Bolinski Felix, Kleiboer Annet, Karyotaki Eirini, Bosmans Judith E, Zarski Anna-Carlotta, Weisel Kiona K, Ebert David D, Jacobi Corinna, Cuijpers Pim, Riper Heleen
Department of Clinical, Neuro-, and Developmental Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, BT 1081, Amsterdam, The Netherlands.
Amsterdam Public Health research institute, Faculty of Behavioral and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Trials. 2018 Feb 20;19(1):118. doi: 10.1186/s13063-018-2477-y.
Depression and anxiety are common and co-morbid disorders that affect a significant proportion of students. Innovative prevention strategies targeting both conditions are needed to reduce their health burden and costs. ICare Prevent is such an innovative strategy and contains a transdiagnostic individually tailored Internet-based and mobile-supported intervention. It addresses common risk factors of depression and anxiety as part of a large EU-funded multi-country project* (ICare). Little is known about the clinical and cost-effectiveness of this type of intervention compared to care as usual (CAU) for college students. We hypothesize that ICare Prevent will be more (cost-)effective than CAU in the reduction of symptoms of depression and anxiety.
A three-arm, parallel, randomized controlled superiority trial will be conducted comparing a guided and an unguided version of ICare Prevent with a control group receiving CAU. The trial will be open-label but outcome assessors will be blinded. A total of 252 college students (age ≥ 16 years) with subclinical symptoms of depression defined as a score ≥ 16 on the Center for Epidemiological Studies Depression Scale (CES-D), and/or anxiety, defined as a score ≥ 5 on the Generalized Anxiety Disorder scale (GAD-7), will be included. Those meeting diagnostic criteria for a depressive or anxiety disorder will be excluded. The primary outcome is change in disorder specific symptom severity from baseline to post-intervention. Secondary endpoints include self-reported depression and anxiety symptoms as well as time to onset of a mood or anxiety disorder until 12-month follow-up. Societal costs and quality of life will be assessed to estimate the intervention's cost-effectiveness compared to CAU.
Transdiagnostic individually tailored Internet-based prevention could be a (cost-)effective approach to tackle the disease burden of depression and anxiety among college students.
Dutch trial register, NTR 6562 . Registered on 6 July 2017.
抑郁症和焦虑症是常见的共病性疾病，影响着相当比例的学生。需要针对这两种情况的创新预防策略来减轻其健康负担和成本。ICare Prevent就是这样一种创新策略，它包含一种基于互联网和移动设备支持的跨诊断个性化干预措施。作为一个由欧盟资助的大型多国项目*（ICare）的一部分，它解决了抑郁症和焦虑症的常见风险因素。与大学生常规护理（CAU）相比，这种干预措施的临床效果和成本效益鲜为人知。我们假设ICare Prevent在减轻抑郁和焦虑症状方面比CAU更具（成本）效益。
将进行一项三臂平行随机对照优势试验，比较有指导和无指导的ICare Prevent版本与接受CAU的对照组。该试验将采用开放标签，但结果评估者将保持盲态。总共将纳入252名年龄≥16岁的大学生，他们有亚临床抑郁症状，定义为在流行病学研究中心抑郁量表（CES-D）上得分≥16，和/或焦虑症状，定义为在广泛性焦虑障碍量表（GAD-7）上得分≥5。符合抑郁或焦虑症诊断标准的将被排除。主要结局是从基线到干预后特定疾病症状严重程度的变化。次要终点包括自我报告的抑郁和焦虑症状，以及直到12个月随访时情绪或焦虑症发作的时间。将评估社会成本和生活质量，以估计与CAU相比该干预措施的成本效益。
基于互联网的跨诊断个性化预防可能是一种（成本）有效的方法，以应对大学生中抑郁和焦虑的疾病负担。
荷兰试验注册库，NTR 6562。于2017年7月6日注册。
