Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
NCT06556251

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

Led by Fundació Sant Joan de Déu · Updated on 2025-05-25

128

Participants Needed

1

Research Sites

171 weeks

Total Duration

On this page

Sponsors

F

Fundació Sant Joan de Déu

Lead Sponsor

P

Parc Sanitari Sant Joan de Déu

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 40 years
  • Meet criteria for First Psychotic Episode, Critical Period, or Ultra High Risk of Psychosis
  • Receiving community-based treatment in an early intervention psychosis program
  • Have signed the informed consent form to participate in the study
Not Eligible

You will not qualify if you...

  • Do not have a mobile phone, laptop, or tablet to use the platform
  • Lack skills or knowledge to use the platform
  • Do not understand Catalan or Spanish
  • Have a diagnosed mental disability with premorbid IQ below 70
  • Have a medical condition better explaining the psychotic symptoms

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Parc Sanitari Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, Spain, 08830

Actively Recruiting

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Research Team

M

MARIA TRINIDAD PELÁEZ MARTÍNEZ

CONTACT

A

ALICIA COLOMER SALVANS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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