Fundació Sant Joan de Déu

The main aim of the clinical trial is to validate the Machin Learning (ML) predictive model for personalized Metacognitive Training (MCT) by comparing classic MCT to personalized MCT (P-MCT) among patients diagnosed with psychosis who had a history of delusions. More precisely, we will compare classic MCT to P-MCT in a randomized clinical trial.We expect personalised MCT treatment will see more improvement than classical MCT in outcome variables measuring treatment efficacy.

This is a randomised, prospective, controlled trial in which one group (experimental group; GE) receives access to the PIPPEP (Intervention Programme for Early Psychosis) platform in addition to the treatment as usual (TAU) in PIPPEP, while the other group (control group; GC) receives only TAU in PIPPEP.
Main objective:
- To assess whether the use of the PIPPEP platform improves psychosocial and pharmacological treatment adherence in mental health programmes.
Secondary objectives:
* To assess the cost-effectiveness of the PIPPEP app.
* Evaluation of the dissemination of the platform.
* To assess the clinical and functional outcomes of patients using the PIPPEP platform in terms of 1) positive symptoms, 2) side effects of antipsychotic medication, 3) perceived social self-stigma, 4) risk assessment, 5) comorbid symptoms and 6) social functioning
The participants are 1) between 18 and 40 years of age, who are being treated in one of the PIPPEP programmes for early intervention in psychosis at Sanitary Parc Sant Joan de Déu and who meet the inclusion criteria "extremely high risk of psychosis", "critical phase or "first psychotic episode" and 2) agree to participate in the study and sign the informed consent form.

The e-Intervention Enhancing Mental Health in Adolescents (IMPROVA) study will co-design, test, evaluate, and facilitate the upscaling of a modular eHealth intervention platform that aims to improve mental health and wellbeing, early detect mental health problems and prevent common mental problems in adolescents. IMPROVA will be implemented in school settings and will include components for adolescents, parents, teachers, and other school staff in complementary and synergistic modules based on materials designed and tested in >20 projects carried out by the consortium members. After alpha, beta and pilot testing of the platform, the IMPROVA program will be implemented via a randomised controlled trial in secondary education schools in France, Germany, Romania and Spain, including approximately 6,000 adolescents. A 360º evaluation of IMPROVA will include Effectiveness, Implementation, Economic, and Social Return on Investment analysis. The primary outcome to assess the effectiveness of the IMPROVA program is the overall mental health of adolescents. A series of secondary outcomes will also evaluate the potential impact of the platform on other health-related outcomes (e.g., wellbeing, social isolation, anxiety, life satisfaction). Using implementation science methodology, IMPROVA will co-design transferable evidence-based guidance for scaling up the platform with users and policymakers. IMPROVA aims to provide an evidence-based, innovative, large-scale, comprehensive intervention, and a scale-up plan to promote mental health and prevent mental disorders in adolescents; empower adolescents and families to make better decisions regarding their mental health; and provide schools and the community with tools to achieve a society with better mental health and lower stigma.