Internet-delivered Cognitive Behavior Therapy for Children With Pain-predominant Functional Gastrointestinal Disorders - an Open Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- PedsQL Gastro
研究概览
简要总结
This pilot-study aims to evaluate the effect size and feasibility of internet-delivered cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant functional gastrointestinal disorders (e.g. irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria). The main component investigated in this study is exposure for gastrointestinal symptoms and for feared stimuli and situations. Children will participate along with one of their parents in the treatment. The parents will also receive specific modules with information on how to support their child in the treatment.
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
- •Children between 8-12 years (until their 13th birthday) who have been diagnosed with any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional abdominal pain according to the Rome III criteria.
- •Any psychopharmacological medication should be stable since 1 month.
- •Parents and children need to master Swedish, have access to a computer with internet access, and be willing to participate in 10 weeks of treatment with homework.
排除标准
- •Simultaneous presence of serious somatic disease and / or if the child meets the criteria for other organic disease which better explains the symptoms.
- •Psychiatric or social problems that are considered serious and in need of a more intense treatment than ICBT leads to exclusion. Children with higher school absenteeism than 40% will not be included. Neither will children who have an ongoing psychological treatment be included,
研究组 & 干预措施
Internet-delivered CBT
Children and parents will receive 10 weekly modules of internet-delivered CBT (Cognitive Behavior Therapy). Parents will also receive 10 weekly specific modules for parents. Main components in the modules directed at children and parents are exposure for symptoms, feared stimuli and situations. The parents modules contain information on how they can support their children in the treatment and is based on social learning theory. Therapist support is provided through written messages within the secure platform. Therapists are trained CBT-psychologists.
干预措施: Internet-delivered CBT (Behavioral)
结局指标
主要结局
PedsQL Gastro
时间窗: Baseline to 10 weeks, baseline to 9 months
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.
次要结局
- Faces Pain Rating Scale. (FACES)(Weekly during treatment (treatment week 1-9))
- Pressure Activation Stress Scale (PAS)(Baseline to 10 weeks, baseline to 9 months)
- Visceral Sensitivity Index (IBS-VSI)(Baseline to 10 weeks, baseline to 9 months)
- Adverse Events (AE)(At 10 weeks)
- Pediatric Quality of Life Inventory (PedsQL)(Baseline to 10 weeks, baseline to 9 months)
- Patient Health Questionnaire (PHQ 9)(Baseline to 10 weeks, baseline to 9 months)
- Functional Disability Index (FDI)(Baseline to 10 weeks, baseline to 9 months)
- Insomnia Severity Index (ISI)(Baseline to 10 weeks, baseline to 9 months)
- Spence Children Anxiety Scale - short version (SCAS)(Baseline to 10 weeks, baseline to 9 months)
- Subjective Assessment Questionnaire (SAQ)(At 10 weeks)
- The Pain App(Baseline to 10 weeks, baseline to 9 months)
- Children´s Somatization Inventory (CSI 24)(Baseline to 10 weeks, baseline to 9 months)
- Pain Response Inventory (PRI) - subscale Coping(Baseline to 10 weeks, baseline to 9 months)
- PedsQL Gastro(Weekly during treatment (treatment week 1-9))
- ROME-III Questionnaire(Baseline to 10 weeks, baseline to 9 months)
- IBS-behavioral responses questionnaire (IBS-BRQ)(Weekly during treatment (treatment week 1-9))
- Child Depression Inventory - short version (CDI-S)(Baseline to 10 weeks, baseline to 9 months)
- Client satisfactory questionnaire (CSQ)(At 10 weeks)
- Generalized Anxiety Disorder Screener (GAD-7)(Baseline to 10 weeks, baseline to 9 months)
- Adult Responses to Children's Symptoms (ARCS)(Baseline to 10 weeks, baseline to 9 months)
- Parental Behavior in Response to Children's Functional Gastrointestinal Disorders(Weekly during treatment (treatment week 1-9))
- Faces Pain Rating Scale. (FACES)(Baseline to 10 weeks, baseline to 9 months)
- IBS-behavioral responses questionnaire (IBS-BRQ)(Baseline to 10 weeks, baseline to 9 months)
- Parental Behavior in Response to Children's Functional Gastrointestinal Disorders(Baseline to 10 weeks, baseline to 9 months)