Internet-delivered CBT for Functional Gastrointestinal Disorders (FGID) in Youth - A Single Case Experimental Design Study Embedded in The Danish FGID Treatment Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in gastrointestinal symptoms rated by parents assessed by PedsQL Gastro Symptom Scales
研究概览
简要总结
Functional gastrointestinal disorders (FGID) are common among children and adolescents. They affect quality of life, cause functional disability, school absence and high health care use. Despite this there is a lack in treatment options.
The aim of the current study, embedded in The Danish FGID Treatment Study, is to investigate the detailed course of efficacy of Danish versions of Swedish Internet based cognitive behavioural therapy (i-CBT) programs for children and adolescents with FGID in a Danish clinical context. This will be done using a single case design study. Along with this, the impact of parental illness worries will be investigated.
详细描述
A non-concurrent multi-variate baseline single-case experimental design study (SCED) will be conducted. It will consist of a baseline phase, a treatment phase and a follow up phase, including 6 children and 6 adolescents with their parents.
Participants will be randomly assigned to a baseline length with a duration between 5-15 days.
The design, using a multi-variate baseline, enables each participant to form their own control as outcomes during the baseline are compared with outcomes during treatment. This means that if treatment is effectual a change in outcome measures will show during the treatment period no matter when the treatment period was started.
Outcome will be assessed daily from baseline to end of treatment using electronic self-report questionnaire, with a last, one week long, daily assessment at 3-month follow-up.
The questionnaire is designed for this specific study and consist of 8 items (modified to a daily question) from validated questionnaires, the scale is changed to an 11 point scale from 0(not at all) to 10(all the time) Outcome are: abdominal symptoms (2 items from PedsQL Gastro 9 items questionnaire), symptom catastrophizing (2 items from Visceral Short sensitivity Index questionnaire), avoidance and control behavior (2 items from IBS Behavioural Response Questionnaire), and symptom acceptance(2 items from Chronic Pain Acceptance Questionnaire for Adolescents 8-items)
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
- •child age: 8-12 years, adolescents: 13 - 17 years
- •A primary diagnosis according to the ROME-IV criteria of one of the FGID sub-types: Irritable bowel syndrome (IBS) or functional abdominal pain not-otherwise-specified (FAP-NOS)
- •The diagnosis should be documented by their regular physician in the somatic setting, and recommended routine medical investigations should be evaluated as normal or without clinical significance (include growth; blood samples including TSH, total IgA, IgA tissue transglutaminase, complete blood count, C-reactive protein analysis, liver enzymes; and fecal calprotectin)
- •Stable dosage of FGID-related medication such as laxatives, anti-diarreal medication or pain-modulating psychopharmacological medication during the past month.
排除标准
- •Another disease that explains the symptoms;
- •Severe psychiatric or social problems (e.g., high level of suicidal ideation or ongoing abuse);
- •Ongoing psychological treatment;
- •Insufficient language or computer skills (patients and parents);
- •Severe family problems (e.g. child abuse, parental substance abuse or severe psychiatric illness, ongoing custody fight)
- •School absence of more than 40% over the past month.
结局指标
主要结局
Change in gastrointestinal symptoms rated by parents assessed by PedsQL Gastro Symptom Scales
时间窗: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
The parent-report questionnaire revised version of PedsQL Gastro Symptom Scales, with 9 items. Answered on a 5 point scale from 0 ("never") to 4 ("almost always)
Change in gastrointestinal symptoms assessed by PedsQL Gastro Symptom Scales
时间窗: At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up)
The self-report questionnaire revised version of PedsQL Gastro Symptom Scales, with 9 items. Answered on a 5 point scale from 0 ("never") to 4 ("almost always)
Single Case Design Outcome: Change in gastrointestinal symptoms measured via Daily Items as part of self-report SCED-Questionnaire
时间窗: Everyday during baseline (5-15 days before treatment start) and treatment (10 weeks) and during one week at 3 months follow-up
The SCED-Questionnaire consists of 8 daily items about Gastrointestinal symptoms, catastrophizing, Avoidance and control, acceptance. Answered on a 11 point scale from 0 ("not at all") to 10 ("all the time")
次要结局
- Changes in Overall symptom load measured by the self-report questionnaire Children somatization inventory , short (CSI)(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in Pain intensity rated by parents Measured by the parent-report rating scale, Faces pain scale, revised.(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Single Case Design Outcome: Change in catastrophizing, avoidance and control and acceptance via Daily Items, measured as part of self-report SCED-Questionnaire(Everyday during baseline (5-15 days before treatment start) and treatment (10 weeks) and during one week at 3 months follow-up)
- Changes in Quality of life assessed by the Pediatric Quality of Life Inventory(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in Depression symptoms measured by the self-report questionnaire Mood and Feelings Questionnaire short(At baseline, after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in Avoidance and control behaviour measured by the self-report questionnaire irritable bowel syndrome-behavioural response questionnaire(At baseline, mid-treatment, end-treatment and 3-months follow-up)
- Changes in Quality of life rated by parents assessed by Pediatric Quality of Life Inventory(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in General Anxiety symptoms measured by the self- report questionnaire Spence Children Anxiety Scale short(At baseline, after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in General Anxiety rated by parents, Measured by the parent- report questionnaire Spence Children Anxiety Scale short, parent report(At baseline, after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in Illness perception rated by parents, measured by the parent-report questionnaire Illness perception regarding child's symptoms Questionnaire(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in PARENTAL Illness Worry measured by the self-report The Health Anxiety by Proxy Scale (HAPYS) questionnaire(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in Pain intensity measured by the self-report rating scale, Faces pain scale, revised(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in Overall symptom load rated by parents measured by the parent-report questionnaire Children somatization inventory (parent report), short(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in Illness worry Measured by the self-report questionnaire Childhood Illness Attitude Scale(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in School absence / Work absence parent(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in Specific Gastrointestinal Anxiety, Measured by the self-report questionnaire Visceral Sensitivity Index - Short(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in Illness perception Measured by the self-report questionnaire Brief Illness perception Questionnaire(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in Acceptance, measured by the self-report questionnaire Chronic pain Acceptance Questionnaire -adolescents(At baseline, mid-treatment, end-treatment and 3-months follow-up)
- Changes in PARENTAL Emotional distress measured by the self-report questionnaire Symptom Check List (SCL-8)(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
- Changes in Adult Response to Child's Symptoms - PARENTS by the self-report questionnaire Adult Response to Children's Symptoms(At baseline, after 5 weeks of treatment (mid-treatment), after 10 weeks of treatment (end-treatment) and 3-months after treatment (follow-up))
研究者
Eva Skovslund Nielsen
PhD-Student, Medical doctor
Aarhus University Hospital