Efficacy of a Transdiagnostic Internet Prevention Approach in Adolescents (EMPATIA-Study): Study Protocol of a Randomized Controlled Trial

Abstract

• Background: Most mental disorders have their onset in adolescence. Preventive interventions during this period are important, however, help-seeking behavior is generally poor in this age group resulting in low treatment rates. Internet interventions are expected to be an effective, low-threshold, and scalable approach to overcome barriers to help-seeking, particularly for individuals experiencing subclinical symptoms. Internet-delivered indicated prevention seems promising as it targets individuals with minimal symptoms of mental disorders who might need care but are not help-seeking yet. Previous indicated prevention-approaches have mainly targeted specific risk-syndromes. However, this contradicts the increasing recognition of emerging psychopathology as a complex system characterized by co-occurrence and rapid shifts of subclinical symptoms cutting across diagnostic categories. Therefore, this study will investigate the efficacy, mediators, moderators, and core symptomatic changes of a transdiagnostic internet-delivered indicated prevention program (EMPATIA-program) for adolescents. • Methods: This Randomized Controlled Trial (RCT) will be conducted in a general population sample (planned n=152) of adolescents aged 12-18 years with subclinical symptoms but without any current or past mental disorder. Participants will be randomly assigned to the EMPATIA-program or a care as usual (CAU) control condition. The 8-week guided EMPATIA-program encompasses 8 modules targeting the following transdiagnostic mechanisms: repetitive negative thinking, self-perfectionism, emotion regulation, intolerance of uncertainty, rejection sensitivity, and behavioral avoidance. Participants will be asked to answer online self-report questionnaires at baseline, after 8 weeks, and at 6-, 9-, and 12-month follow-up. Diagnostic telephone interviews will be conducted at baseline and at 12-month follow-up. Additional, intervention-specific constructs (motivation, alliance, negative effects, satisfaction, adherence) will be assessed during and after the EMPATIA-program. Level of self-reported general psychopathology post-intervention is the primary outcome. • Discussion: Results will be discussed considering the potential of internet interventions as a scalable, low-threshold option for indicated prevention in adolescents experiencing subclinical symptoms. The EMPATIA-program introduces a novel internet prevention program targeting six transdiagnostic mechanisms associated with various mental health outcomes. Thereby, this trial pursues a very timely and important topic because it may contribute to narrow the current care gap for adolescents, to prevent mental health problems and related negative consequences, and to promote mental health in the long-term. • Trial registration: The trial was approved by Swissmedic (Registration Number: 10001035, 08/22/2022) and the Ethics Committee of Bern (Registration Number: 2022-D0036, 08/22/2022). The trial was registered at ClinicalTrials.gov NCT05934019 on 07-03-2023.