Effectiveness of a Digital Platform in Engagement and Prognosis of Patients in an Early Intervention Pychosis Programme

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.

NCT Number	NCT06556251
Lead Sponsor	Fundació Sant Joan de Déu Collaborators: Parc Sanitari Sant Joan de Déu
Conditions	Device Adherence
Enrollment	128 participants
Start Date	2024-09-18
Primary Completion	2026-09-15 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-25