Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in gastrointestinal symptoms from baseline to 8 weeks, and from baseline to 6 months after treatment.
研究概览
简要总结
This pilot-study aims to evaluate the treatment effects and feasibility of an internet-delivered CBT-program for adolescents with functional gastrointestinal disorders.
详细描述
Functional gastrointestinal disorders (FGID), including irritable bowel syndrome (IBS), functional dyspepsia (FD) and functional abdominal pain (FAP), are common in adolescents and associated with impaired quality of life. In adults with IBS, internet-delivered CBT leads to reduced symptoms and increased quality of life, but studies in children are lacking. This pilot-study aim to evaluate the treatment effects and feasibility of an internet-delivered CBT-program for adolescents with FGID.
Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program lasted for 8 weeks and included weekly therapist support, consisting of online messages and telephone calls. Assessment points were baseline, post-treatment and 6 months follow-up.
Analysis: Effect sizes and within-group differences were calculated in an intent-to-treat analysis using Cohens' d and Student's t-test.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 13 and 17 years old.
- •a diagnosis of a functional gastrointestinal disorder by treating physician, e.g. IBS, FD or FAP.
- •adolescent and one parent should have easy access to the Internet, some computer experience and good Swedish language skills.
排除标准
- •concurrent serious medical conditions or gastrointestinal symptoms likely caused by an organic disorder.
- •psychiatric diagnosis more urgent to treat than the abdominal pain.
- •on-going psychological treatment.
- •absence from school more than 20%.
- •on-going maltreatment, violence or severe parental psychiatric illness in the family.
- •pronounced language and learning difficulties depending on whether the youth was expected to benefit from the treatment or not.
研究组 & 干预措施
Internet-delivered CBT
干预措施: Internet-delivered CBT (Behavioral)
结局指标
主要结局
Change in gastrointestinal symptoms from baseline to 8 weeks, and from baseline to 6 months after treatment.
时间窗: Baseline to 8 weeks, baseline to 8 months.
Measured with a self-report scale, GSRS-IBS, that have 13 items about weekly gastro-intestinal symptoms like bloating, hard stool, abdominal pain etc. It is a seven-point Likert scale, from 1 ("no trouble 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
- Change in pain reactivity from baseline to 8 weeks, and from baseline to 6 months after treatment.(Baseline to 8 weeks, baseline to 8 months.)
- Change in pain interference on activities from baseline to 8 weeks, and baseline to 6 months after treatment.(Baseline to 8 weeks, baseline to 8 months.)
- Change in function from baseline to 8 weeks and from baseline to 6 months after treatment.(Baseline to 8 weeks, baseline to 8 months.)
- Change in sensitivity to symptoms of anxiety from baseline to 8 weeks, and from baseline to 6 months after treatment.(Baseline to 8 weeks, baseline to 8 months.)
- Change in level of depression from baseline to 8 weeks and from baseline to 6 months after treatment.(Baseline, 8 weeks and 8 months.)
- Change in level of perceived stress from baseline to 8 weeks and from baseline to 6 months after treatment.(Baseline, 8 weeks and 8 months.)
研究者
Brjann Ljotsson
PhD
Karolinska Institutet