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
- 1
- 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
研究组 & 干预措施
Attention control
Weekly support from therapist without CBT-interventions
干预措施: Therapist support (Behavioral)
Internet CBT
Internet-delivered cognitive behavioral therapy with therapist support
干预措施: Internet-delivered CBT (Behavioral)
结局指标
主要结局
Gastrointestinal symptoms
时间窗: One year after the treatment ended
Gastrointestinal Symptom rating scale (GSRS)
Gastrointestinal symptoms
时间窗: One week before the treatment starts
Gastrointestinal Symptom rating scale (GSRS)
Gastrointestinal symptoms
时间窗: 10 weeks after the treatment started
Gastrointestinal Symptom rating scale (GSRS)
Gastrointestinal symptoms
时间窗: 3 months 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)
- Quality of life(3 months after the treatment ended)
- Gastrointestinal symptom-specific anxiety(One week before the treatment starts)
- Health economic data(One week before the treatment starts)
- Health economic data(10 weeks after the treatment started)
- Health economic data(3 months after the treatment ended)
- Quality of life(One week before the treatment starts)
- Quality of life(10 weeks after the treatment started)
- Gastrointestinal symptom-specific anxiety(10 weeks after the treatment started)
- Gastrointestinal symptom-specific anxiety(3 months after the treatment ended)
- Depressive symptoms(One week before the treatment starts)
- Depressive symptoms(10 weeks after the treatment started)
- Depressive symptoms(3 months after the treatment ended)
- Functional impairments in work, social and family life(One week before the treatment starts)
- Functional impairments in work, social and family life(10 weeks after the treatment started)
- Functional impairments in work, social and family life(3 months after the treatment ended)