Improving Mental Health by Improving the Mental Health Literacy? Study Protocol and Trial Simulation for a Randomized Controlled Evaluation of an E-Mental Health Application as a Preventive Intervention for Adolescents and Young Adults

Abstract

Background: 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. E-mental health interventions are on the rise due to numerous benefits as potential low-costs, low-threshold and high scalability. However, effectiveness and acceptance of mobile health (mHealth) preventive interventions are still outstanding.

Method: 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, n=75), which will receive a mHealth intervention (the application ‘Mental Health Guide’, co-developed by lived experience experts) or b) the wait list control group (CG, n=75). Both groups will be followed up 3 and 6 months after 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: MHLS). In addition, we expect an improvement in mental health and psychological well-being (SDQ, WHO5, MDBF), improved emotion regulation (DERS-SF), reduced psychological distress (PSS4), as well as good quality ratings in usability and acceptance in the use of the ‘Mental Health Guide’ (MARS-G). We performed multiple simulations of possible outcome scenarios, incorporating an array of factors, to generate realistic datasets and obtain accurate estimates of statistical power.

Conclusion: As 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.1Trial Registration: This trial was registered in the DRKS register (DRKS-ID: DRKS00031810) on 23 June 2023.

Note:
Funding Declaration: This study is financed by own funds (appointment funds Prof. Löchner). We acknowledge support by Open Access Publishing Fund of University of Tübingen.

Conflicts of Interest: None

Ethical Approval: The study design is reported in line with the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials; Chan et al., 2013), has received approval from the ethical committee of the Universitaetsklinikum Tuebingen (Ref no. 842/2022BO1, June 2023), and is in line with the Declaration of Helsinki (‘World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects’, 2013), and has received approval from the German ministry of education (Ref. no. KM31-6499- 3/115/3).

Trial Registration: The study was registered in the German register for clinical trials (DRKS-ID: DRKS00031810).

Keywords: mHealth, mental health literacy, adolescence, prevention