Internet-delivered Exposure-based Cognitive Behavior Therapy for Pain-predominant Functional Gastrointestinal Disorders in Children and Adolescents: an Implementation Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
研究概览
简要总结
This open trial aims to evaluate feasibility and preliminary effectiveness of an internet-delivered CBT-program for children and adolescents with functional gastrointestinal disorders when implemented in regular care.
详细描述
Pain predominant functional gastrointestinal disorders (P-FGIDs) are common in children and adolescents and associated with impaired quality of life. Our research group have previously in a series of efficacy-studies shown that internet-delivered exposure-based CBT leads to reduced symptoms and increased quality of life in children and adolescents with P-FGIDs. There is therefore reason to investigate how the treatment should be disseminated in regular care. This open trial aim to evaluate feasibility and preliminary treatment effects in regular care of the internet-delivered CBT-program for children and adolescents with P-FGIDs.
Method: Open trial with a pretest-posttest-design and no control group. The internet-delivered CBT-program is 10 week long and include weekly therapist support, consisting of online messages and telephone calls. Assessment points are baseline, weekly during treatment, post-treatment and follow-up at 3 months and 6 months after treatment completion.
Analysis: Effect sizes and within-group differences will be 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
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8-17 at date of inclusion.
- •Fulfilling Rome IV-criteria for irritable bowel syndrome, functional dyspepsia or functional abdominal pain with a written statement from patient's physician confirming a diagnosis.
- •Stable psychotropic medication for at least 1 month.
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 structured psychological treatment.
- •absence from school exceeding an average of 2 days a week the last month is a cause for exclusion since high school 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.
研究组 & 干预措施
Internet-delivered CBT
Exposure-based internet-delivered CBT with ten weekly modules distributed over the internet during ten weeks, and weekly therapist support over the internet.
干预措施: Exposure-based internet-delivered CBT (Behavioral)
结局指标
主要结局
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
时间窗: Baseline to 10 weeks.
Change in global gastrointestinal symptoms from baseline to 10 weeks.
次要结局
- Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).(Baseline to 8 months.)
- Gastrointestinal symptoms module (PedsQL Gastro)(Baseline to 8 months.)
- Fear for symptoms (Visceral sensitivity index)(Baseline to 8 months.)
- Quality of life (PedsQL)(Baseline to 8 months.)
- Avoidant behavior (IBS-BRQ)(Baseline to 8 months.)
- Pain intensity (Faces Pain rating scale)(Baseline to 8 months.)
研究者
Marianne Bonnert
PhD
Karolinska Institutet