METHODS: This randomized controlled trial (RCT) will be conducted in a general population sample (planned n = 152) of adolescents aged 12-18 years with subclinical symptoms but without any current or past mental disorder. Participants will be randomly assigned to the EMPATIA program or a care as usual (CAU) control condition. The 8-week guided EMPATIA program encompasses 8 modules targeting the following transdiagnostic mechanisms: repetitive negative thinking, self-perfectionism, emotion regulation, intolerance of uncertainty, rejection sensitivity, and behavioral avoidance. Participants will be asked to answer online self-report questionnaires at baseline, after 8 weeks, and at 6-, 9-, and 12-month follow-up. Diagnostic telephone interviews will be conducted at baseline and at 12-month follow-up. Additionally, intervention-specific constructs (motivation, alliance, negative effects, satisfaction, adherence) will be assessed during and after the EMPATIA program. The level of self-reported general psychopathology post-intervention is the primary outcome.
CONCLUSIONS: Results will be discussed considering the potential of Internet interventions as a scalable, low-threshold option for indicated prevention in adolescents experiencing subclinical symptoms. The EMPATIA program introduces a novel Internet prevention program targeting six transdiagnostic mechanisms associated with various mental health outcomes. Thereby, this trial pursues a very timely and important topic because it may contribute to narrow the current care gap for adolescents, to prevent mental health problems and related negative consequences, and to promote mental health in the long-term.
BACKGROUND: The trial was approved by Swissmedic (Registration Number: 10001035, 08/22/2022) and the Ethics Committee of Bern (Registration Number: 2022-D0036, 08/22/2022). The trial was registered at ClinicalTrials.gov NCT05934019 on 07-03-2023.
方法:这项随机对照试验(RCT)将在12-18岁有亚临床症状但没有任何当前或过去精神障碍的青少年的一般人群样本中进行(计划n=152)。参与者将被随机分配到EMPATIA计划或照常护理(CAU)控制条件。为期8周的指导EMPATIA计划包括针对以下跨诊断机制的8个模块:重复的负面思维,自我完美主义,情绪调节,不容忍的不确定性,排斥敏感性,和行为回避。参与者将被要求在基线时回答在线自我报告问卷,8周后,在6-,9-,和12个月的随访。诊断性电话访谈将在基线和12个月随访时进行。此外,特定于干预的结构(动机,联盟,负面影响,满意,依从性)将在EMPATIA计划期间和之后进行评估。干预后自我报告的一般精神病理学水平是主要结果。
结论:将讨论结果,考虑到互联网干预的潜力,在出现亚临床症状的青少年中进行指示性预防的低阈值选择。EMPATIA计划引入了一项新颖的互联网预防计划,针对与各种心理健康结果相关的六种跨诊断机制。因此,这项试验追求一个非常及时和重要的话题,因为它可能有助于缩小目前对青少年的护理差距,防止心理健康问题和相关的负面后果,长期促进心理健康。
背景:该试验获得了Swissmedic(注册号:10001035,08/22/2022)和伯尔尼伦理委员会(注册号:2022-D0036,08/22/2022)的批准。该试验于2023年3月7日在ClinicalTrials.govNCT05934019注册。