Skovslund Nielsen Eva, Kallesøe Karen, Bennedsen Gehrt Tine, Bjerre-Nielsen Ellen, Lalouni Maria, Frostholm Lisbeth, Bonnert Marianne, Rask Charlotte Ulrikka
Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Aarhus N, Denmark.
Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark.
JMIR Res Protoc. 2025 Jan 7;14:e58563. doi: 10.2196/58563.
Functional abdominal pain disorders (FAPDs) are common in young people and are characterized by persistent or recurrent abdominal symptoms without apparent structural or biochemical abnormalities. FAPDs are associated with diminished quality of life, school absence, increased health care use, and comorbid anxiety and depression. Exposure-based internet-delivered cognitive behavioral therapy (ICBT) has demonstrated efficacy in alleviating abdominal symptoms and improving quality of life. However, a deeper understanding of effect mechanisms and identification of possible additional treatment targets could refine treatment.
This protocol paper aims to describe a study focusing on children and adolescents undergoing ICBT for FAPDs, aiming to further investigate the underlying mechanisms of effect.
Children (8-12 years), adolescents (13-17 years) with FAPDs, and their respective parents will be included for 10 weeks for ICBT. First, detailed trajectories of effect are examined through a randomized single-case design study involving 6 children and 6 adolescents (substudy 1). Following this, an open-ended explorative pilot study with 30 children and 30 adolescents explores potential illness-related cognitive biases and interoceptive accuracy before and after treatment (substudy 2). Finally, spanning across these 2 substudies, including all parents from substudies 1 and 2, we will assess parental distress and illness worries before and after treatment, and how these factors impact the treatment adherence and outcomes of the child or adolescent (substudy 3).
Recruitment of participants began in June 2022 and is finalized for substudy 1 and ongoing for substudies 2 and 3. Recruitment is expected to be completed by January 2025, with final data collection during April 2025.
The findings have the potential to contribute to the ongoing improvement of specialized psychological treatment for FAPDs in young people.
ClinicalTrials.gov NCT05237882; https://clinicaltrials.gov/study/NCT05237882; ClinicalTrials.gov NCT05486585; https://clinicaltrials.gov/study/NCT05486585; OSF Registries osf.io/c49k7; https://osf.io/c49k7.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58563.
功能性腹痛障碍（FAPDs）在年轻人中很常见，其特征是持续或反复出现腹部症状，而无明显的结构或生化异常。FAPDs与生活质量下降、缺课、医疗保健使用增加以及共病焦虑和抑郁有关。基于暴露的互联网认知行为疗法（ICBT）已证明在缓解腹部症状和改善生活质量方面有效。然而，对作用机制的更深入理解以及确定可能的额外治疗靶点可以优化治疗。
本方案文件旨在描述一项针对接受ICBT治疗FAPDs的儿童和青少年的研究，旨在进一步研究其潜在的作用机制。
患有FAPDs的儿童（8 - 12岁）、青少年（13 - 17岁）及其各自的父母将纳入为期10周的ICBT治疗。首先，通过一项涉及6名儿童和6名青少年的随机单病例设计研究（子研究1）来详细研究疗效轨迹。在此之后，一项针对30名儿童和30名青少年的开放式探索性试点研究将探讨治疗前后潜在的疾病相关认知偏差和内感受准确性（子研究2）。最后，跨越这2个子研究，包括子研究1和2中的所有父母，我们将评估治疗前后父母的痛苦和疾病担忧，以及这些因素如何影响儿童或青少年的治疗依从性和治疗结果（子研究3）。
参与者招募于2022年6月开始，子研究1已完成招募，子研究2和3仍在进行中。预计招募工作将于2025年1月完成，最终数据收集于2025年4月进行。
这些研究结果有可能为不断改进针对年轻人FAPDs的专业心理治疗做出贡献。
ClinicalTrials.gov NCT05237882；https://clinicaltrials.gov/study/NCT05237882；ClinicalTrials.gov NCT０5486585；https://clinicaltrials.gov/study/NCT05486585；OSF注册库osf.io/c49k7；https://osf.io/c４9k7。
国际注册报告标识符（IRRID）：DERR1 - 10.2196/58563。
