Effects of a Mindfulness Therapy Intervention for Individuals With Inflammatory Bowel Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quality of life measured with the IBDQ-32 (Inflammatory Bowel Disease Questionnaire)
研究概览
简要总结
Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-asusual control group in patients with bowel disease. Design: randomized controlled trial. Setting: Outpatient setting. Population: patients who attended bimonthly check up.
详细描述
Background: Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition with a relapsing disease course. Managing the relapsing nature of the disease causes daily stress for IBD patients. Mindfulness-based Cognitive Therapy (MBCT) is an evidence-based psychological program designed to help manage depressive and stress symptoms.
Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-as usual control group in patients with bowel disease.
Outcome measures: quality of life, inflammatory and stress markers. Design: randomized controlled trial. Setting: Outpatient setting. Population: patients who attended bimonthly check up.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with bowel disease diagnostic
- •patients with non active disease symptoms in the last 3 month
- •patients with access to internet and basic informatic knowledge
排除标准
- •active disease symptoms
- •planned surgery
- •cognitive impairment
- •previous experience with mindfulness
研究组 & 干预措施
Mindfulness group
Mindfulness intervention (12 months). Mindfulness based Cognitive Therapy is an evidence-based psychological program designed to help manage depressive and stress symptoms.
干预措施: Mindfulness (Behavioral)
Control Group
Treatment-as-usual control
结局指标
主要结局
Quality of life measured with the IBDQ-32 (Inflammatory Bowel Disease Questionnaire)
时间窗: Change from Baseline IBDQ-32 score at 12 months
次要结局
- inflammation stress markers (reactive Protein C and faecal calprotectin)(Change from Baseline inflammation stress markers at 12 months)
研究者
Jose Miguel Soria Lopez
PhD, Professor
Cardenal Herrera University