Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 311
- 主要终点
- Gastrointestinal symptom rating scale
研究概览
简要总结
Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral. They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. Both programs include mindfulness training, education about how excessive avoidant and control behaviors maintain IBS symptoms, and changing of these behaviors to live a richer life. One of the programs also includes instructions on how to perform systematic exposure. The hypothesis of the study is while both groups will show improvement in terms of IBS symptom severity and quality of life, the addition of systematic exposure will lead to more improvement in symptoms.
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
- •Fluency in Swedish
- •IBS-diagnosis established by physician
- •Fulfillment of Rome III criteria for IBS
排除标准
- •Diarrhea predominance with no colonoscopy performed
- •Blood in stool without benign medical explanation
- •Rapid weight loss without benign medical explanation
- •Ongoing alcohol or drug abuse
- •Suicidal ideation
研究组 & 干预措施
CBT without exposure
干预措施: Cognitive Behavioral Therapy without exposure (Behavioral)
CBT with exposure
干预措施: Cognitive Behavioral Therapy with exposure (Behavioral)
结局指标
主要结局
Gastrointestinal symptom rating scale
时间窗: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
Gastrointestinal symptom rating scale
时间窗: 1 week before randomization
Gastrointestinal symptom rating scale
时间窗: 10 weeks after randomization (i.e. after conclusion of treatment)
次要结局
- Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)(36 weeks after randomization (i.e. 6 months after conclusion of treatment))
- Visceral Sensitivity Index (VSI)(36 weeks after randomization (i.e. 6 months after conclusion of treatment))
- Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)(1 week before randomization)
- Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)(10 weeks after randomization (i.e. after conclusion of treatment))
- Visceral Sensitivity Index (VSI)(1 week before randomization)
- Visceral Sensitivity Index (VSI)(10 weeks after randomization (i.e. after conclusion of treatment))
研究者
Brjann Ljotsson
Principal Investigator
Karolinska Institutet