chinese medicine (TCM) is a safe and effective therapy which has many previous evidences to improve the treatment of depression. The aim of this project is to build up a TCM clinical daycare model for depression patients, and to establish a teaching platform for TCM trainees.
The TCM daycare model will be provided by a team organized by doctors, nurses, pharmacists, psychologist, nutritionist and case managers. This model will provide a comprehensive TCM care system to improve the clinical symptoms and quality of life of depression patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of depression according to DSM-IV (Diagnosis code: 296.21-296.30, 300.4)
- •Age 18-65 years, male or female
- •Evaluation of the 21-item Hamilton Rating Scale for Depression (HAMD) 8 points or more
- •Fully understand the entire research plan and sign the informed consent form (aged 18-20 years old must be jointly signed by a legal agent)
排除标准
- •Have a diagnosis of mental illness other than depression in the last or past 6 months, including unipolar major depression, including dyslexia, organic mental disorder, impulse control disorder, substance use disorder, bipolar mental disorder or substance abuse.
- •Medical history of patients diagnosed with borderline, antisocial personality disorder
- •Take anti-psychotic disorders and anti-epileptic drugs in the past six months.
- •Have or may become pregnant
- •A person with serious suicidal ideation or suicide attempt who must be hospitalized for close monitoring
结局指标
主要结局
Hamilton Depression Rating Scale, HAM-D
时间窗: Start of treatment (day 0) and end of treatment (week 8)
Each question of HAM-D is rated 3-5 points, eight questions are 0-2 points, nine questions are 0-4 points, and the total score is 0-52 points. Evaluate the emotional and physical and mental states observed in the case during the most recent week and interview.
Beck Depression Inventory(BDI)
时间窗: Start of treatment (day 0) and end of treatment (week 8)
Beck Depression Inventory assesses the degree of depression of 13-80 year olds, as a diagnosis and treatment reference
Pittsburgh Sleep Quality Inventory
时间窗: Start of treatment (day 0) and end of treatment (week 8)
It is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, and is also suitable for the evaluation of sleep quality in ordinary people.
WHOQOL-Taiwan
时间窗: Start of treatment (day 0) and end of treatment (week 8)
Four-dimension: Physiology + Independence; Psychology + Spirituality/Religion/Personal Belief;
次要结局
未报告次要终点