Kaiser Sabine, Rye Marte, Jakobsen Reidar, Martinussen Monica, Høgsdal Helene, Kyrrestad Henriette
Regional Centre for Child and Youth Mental Health and Child Welfare - North, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.
Department of Clinical Psychology, Faculty of Psychology, University of Bergen, Bergen, Norway.
JMIR Res Protoc. 2023 Jan 11;12:e42119. doi: 10.2196/42119.
In times of increasing mental health problems among young people, strengthening efforts to improve mental health through mental health promotion and prevention becomes increasingly important. Effective measures that support young people in coping with negative thoughts, feelings, and stress are essential, not just for the individual but also for society.
The aim of this paper is to provide a description of a cluster randomized controlled trial that will be conducted to examine the effectiveness of Opp, a universal mental health-promoting mobile app for adolescents aged 13 to 19 years that provides information and exercises to better cope with stress, negative thoughts, and negative feelings. The protocol was developed in accordance with the SPIRIT checklist.
An effectiveness study will be conducted with 3 measurement points: preintervention (T1), 2 weeks after the intervention (T2), and about 1 month after the intervention (T3). Adolescents will be recruited from middle and high schools in Norway and randomly assigned to the intervention or control groups. Randomization will be conducted on the school level. Opp can be downloaded from the Google Play or App Store but is password protected with a 4-digit code, which will be removed after study completion. Participants in the intervention group will receive a text message with the code to unlock the app. The participants in the intervention group can use Opp without limits on length or time of use. Objective data on how long or how often the participants use the app will not be collected. However, the second and third questionnaires for the intervention group contain app-specific questions on, for example, the use of the app.
Recruitment and data collection started in August and September 2022. So far, 381 adolescents have answered the first questionnaire. Data collection was expected to end in December 2022 but has had to be prolonged to approximately June 2023. The results of the study will be available in 2023 at the earliest.
This project will contribute unique knowledge to the field, as there are few studies that have examined the effects of universal health-promoting mobile apps for adolescents. However, several limitations have to be taken into account when interpreting the results, such as randomization on the school level, the short time frame in which the study was conducted, and the lack of objective data to monitor the use of the app.
ClinicalTrials.gov NCT05211713; https://www.clinicaltrials.gov/ct2/show/NCT05211713.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/42119.
在年轻人心理健康问题日益增多的时代，通过心理健康促进和预防来加强改善心理健康的努力变得越来越重要。支持年轻人应对消极思想、情绪和压力的有效措施至关重要，这不仅对个人，对社会也同样重要。
本文旨在描述一项整群随机对照试验，该试验将用于检验Opp这款面向13至19岁青少年的通用心理健康促进移动应用程序的有效性。该应用程序提供信息和练习，以更好地应对压力、消极思想和消极情绪。研究方案是根据SPIRIT清单制定的。
将进行一项有效性研究，有3个测量点：干预前（T1）、干预后2周（T2）和约干预后1个月（T3）。青少年将从挪威的初中和高中招募，并随机分配到干预组或对照组。随机化将在学校层面进行。Opp可以从谷歌Play或应用商店下载，但有4位数字密码保护，研究结束后将取消密码。干预组的参与者将收到一条带有解锁应用程序代码的短信。干预组的参与者可以无限制地使用Opp，使用时长和时间不限。不会收集关于参与者使用该应用程序时长或频率的客观数据。然而，干预组的第二份和第三份问卷包含关于该应用程序使用情况的特定问题，例如应用程序的使用情况。
招募和数据收集于2022年8月和9月开始。到目前为止，已有381名青少年回答了第一份问卷。数据收集预计于2022年12月结束，但不得不延长至大约2023年6月。该研究结果最早将于2023年公布。
该项目将为该领域贡献独特的知识，因为很少有研究考察过面向青少年的通用健康促进移动应用程序的效果。然而，在解释研究结果时必须考虑到几个局限性，例如在学校层面进行随机化、研究开展的时间框架较短以及缺乏监测应用程序使用情况的客观数据。
ClinicalTrials.gov NCT05211713；https://www.clinicaltrials.gov/ct2/show/NCT05211713。
国际注册报告识别号（IRRID）：PRR1-10.2196/42119。
