Published: 04 February 2026
Authors: Maria Faurholt-Jepsen, Malene Schwarz Dyreholt, Natacha Blauenfeldt Kyster, Nanna Iversen, Emil Meyland Kortsen, Benedikt L. Amann, Bridget Hogg, Daniela Gatto, Cristina de Córdoba, Milica Petrovic, Caroline Allenhof, Katharina Schnitzspahn, Hanna Reich, Esben Budtz-Jørgensen, Lars Vedel Kessing, Ulrich Hegerl.
Abstract:
Depression and sub-diagnostic depressive syndromes are prevalent and are associated with suffering and reduced life expectancy. Access to care is limited, even in countries with developed healthcare systems, making it important to strengthen self-management for people experiencing depressive symptoms. This study protocol describes the MENTINA trial, a multicentre randomised controlled parallel-group trial conducted in Denmark, Germany and Spain. The trial evaluates whether daily smartphone-based monitoring and automatic rule-based feedback, combined with smartphone-based outcome evaluations, improves depressive symptoms and other clinically relevant outcomes compared with smartphone-based outcome evaluations alone. Participants with current depressive symptoms and/or one or more previous depressive episodes are followed over a 12-month trial period. The primary outcome is depressive symptom change measured using PHQ-9, with additional outcomes including quality of life, anxiety, stress, healthcare contacts, app usability, negative effects and depressive episode patterns.