The effects of a novel, transdiagnostic, hybrid ecological momentary intervention for improving resilience in youth (EMIcompass): study protocol for an exploratory randomized controlled trial

Background: Most mental disorders first emerge in youth and, in their early stages, surface as subthreshold expressions of symptoms comprising a transdiagnostic phenotype of psychosis, mania, depression and anxiety. Elevated stress reactivity is one of the most widely studied mechanisms underlying psychotic and affective mental health problems. Thus, targeting stress reactivity in youth is a promising indicated and translational preventive strategy for adverse mental health outcomes later in life and for improving resilience. Compassion-focused interventions (CFIs) offer a wide range of innovative therapeutic techniques particularly amenable to being implemented as Ecological Momentary Interventions (EMIs), a specific type of mHealth intervention, to enable youth to access interventions in a given moment and context in daily life. This approach may bridge a gap in current youth mental health care. Objectives: The aim of this study will be to investigate the clinical feasibility, candidate underlying mechanisms and initial signals of efficacy of a novel, transdiagnostic, hybrid EMI for improving resilience to stress in youth (EMIcompass). Methods: In an exploratory randomized controlled trial (RCT), youth aged 14-25 with current distress, a broad Clinical High At-Risk Mental State (CHARMS) or a first episode of a severe mental disorder will be randomly allocated to the EMIcompass intervention (EMI plus face-to-face training sessions) in addition to treatment as usual (TAU) or a control condition of TAU only. Primary (stress reactivity) and secondary candidate mechanisms (resilience, interpersonal sensitivity, threat anticipation, negative affective appraisals, momentary physiological markers of stress reactivity) as well as primary (psychological distress) and secondary outcomes (primary psychiatric symptoms, general psychopathology) will be assessed at baseline, post-intervention and 4-week follow-up. Results: The first enrolment was in August 2019 and as of May 2021, enrolment and randomization has been completed (n = 92 participants). We expect the end of data collection in August 2021. Conclusions: The current study is the first to establish feasibility, evidence on underlying mechanisms, and preliminary signals of efficacy of a compassion-focused EMI in youth. If successful, a confirmatory RCT will be warranted. Overall, our approach has the potential to significantly advance preventive interventions in youth mental health provision. Trial registration: German Clinical Trials Register (DRKS), DRKS00017265; Date of registration: 31.07.2019.