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

21 Pages Posted: 4 Oct 2023

See all articles by Olivia Krokos

Olivia Krokos

University of Tuebingen

Isabel Brandhorst

University of Tuebingen

Lennart Seitzer

University of Tuebingen

Caterina Gawrilow

University of Tuebingen

Johanna Löchner

University of Tuebingen

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

Suggested Citation

Krokos, Olivia and Brandhorst, Isabel and Seitzer, Lennart and Gawrilow, Caterina and Löchner, Johanna, 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. Available at SSRN: https://ssrn.com/abstract=4586047 or http://dx.doi.org/10.2139/ssrn.4586047

Olivia Krokos

University of Tuebingen ( email )

Isabel Brandhorst

University of Tuebingen ( email )

Lennart Seitzer

University of Tuebingen ( email )

Caterina Gawrilow

University of Tuebingen ( email )

Tübingen, 72074
Germany

Johanna Löchner (Contact Author)

University of Tuebingen ( email )

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