Psychological Stress and Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Cortisol y psychological stress levels
研究概览
简要总结
150 patients of legal age will participate in this project, diagnosed with systemic sclerosis.
Patients will be randomly assigned, as will be detailed later, to one of the following three groups:
Therapy Group (GT): This group will be made up of 50 patients who will receive cognitive behavioral therapy of coping with stress (online modality) in groups of 10-12 people during twelve sessions Consecutive weekly courses of 1.5 to 2 hours duration taught by psychology professionals. of this mode 4 subgroups will be made. Psychological Support Group (AP): This group will be made up of 50 patients who will receive psychoeducation about stress and its consequences and the specific stress suffered by people with a autoimmune disease such as scleroderma. It will have a duration of twelve weekly sessions.
Consecutive sessions of 1.5 to 2 hours in length taught by professional psychologists. In this way they will 4 subgroups. Usual Care Group (CG): This group will be made up of 50 patients who will follow their usual care. Later, once the study is over, they will be offered to participate in coping with stress to the person who is interested.
详细描述
150 elderly patients diagnosed with systemic sclerosis in any of its variants, both diffuse, limited or sine scleroderma.
The inclusion criteria are: diagnosis made by a medical specialist, good command of the Spanish language (oral and written comprehension) and have an internet connection. As exclusion criteria they must not suffer no psychiatric illness. Patients will be randomly assigned into each of the three groups.
Informed consent. Patients must be informed in writing of the objectives of the project and of the work protocol in which they are going to be included. Once read and understood, They will sign the consent. The research staff is obliged to save said consents.
Confidentiality and data protection commitment. Ethical principles will be followed and deontological related to psychological research collected in the main codes currently nationally or internationally: The Code of the Official College of Psychologists (1987), the Meta- Code of the European Federation of Psychological Associations (1995), and The Ethical Principles and Code of Conduct of Psychologists of the American Psychological Association (2002).
Instruments:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis made by a specialist doctor, good command of the Spanish language (oral and written comprehension) and have an internet connection.
排除标准
- •No psychiatric illness.
结局指标
主要结局
Cortisol y psychological stress levels
时间窗: 3 months
Decreased cortisol and psychological stress after therapy
次要结局
- Quality of life and psychological status(3 months)
研究者
Eva Montero Lopez
Principal investigator. PhD in Psychology. Clinic Psychologist
Asociación Española de Esclerodermia