Web-based indicated prevention of common mental disorders in university students in four European countries – Study protocol for a randomised controlled trial

Abstract

BackgroundMental disorders and their symptoms are highly prevalent in the university student population, and the transition from secondary to tertiary education is associated with a rise in mental health problems. Existing web-based interventions for the prevention of common mental disorders in student populations often focus on just one disorder and have not been designed specifically for students. There is thus a need for transdiagnostic, student-specific preventative interventions that can be widely disseminated. This two-arm, parallel group randomised controlled trial aims to evaluate the effectiveness and cost-effectiveness of a web-based transdiagnostic mental health problem prevention programme (PLUS) across several universities in four countries.MethodStudents (N = 5550) will be recruited through a variety of channels and asked to complete a personality assessment to determine whether they are at high risk for developing common mental disorders. Students at high risk will be randomly allocated to either PLUS or a control intervention, which provides practical support around issues commonly experienced at university. Students at low risk will be allocated to the control intervention. Both intervention groups will be assessed at baseline, 4 weeks, 3 months, 6 months and 12 months after randomisation. Depression and generalised anxiety, assessed using the Patient Health Questionnaire and the Generalised Anxiety Disorder scales, will form the primary outcomes in this study. Secondary outcome measures include alcohol and drug use, eating behaviour, self-esteem, and quality of life. The cost-effectiveness of the intervention will also be evaluated.ConclusionsThis study will contribute to understanding the role of transdiagnostic indicated web-based interventions for the prevention of common mental disorders in university students. It will also be one of the first studies to investigate the cost-effectiveness of such interventions.Trial RegistrationThis trial was registered in the ISRCTN register (ISRCTN15570935) on 12th February 2016.

Exploring the feasibility and acceptability of the contents, design, and functionalities of an online intervention promoting mental health, wellbeing, and study skills in Higher Education students

“…Recent studies have shown great progress with the use of online support systems as interactive interventions, demonstrating their positive impact on accessibility and their flexibility [38, 39]. Furthermore, effects have been shown to be longitudinal, with self-reported symptoms significantly reduced 12 months post participation [40, 41].…”

Special issue internet interventions: Editorial “integrating technology into mental health care delivery in Europe (ICare)”

“…Jones Bell et al (2018) describe the study protocol of an RCT conducted in Austria and Spain, evaluating unguided or mobile-based prevention of eating disorders and obesity in adolescents in school settings. Musiat et al (2018) present the study protocol of a randomized controlled prevention trial. The focus of this trial is on personality traits as a risk factor for common mental health disorders in university students from UK, Austria and Germany.…”

Implementing online interventions in ICare: A biostatistical perspective

“…During the planning phase, we defined the research hypotheses, selected the most appropriate outcome parameters, formulated statistical (null) hypotheses to prove the primary research questions, selected statistical test procedures and performed power calculations to determine the necessary sample sizes. For the details of each study please see the individual study protocols (Vollert et al, 2018; Nacke et al, 2018; Herrero et al, 2018; Weisel et al, 2018; Jones Bell et al, 2018; Musiat et al, 2018; Spencer et al, 2018). ICare trials target a variety of primary outcomes, such as short-term effects (e.g., reduction of scores at post-measurement), long-term effects (e.g., reduction of target scores at follow-up measurements).…”

“…Effect size estimates are based on published literature. For details on the study specific effect size estimates and power calculations please see the individual study protocols (Vollert et al, 2018; Nacke et al, 2018; Herrero et al, 2018; Weisel et al, 2018; Jones Bell et al, 2018; Musiat et al, 2018; Spencer et al, 2018). Sample sizes were calculated using the following software: G*Power (Faul et al, 2007), PASS (Hintze, 2014; PASS 13.…”