Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Gastrointestinal symptoms
研究概览
简要总结
The aim of this study is to investigate the efficacy of a 10 week Internet-delivered CBT treatment for patients diagnosed with IBS. The patients' work with the treatment and is supported through online contact with a therapist.
Approximately 86 patients will be included in the study and randomized to either condition.
All included patients are assessed one week before the treatment starts. After 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months follow-up after treatment.
Patients in treatment condition are hypothesized to experience significant reduction IBS symptoms, societal costs and quality of life compared to patients on waiting list.
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
Gastrointestinal symptoms
时间窗: One year after the treatment ended
Gastrointestinal Symptom rating scale (GSRS)
次要结局
- Health economic data(One year after the treatment ended)
- Quality of life(One year after the treatment ended)
- Gastrointestinal symptom-specific anxiety(One year after the treatment ended)
- Functional impairments in work, social and family life(One year after the treatment ended)
- Depressive symptoms(One year after the treatment ended)