PDF(Pubmed)
Abstract：
BACKGROUND: Most mental disorders have their onset in adolescence. Preventive interventions during this period are important; however, help-seeking behavior is generally poor in this age group resulting in low treatment rates. Internet interventions are expected to be an effective, low-threshold, and scalable approach to overcome barriers to help-seeking, particularly for individuals experiencing subclinical symptoms. Internet-delivered indicated prevention seems promising as it targets individuals with minimal symptoms of mental disorders who might need care but are not help-seeking yet. Previous indicated prevention-approaches have mainly targeted specific risk-syndromes. However, this contradicts the increasing recognition of emerging psychopathology as a complex system characterized by co-occurrence and rapid shifts of subclinical symptoms cutting across diagnostic categories. Therefore, this study will investigate the efficacy, mediators, moderators, and core symptomatic changes of a transdiagnostic Internet-delivered indicated prevention program (EMPATIA program) for adolescents.
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.
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.
摘要：
背景：大多数精神障碍在青春期发病。在此期间的预防性干预很重要；然而，这个年龄组的求助行为普遍较差，导致治疗率低。互联网干预预计将是有效的，低门槛,以及可扩展的方法来克服寻求帮助的障碍，特别是对于经历亚临床症状的个体。互联网提供的指示预防似乎很有希望，因为它针对的是可能需要护理但尚未寻求帮助的精神障碍症状最小的个体。先前指出的预防方法主要针对特定的风险综合征。然而,这与人们日益认识到新出现的精神病理学是一个复杂的系统相矛盾,该系统的特征是亚临床症状在不同诊断类别之间同时发生和快速转移.因此,这项研究将调查疗效，调解员,主持人,以及针对青少年的经诊断互联网提供的指示预防计划（EMPATIA计划）的核心症状变化。
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。
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。
