Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome, According to a Non-inferiority Design. Three-armed Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 7
- 主要终点
- Abdominal pain response rate after 12 weeks of treatment
研究概览
简要总结
Psychological therapies are effective in reducing irritable bowel syndrome (IBS) symptom severity and increasing quality of life and are recommended for the management of IBS by guidelines. Evidence appears strongest for the efficacy of hypnotherapy as psychological treatment. However, therapist-led interventions are time consuming and relatively costly. Approaches based on e-health are cost saving and appear more attractive to patients as no visits to a therapist are necessary. Therefore, the investigators plan to conduct a multicentre randomised controlled trial to examine whether the effectiveness of online hypnotherapy is non-inferior compared to individual face-to-face hypnotherapy delivered by a therapist, according to current FDA guidelines. Online psychoeducation will be used as control condition. In addition, the investigators hypothesize that treatment with online hypnotherapy is a more cost-effective therapy than face-to-face hypnotherapy in IBS patients.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Abdominal pain response rate after 12 weeks of treatment
时间窗: 12 weeks
A responder is defined as a patient who experiences at least a 30 percent decrease in the weekly average of worst daily abdominal pain (measured daily, on an 11 point NRS) compared to baseline weekly average in at least 50 percent of the weeks in which the treatment in given.
次要结局
- Indirect costs(16 weeks and after 6 months and 1 year follow-up)
- General Quality of life (by EQ-5D)(16 weeks and after 6 months and 1 year follow-up)
- Use of over the counter medication and rescue medication(12 and 16 weeks)
- Response rates in relation to comorbid depression(16 weeks and after 6 months and 1 year follow-up)
- Improvement of symptom severity(16 weeks)
- Expectation(16 weeks)
- Response rates in relation to comorbid anxiety(16 weeks and after 6 months and 1 year follow-up)
- Degree of relief response rate after 12 weeks of treatment(12 weeks)
- IBS related Quality of life (by IBS-QoL)(16 weeks and after 6 months and 1 year follow-up)
- Number and severity of side effects(12 and 16 weeks)
- Direct costs(16 weeks and after 6 months and 1 year follow-up)