Effect of the Stress and Personality Profiles in the Development, Evolution and Treatment of Inflammatory Bowel Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Change in IBD activity at short and long-term
研究概览
简要总结
Main aim is to evaluate the role of stress in the evolution of inflammatory bowel disease (IBD) and the quality of life of these patients. A second aim is to establish the existence of any psicopathological profile in these patients. We designed a prospective experimental study were patients are randomized to receive or not a cognitive-behavior program. Patients will be evaluated at 3 and 12 months after the program and study variables will be measured: stress level, coping strategies, quality of life, activity of disease and biological variables related to IBD.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years
- •Informed consent
- •Crohn's disease or ulcerative colitis diagnosis
- •Active disease in the last 18 months
排除标准
- •Severe mental disease
- •Other severe concomitant disease
研究组 & 干预措施
Psychological intervention
Cognitive-behavior interventional program
干预措施: Cognitive-behavior interventional program (Behavioral)
Control
No intervention
结局指标
主要结局
Change in IBD activity at short and long-term
时间窗: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Number of clinical episodes of activity of IBD
次要结局
- Change in quality of life at short and long-term(Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months)
- Change in anxiety and depression at short and long-term(Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months)
- Change in stress scales at short and long-term(Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months)