Effects of a Novel, Transdiagnostic Ecological Momentary Intervention for Prevention, and Early Intervention of Severe Mental Disorder in Youth (EMIcompass): Findings From an Exploratory Randomized Controlled Trial

Background/Hypothesis: Digital interventions targeting transdiagnostic mechanisms in daily life may be a promising translational strategy for prevention and early intervention of psychotic and other severe mental disorders. We aimed to investigate the feasibility and initial signals of efficacy of a transdiagnostic, compassion-focused, hybrid ecological momentary intervention for improving resilience (ie, EMIcompass) in youth with early mental health problems. Study Design: In an exploratory, assessorblind randomized controlled trial, youth aged 14-25 with current distress, broad at-risk mental state, or first episode of severe mental disorder were randomly allocated to experimental (EMIcompass+ treatment as usual [ TAU]) or control condition (TAU). Data on primary (stress reactivity) and secondary candidate mechanisms as well as candidate primary (psychological distress) and secondary outcomes were collected. Study Results: Criteria for the feasibility of trial methodology and intervention delivery were met (n = 92 randomized participants). No serious adverse events were observed. Initial outcome signals were evident for reduced momentary stress reactivity (stressxtimexcondition, B = -0.10 95%CI -0.16--0.03, d = -0.10), aberrant salience (condition, B = -0.38, 95%CI -0.57--0.18, d = -0.56) as well as enhanced momentary resilience (condition, B = 0.55, 95%CI 0.180.92, d = 0.33) and quality of life (condition, B = 0.82, 95%CI 0.10-1.55, d = 0.60) across post-intervention and 4-week follow-up. No outcome signals were observed for self-reported psychological distress (condition, B = 0.57, 95%CI -1.59-2.72, d = 0.09), but there was suggestive evidence of reduced observer-rated symptoms at the 4-week follow-up (B = -1.41, 95%CI -2.85-0.02, d = -0.41). Conclusions: Our findings provide evidence of feasibility and initial signals that EMIcompass may reduce stress reactivity and improve quality of life. A definitive trial is now warranted.