Internet-delivered Cognitive Behavior Therapy Compared to Stress Management in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Level of IBS symptoms
研究概览
简要总结
The study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks.
Approximately 200 patients will be included in the study and randomized to either condition.
The study hypothesis is that CBT will be superior to stress management on the main outcome measure, which is IBS symptom severity measured over 4 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IBS given by physician
- •At screening fulfilling Rome III-criteria for IBS
排除标准
- •Severe depression
- •Suicidal ideation
- •Presence of unexplained IBS alarm symptoms
结局指标
主要结局
Level of IBS symptoms
时间窗: During 4 consecutive weeks 6 months after treatment completion
The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.
次要结局
- Quality of life(Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion)
- Use of health care resources and societal production loss because of illness(Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion)
- Level of IBS-symptoms(Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion)
- Anxiety related to gastrointestinal symptoms(Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion)
- Level of daily stress(Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion)
- Subjective relief of IBS-symptoms(Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion)
研究者
Brjann Ljotsson
PhD
Karolinska Institutet