Clinical Effectiveness of Exposure Based Cognitive Behavioral Group Therapy for IBS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 主要终点
- Gastro-Intestinal Symptom Rating Scale for IBS Gastrointestinal Symptom Rating Scale - IBS version
研究概览
简要总结
The aim of the study is to evaluate the effects of a specific Cognitive Behavioral treatment protocol for patients with IBS used in routine care at a gastroenterology unit in Stockholm. The research question is whether the treatment has the same effects in routine care as it has had in efficacy studies.
The treatment is given by licenced psychologists (with CBT training) face-to-face in groups of 4-7 participants and lasts for ten sessions (ten weeks, normally).
详细描述
IBS is a debilitating condition that affects approximately one out of eleven persons world wide. It is often called a functional disorder, a term used to characterize painful conditions, whose biological mechanisms are not fully understood.
Diagnosis is made based on symptoms and exclusion of other conditions rather than specific tests or biological markers.
Treatment usually starts with diet counselling and a change of eating habits. If symptoms persist, a physician can prescribe medication of different types. But for some patients neither change of diet, nor medication is sufficient. Some of these patients may benefit from psychological treatment. There are a few different psychological treatments that have been proven efficacious in clinical trials. Most researched is Cognitive Behavior Therapy (CBT).
Our study is a clinical effectiveness trial without a control group. The data comes from a gastroenterology clinic in Stockholm and is collected as part of the work with continous improvement at the clinic.
Patients with diagnosed IBS are offered group treatment with a specific CBT protocol developed by our research group at Karolinska Institutet. The treatment comprises 6 different modules and stretches over ten sessions. The modules are: 1. Information regarding the treatment, IBS and mindfulness. 2 Hypervigilance and anxiety. 3. Behaviors and thoughts. 4. Behavior change part one - toilet habits including exposure to feared situations. 5. Behavior change part two - exposure to symptoms and avoidance/control behaviors. 6. Summary and relapse prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with IBS
排除标准
- •Severe psychiatric condition (for example severe depression, self injuring, psychosis, PTSD)
- •Unable or unwilling to participate in group therapy
结局指标
主要结局
Gastro-Intestinal Symptom Rating Scale for IBS Gastrointestinal Symptom Rating Scale - IBS version
时间窗: Baseline to 10 veeks
Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, and from baseline to 9 months for analysis of effect.The GSRS-IBS have 13 items about weekly gastrointestinal symptoms like bloating, hard stool, abdominal pain etc. It is a seven-point Likert scale from 1 (no discomfort at all) to 7 (very severe discomfort). The GSRS-IBS has excellent psychometric properties with internal consistency between α = .74 (for abdominal pain) to α = .85 (for satiety).
次要结局
- The Montgomery-Åsberg Depression Rating Scale (MADRS-S)(Baseline to 10 veeks)
- Quality of Life in persons with Irritable Bowel Syndrome (QOL-IBS)(Baseline to 10 veeks)
- Visceral Sensitivity Index (VSI)(Baseline to 10 veeks)
研究者
Perjohan Lindfors
Principal investigator
Karolinska Institutet