NCT02113605已完成不适用
Exposure-Based CBT for Children With Functional Gastrointestinal Disorders - Development of a Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks
研究概览
简要总结
The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.
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
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 8-12 years
- •A diagnosis of a functional gastrointestinal disorder by a treating physician
排除标准
- •Concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder.
- •Psychiatric disorder more urgent to treat than the abdominal pain.
- •On-going psychological treatment.
- •Absence from school more than 40 %.
- •Ongoing maltreatment, violence or severe parental psychiatric illness.
- •Pronounced language or learning difficulties that hinder the child to benefit from the treatment.
结局指标
主要结局
Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks
时间窗: Baseline and 10 weeks
Change in Faces Pain Rating Scale (FACES) from baseline to 8 months.
时间窗: Baseline and 8 months.
次要结局
- Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks(Baseline and 10 weeks.)
- Change in Pain Reactivity Scale from baseline to 10 weeks.(Baseline and 10 weeks.)
- Change in Child Depression Inventory (CDI) from baseline to 10 weeks.(Baseline and 10 weeks.)
- Change in Pain Interference Index (PII) from baseline to 10 weeks.(Baseline and 10 weeks.)
- Change in Children´s Somatization Inventory (CSI 24) from baseline to 8 months(Baseline and 8 months.)
- Change in Spence Children Anxiety Scale (SCAS) from baseline to 10 weeks.(Baseline and 10 weeks.)
- Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 8 months.(Baseline and 8 months)
- Change in Pain Interference Index (PII) from baseline to 8 months.(Baseline and 8 months.)
- Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks(Baseline and 10 weeks.)
- Change in Functional Disability Index (FDI) from baseline to 10 weeks.(Baseline and 10 weeks.)
- Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 8 months.(Baseline and 8 months.)
- Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 8 months.(Baseline and 8 months.)
- Change in Functional Disability Index (FDI) from baseline to 8 months.(Baseline and 8 months.)
- Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 8 months.(Baseline and 8 months.)
- Change in Spence Children Anxiety Scale (SCAS) from baseline to 8 months.(Baseline and 8 months.)
- Change in Child Depression Inventory (CDI) from baseline to 8 months.(Baseline and 8 months.)
- Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks.(Baseline and 10 weeks.)
- Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 10 weeks.(Baseline and 10 weeks.)
- Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks.(Baseline and 10 weeks.)
- Change in Pain Reactivity Scale from baseline to 8 months.(Baseline and 8 months.)
研究者
Ola Olen
MD, PhD
Karolinska Institutet
研究点 (2)
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