Krokos Olivia, Brandhorst Isabel, Seizer Lennart, Gawrilow Caterina, Löchner Johanna
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, Tuebingen, Germany.
German Center for Mental Health (DZPG), Germany.
Internet Interv. 2024 Mar 7;36:100733. doi: 10.1016/j.invent.2024.100733. eCollection 2024 Jun.
From the age of 14, many adolescents enter a vulnerable developmental phase, with a sharp increase in mental illness at 16. The COVID19 pandemic has further exacerbated this issue. Hence, universal and easily accessible prevention in the young is needed. -mental health interventions are on the rise due to numerous benefits such as potential low-costs, low-threshold and high scalability. However, effectiveness and acceptance of mobile health (mHealth) preventive interventions remain unresearched.
In a two-armed, randomised controlled study design adolescents and young adults from 14 years old will be recruited. Following an initial baseline assessment, they will be randomised to a) the intervention group (IG, = 75), which will receive a mHealth intervention (the application 'Mental Health Guide', co-developed by lived experience experts) or b) the waiting list control group (CG, = 75). Both groups will be followed up after 3 and 6 months following post assessment. We hypothesize an increase in mental health literacy in the IG compared to the CG for post and follow-up assessment (primary outcome: Mental Health Literacy Scale). In addition, we expect an improvement in mental health and psychological well-being, improved emotion regulation, reduced psychological distress, as well as good quality ratings in usability and acceptance in the use of the 'Mental Health Guide' We performed multiple simulations of possible outcome scenarios, incorporating an array of factors, to generate realistic datasets and obtain accurate estimates of statistical power.
As a first-of-its-kind in this field, this study investigates whether a mHealth intervention based on mental health literacy may improve the mental health literacy and further aspects of psychological functioning of young people in a vulnerable phase. Furthermore, the results promise to provide important knowledge of how universal prevention may be implemented with low costs for diverse populations.
This trial was registered in the DRKS register (DRKS-ID: DRKS00031810) on 23 June 2023.
从14岁起,许多青少年进入一个易受影响的发育阶段,16岁时精神疾病发病率急剧上升。新冠疫情进一步加剧了这一问题。因此,需要针对年轻人开展普遍且易于获得的预防措施。由于潜在低成本、低门槛和高可扩展性等诸多益处,心理健康干预措施正在增加。然而,移动健康(mHealth)预防性干预措施的有效性和接受度仍未得到研究。
在一项双臂随机对照研究设计中,将招募14岁及以上的青少年和青年。在进行初始基线评估后,他们将被随机分为:a)干预组(IG,n = 75),将接受移动健康干预(应用程序“心理健康指南”,由有实际生活经验的专家共同开发);或b)等待名单对照组(CG,n = 75)。在评估后3个月和6个月对两组进行随访。我们假设与对照组相比,干预组在评估后和随访时心理健康素养会有所提高(主要结局:心理健康素养量表)。此外,我们预计心理健康和幸福感会得到改善,情绪调节能力会提高,心理困扰会减少,并且在使用“心理健康指南”时,可用性和接受度的质量评级会良好。我们对可能的结局情景进行了多次模拟,纳入一系列因素,以生成现实数据集并获得统计功效的准确估计值。
作为该领域的首个此类研究,本研究调查基于心理健康素养的移动健康干预措施是否可以提高处于易受影响阶段的年轻人的心理健康素养以及心理功能的其他方面。此外,研究结果有望提供关于如何以低成本对不同人群实施普遍预防的重要知识。
本试验于2023年6月23日在德国临床试验注册中心(DRKS)注册(DRKS-ID:DRKS00031810)。