Internet-delivered Psychological Interventions for Pediatric Disorders of Gut-brain Interaction - a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Peds QL gastro
研究概览
简要总结
Many children and adolescents often experience long-lasting stomach pain. In many cases, this is due to disorders of gut-brain interaction (DGBI), such as irritable bowel syndrome (IBS), functional abdominal pain, and functional dyspepsia. These conditions are caused by disrupted communication between the brain and the gut. They are linked to significant suffering, reduced quality of life, and higher school absenteeism. Psychological treatments such as cognitive behavioral therapy (CBT) have shown good effect, but waiting times within healthcare are often long. Therefore, there is a need for more accessible and cost-effective treatment alternatives.
The goal of this clinical trial is to explore whether gut-directed hypnotherapy, already used successfully in the Netherlands, can be implemented as a new treatment option in Swedish healthcare. In addition, the study will compare gut-directed hypnotherapy with internet-based CBT (iCBT) to learn which digital treatment works best for children and adolescents with DGBI.
Participants will:
Be children or adolescents between 8 and 17 years old.
First take part in a 4-week online education program called the "gut-school," which explains the stomach, the brain, and how symptoms can be managed.
If symptoms remain after the gut-school, be randomly assigned to one of two digital treatments:
iCBT (internet-based cognitive behavioral therapy). 10 week long.
Gut-directed hypnotherapy, delivered as audio recordings to be used at home. 12 week long.
Answer online survey questions before, during, and after treatment so researchers can follow their progress.
These two treatments have never been directly compared. By comparing them, researchers hope to learn not only which treatment works best overall, but also which treatment is most suitable for different participants. The long-term aim is to make gut-directed hypnotherapy, already successful in the Netherlands, available as a treatment option in Sweden.
详细描述
Gut-directed hypnotherapy has shown promising results in several international studies for the treatment of disorders of gut-brain interaction (DGBI). The treatment builds on relaxation techniques, imagery, and sensory exercises focused on gastrointestinal symptoms. The goal is to improve both awareness of and control over gastrointestinal symptoms. Hypnotherapy is considered safe and has been shown to have very few side effects. International research, particularly from the Netherlands, demonstrates that hypnotherapy leads to better outcomes in both the short and the long term compared to conventional medical treatment. Importantly, home-based audio exercises have been shown to be just as effective as individual face-to-face hypnotherapy delivered by a therapist.
Background and preparation:The research group has already conducted a pilot study in Sweden to test the feasibility of gut-directed hypnotherapy for children with DGBI. In collaboration with Dutch experts, the treatment manual was translated into Swedish, culturally validated by child psychologists, and recorded in high-quality audio format. A secure study platform has been developed to deliver the treatments and collect outcomes, and comprehensive information material for families has been produced, including written texts, films, and audio.
The pilot study, initiated in 2023, showed promising results in the primary outcome measure, PedsQL Gastro, demonstrating improvements in gastrointestinal symptoms. In addition, the pilot provided valuable insights that have led to adjustments in treatment details in order to further optimize the intervention for children and families. These encouraging findings support the implementation of the planned randomized controlled trial and strengthen confidence in the treatment approach, which has now been further optimized based on pilot insights.
Aim: The aim of this randomized controlled trial (RCT) is twofold: first, to evaluate whether gut-directed hypnotherapy can be implemented as a digital treatment option within Swedish healthcare, and second, to compare its effectiveness with internet-based cognitive behavioral therapy (iCBT). These two evidence-based psychological treatments have never before been directly compared. The trial seeks to determine not only which treatment is most effective overall, but also which treatment may be best suited for different participants.
Study population:The RCT will recruit approximately 300 children and adolescents aged 8-17 years who meet diagnostic criteria for DGBI according to the Rome IV classification. Recruitment will take place at pediatric gastroenterology clinics and general pediatric units across Sweden, including both specialized gastroenterology centers and local child health clinics. Before enrollment, all families will talk with a study physician or study nurse to review inclusion and exclusion criteria, receive study information, and go through the principles of both treatment options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 years
- •Basic somatic work-up completed (CRP/ESR, TGA, complete blood count, fecal calprotectin)
- •Confirmed DGBI diagnosis: IBS, functional abdominal pain, or functional dyspepsia (according to Rome IV criteria)
- •Any constipation must be treated according to current clinical guidelines, with stable laxative dosing for at least one month prior to referral
- •In cases of celiac disease, the participant must have followed a gluten-free diet for at least six months and TGA values must have normalized
- •For participants with a neuropsychiatric diagnosis treated with medication, at least two months must have passed since the last dose adjustment
- •At least one parent and the child/adolescent must be fluent in Swedish and willing to participate in both the educational program and treatment (regardless of randomization outcome), complete homework assignments, and respond to questionnaires
排除标准
- •Other organic disease that better explains the gastrointestinal symptoms
- •At referral assessment, psychiatric symptoms or psychosocial problems - such as severe bullying, high school absenteeism, or difficult family circumstances - are judged to be more prominent than the gastrointestinal problems and require more extensive, multiprofessional care than what the study can offer
- •Participants who have already completed gut-directed hypnotherapy or CBT
结局指标
主要结局
Peds QL gastro
时间窗: Assessments will be collected at baseline, after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6-month follow-up
Description: Short questionnaire gastrointestinal symptom scale. Minimum value 0, maximum value 100, higher score means better outcome.
次要结局
- Pain frequency(Assessments will be collected at baseline, after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6- and 24- month follow-up.)
- Pain intensity(Assessments will be collected at baseline, after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6- and 24- month follow-up.)
- Stress(Assessments will be collected after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6-month follow-up)
- Gastrointestinal symtom -related anxiety(Assessments will be collected at baseline, after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6-month follow-up.)
- GI symptom specific anxiety(Assessments will be collected after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6-month follow-up)
- Quality of life(Assessments will be collected at baseline, after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6-month follow-up)
- Adequate relief(Assessments will be collected after the gut-school (before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6-month follow-up)
- Self efficacy(Assessments will be collected after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6-month follow-up)
研究者
Ola Olen
Professor
Karolinska Institutet