Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden; Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.
Division of Psychology, Karolinska Institutet, Stockholm, Sweden; Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Clin Gastroenterol Hepatol. 2019 Oct;17(11):2236-2244.e11. doi: 10.1016/j.cgh.2018.11.043. Epub 2018 Nov 28.
BACKGROUND & AIMS: Scalable and effective treatments are needed for children with functional abdominal pain disorders (FAPDs). We performed a randomized controlled trial of the efficacy and cost effectiveness of cognitive behavioral therapy delivered online (Internet-CBT) compared with usual therapy. METHODS: We studied children (age, 8-12 y) diagnosed with FAPDs, based on the Rome IV criteria, in Sweden from September 2016 through April 2017. The patients were assigned randomly to groups that received 10 weeks of therapist-guided, internet-delivered cognitive behavioral therapy (Internet-CBT, n = 46) or treatment as usual (treatments within the health care and school systems, including medications and visits to doctors and other health care professionals; n = 44). The primary outcome was global child-rated gastrointestinal symptom severity assessed using the Pediatric Quality of Life Gastrointestinal Symptom scale. All outcomes were collected from September 2016 through January 2018. Secondary outcomes included quality of life, gastrointestinal-specific anxiety, avoidance behaviors, and parental responses to children's symptoms. Societal costs and costs for health care consumption were collected during the treatment. RESULTS: Children who received Internet-CBT had a significantly larger improvement in gastrointestinal symptom severity with a medium effect size (Cohen's d = 0.46; 95% CI, 0.05-0.88; number needed to treat, 3.8) compared with children who received the treatment as usual. The children's quality of life, gastrointestinal-specific anxiety, avoidance behaviors, and parental responses to children's symptoms also improved significantly in the Internet-CBT group compared with the treatment as usual group. The effects of Internet-CBT persisted through 36 weeks of follow-up evaluation. Children who received Internet-CBT had significantly less health care use than children who received treatment as usual, with an average cost difference of US $137 (P = .011). We calculated a cost savings of US $1050 for every child treated with Internet-CBT compared with treatment as usual. CONCLUSIONS: In a randomized trial of pediatric patients with FAPDs, we found Internet-CBT to be clinically cost effective compared with treatment as usual. Internet-CBT has the potential to increase the availability of treatment for a number of patients and reduce health care costs. ClinicalTrials.gov: NCT02873078.
背景与目的：需要为功能性腹痛障碍（FAPD）患儿提供可扩展且有效的治疗方法。我们对在线认知行为疗法（互联网-CBT）与常规治疗相比的疗效和成本效益进行了一项随机对照试验。
方法：我们于 2016 年 9 月至 2017 年 4 月在瑞典研究了根据罗马 IV 标准诊断为 FAPD 的儿童患者。这些患者被随机分为两组，一组接受 10 周的治疗师指导、互联网提供的认知行为疗法（互联网-CBT，n=46），另一组接受常规治疗（卫生保健和学校系统内的治疗，包括药物治疗和就诊于医生和其他卫生保健专业人员；n=44）。主要结局是使用儿科生活质量胃肠道症状量表评估的儿童自评胃肠道症状严重程度。所有结局均于 2016 年 9 月至 2018 年 1 月收集。次要结局包括生活质量、胃肠道特异性焦虑、回避行为和父母对儿童症状的反应。在治疗期间收集社会成本和卫生保健消费成本。
结果：与接受常规治疗的患儿相比，接受互联网-CBT 的患儿胃肠道症状严重程度的改善程度显著更大，具有中等效应量（Cohen's d=0.46；95%CI，0.05-0.88；需要治疗的人数，3.8）。与接受常规治疗的患儿相比，接受互联网-CBT 的患儿的生活质量、胃肠道特异性焦虑、回避行为和父母对儿童症状的反应也显著改善。在 36 周的随访评估中，互联网-CBT 的效果持续存在。与接受常规治疗的患儿相比，接受互联网-CBT 的患儿的卫生保健使用显著减少，平均成本差异为 137 美元（P=0.011）。我们计算出，与接受常规治疗相比，每治疗一名患儿，通过互联网-CBT 可节省 1050 美元。
结论：在一项针对 FAPD 儿科患者的随机试验中，我们发现互联网-CBT 与常规治疗相比具有临床成本效益。互联网-CBT 有可能增加许多患者的治疗机会并降低医疗保健成本。ClinicalTrials.gov：NCT02873078。
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