Adolescents and young adults (AYA) with chronic somatic conditions have an increased risk of comorbid depression and anxiety symptoms. Internet- and mobile-based cognitive behavioural therapy (iCBT) might be one possibility to extend the access to evidence-based treatments. Studies suggest that guided iCBT can reduce anxiety and depression symptoms in AYA. However, little is known about the effectiveness of iCBT for AYA with chronic somatic conditions and comorbid symptoms of anxiety and/or depression in routine care. Evidence on the (cost-)effectiveness of iCBT is essential for its implementation in health care. This multicentre two-armed randomized controlled trial (RCT) aims to evaluate the (cost-) effectiveness of guided iCBT (youthCOACHCD) in addition to treatment as usual (TAU) compared to enhanced treatment as usual (TAU+) in AYA aged 12–21 years with one of three chronic somatic conditions (type 1 diabetes, cystic fibrosis, or juvenile idiopathic arthritis). AYA with one of the chronic somatic conditions and elevated symptoms of anxiety or depression (Patient Health Questionnaire [PHQ-9] and/or Generalized Anxiety Disorder [GAD-7] Screener score ≥ 7) will be eligible for inclusion. We will recruit 212 patients (2 × n = 106) in routine care through three German patient registries. Assessments will take place at baseline and at 6 weeks, 3 months, 6 months, and 12 months post-randomization. The primary outcome will be combined depression and anxiety symptom severity as measured with the PHQ Anxiety and Depression Scale. Secondary outcomes will include health-related quality of life, coping strategies, self-efficacy, stress-related personal growth, social support, behavioural activation, adjustment and trauma-related symptoms, automatic thoughts, intervention satisfaction, working alliance, and Internet usage. The cost-effectiveness will be determined, and potential moderators and mediators of intervention effects will be explored. iCBT might implicate novel ways to increase the access to evidence-based interventions in this specific population. The distinct focus on effectiveness and cost-effectiveness of youthCOACHCD in patients with chronic somatic conditions, as well as intervention safety, will most likely provide important new insights in the field of paediatric e-mental health. A particular strength of the present study is its implementation directly into routine collaborative health care. As such, this study will provide important insights for health care policy and stakeholders and indicate how iCBT can be integrated into existing health care systems. German Clinical Trials Register (DRKS), DRKS00017161. Registered on 17 September 2019.

中文翻译：

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针对患有慢性躯体疾病以及共病抑郁和焦虑症状的青少年和年轻人的基于互联网和移动设备的指导性 CBT 的有效性和成本效益 (youthCOACHCD)：多中心随机对照试验的研究方案


患有慢性躯体疾病的青少年和年轻人 (AYA) 合并抑郁和焦虑症状的风险增加。基于互联网和移动设备的认知行为疗法（iCBT）可能是扩大循证治疗范围的一种可能性。研究表明，引导式 iCBT 可以减轻 AYA 的焦虑和抑郁症状。然而，在常规护理中，对于 iCBT 对患有慢性躯体疾病以及焦虑和/或抑郁共病症状的 AYA 的有效性知之甚少。 iCBT 的（成本）效益证据对于其在医疗保健领域的实施至关重要。这项多中心双臂随机对照试验 (RCT) 旨在评估 12-21 岁 AYA 中除了常规治疗 (TAU) 之外，引导 iCBT (youthCOACHCD) 与常规强化治疗 (TAU+) 的（成本）有效性患有三种慢性躯体疾病之一（1 型糖尿病、囊性纤维化或幼年特发性关节炎）的年数。患有一种慢性躯体疾病且焦虑或抑郁症状加重（患者健康问卷 [PHQ-9] 和/或广泛性焦虑症 [GAD-7] 筛查评分 ≥ 7）的 AYA 将符合纳入资格。我们将通过三个德国患者登记处招募 212 名患者 (2 × n = 106) 进行常规护理。评估将在基线以及随机化后 6 周、3 个月、6 个月和 12 个月时进行。主要结果是使用 PHQ 焦虑和抑郁量表测量的抑郁和焦虑症状的严重程度。 次要结果将包括与健康相关的生活质量、应对策略、自我效能、与压力相关的个人成长、社会支持、行为激活、调整和创伤相关症状、自动思维、干预满意度、工作联盟和互联网使用。将确定成本效益，并探索干预效果的潜在调节因素和中介因素。 iCBT 可能意味着增加该特定人群获得循证干预措施的机会的新方法。 YouthCOACHCD 对慢性躯体疾病患者的有效性和成本效益以及干预安全性的独特关注很可能为儿科电子心理健康领域提供重要的新见解。本研究的一个特殊优势是将其直接实施到常规协作医疗保健中。因此，这项研究将为医疗保健政策和利益相关者提供重要的见解，并表明如何将 iCBT 整合到现有的医疗保健系统中。德国临床试验注册中心 (DRKS)，DRKS00017161。注册日期：2019 年 9 月 17 日。