Internet-delivered CBT for Irritable Bowel Syndrome in Adolescents - a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).
研究概览
简要总结
This randomized controlled trial aims to evaluate the treatment effects of an internet-delivered CBT-program for adolescents with irritable bowel syndrome.
详细描述
Irritable bowel syndrome (IBS) is prevalent and associated with low quality of life in adolescents. Medical or dietary treatments lack evident efficiency, while psychosocial interventions, i.e. cognitive behavior therapy (CBT)has shown promising effects in face-to-face treatments. Therapists trained to deliver CBT for IBS are scarce, leading to a situation where very few adolescents with IBS receive the only evidence-based intervention. Exposure-based internet-delivered CBT (ICBT) for adults with IBS has shown strong stable effects and cost-efficency. Our aim is to develop a treatment that enhances the availability to evidence-based treatment for children and adolescents with IBS. Such a treatment could swiftly be implemented in regular health care for this large population. The main purpose of this study is to compare the effectiveness of exposure-based ICBT to treatment as usual (wait-list) for adolescents with IBS.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13-17 at inclusion date.
- •fulfilling Rome III-criteria for IBS with a written statement from patient's physician confirming a diagnosis of IBS and negative required tests (Blood samples: C-reactive protein or erythrocyte sedimentation rate, Blood count and IgA-Transglutaminase. Stool: f-Calprotectin).
排除标准
- •concurrent serious medical conditions.
- •a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain.
- •on-going psychological treatment.
- •absence from school exceeding an average of 2 days a week is a cause for exclusion since high absence demands more intensive interventions than can be offered in ICBT.
- •on-going abuse or severe parental psychiatric illness in the family.
- •since treatment format assumes normal reading and writing skills, pronounced language skill deficits and learning difficulties lead to exclusion from the study.
- •lack of regular internet-access.
结局指标
主要结局
Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).
时间窗: Baseline to 27 months.
Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 27 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
- Pain reactivity Scale (PRS)(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- Percieved Stress scale (PSS 10)(Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- Visceral sensitivity Index (IBS-VSI)(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- Pediatric Quality of Life Inventory (PedsQL) Generic Core scales age 13-18(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- Children´s Somatization Inventory (CSI-24)(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- TIC-P Parent report(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- Faces pain scale - R(Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- IBS-behavioral responses questionnaire (IBS-BRQ).(Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- Functional disability index (FDI)(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- Spence Children's Anxiety Scale (SCAS-C)(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- TiC-P Adolescents revised version(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- Pain interference index (PII)(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS).(Weekly during treatment (treatment week 1-9).)
- Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptom Scale(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- Generalized Anxiety Disorder Screener (GAD-7)(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- Patient Health Questionnaire (PHQ 9)(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
- ARCS(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months.)
研究者
Brjann Ljotsson
PhD
Karolinska Institutet