Individualized Online Cognitive Behavioral Therapy for Children With Functional Abdominal Pain Disorders - the Child's Pain Regulation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Unpleasantness of pressure pain threshold on navel
研究概览
简要总结
Functional abdominal pain disorders (FAPDs) in children are common (14%) and abdominal pain has increased rapidly in children during the last ten years in Sweden. Many children with FAPDs have low quality of life, missed school days, and about 30-40% suffer from psychiatric comorbidity. FAPDs are often sustained into adulthood and a large Swedish cohort study showed that abdominal pain during childhood is an independent strong predictor anxiety and depression later in life. Internet-cognitive behavioral therapy (Internet-CBT) can improve FAPD symptoms, but a significant number of children does not respond to the treatment.
We will here determine the pain regulation in children with FAPDs, compared with healthy controls, and assess:
What aspects of the child's pain regulation is related to improvement for children with FAPDs engaging in Internet-CBT?
Does some aspects of the child's pain regulation change during treatment?
研究设计
- 研究类型
- 观察性
- 观察模型
- 病例对照
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Children 8-17 years with FAPDs: Have been offered treatment at BUP Internetbehandling for FAPDs.
- Children 8-17 years without FAPDs: Not affected by recurrent (every week) or persistant pain during the last year.
排除标准
- Contraindication for MR (metal implant or metal object in body, claustrophobia, pregnancy)
研究组 & 干预措施
FAPDs
Children 8-17 years with FAPDs
干预措施: Internet-delivered cognitive behavioral therapy (Other)
Controls
Children 8-17 years without FAPDs
结局指标
主要结局
Unpleasantness of pressure pain threshold on navel
时间窗: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Children rate their unpleasantness on a scale 0-10
Pressure pain threshold on navel
时间窗: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)
Algometer pressure (in kPa) for the pain threshold
次要结局
- fMRI during low pain compared with non-painful tactile stimulus(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Conditioned pain modulation(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Irritable bowel syndrome-behavioral responses questionnaire, child-adapted short version (BRQ-C)(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Unpleasantness of pressure pain threshold on thigh(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Sensory attenuation of pain(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Visceral sensitivity Index, child-adapted short version (VSI-C)(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Temporal summation(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Resting state fMRI(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Pediatric Quality of Life Inventory Gastrointestinal Symptom Scale (PedsQL Gastro)(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Faces Pain Rating Scale (FACES)(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
- Pressure pain threshold on thigh(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
研究者
研究点 (2)
标识符
- NCT 编号
- NCT05945251
- 其他研究编号
- 20223238
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (29天前)
- 研究完成日期
- (29天前)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否