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

Recruiting · NCT06556251 · Interventional (participants receive a specific treatment) · Lead sponsor: Fundació Sant Joan de Déu

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Schizophrenia

Interventions studied

PIPPEP App

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.

Who can take part

Age range

18 Years to 40 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

Age between 18 and 40 years
Fulfil the criteria for one of the three groups (First Psychotic Episodes, Critical Period or Ultra High Risk of Psychosis; UHR)
To undergo community-based treatment as part of one of our facility's early intervention programmes for psychosis
Have signed the informed consent form for the study.

Exclusion criteria

No mobile phone/laptop/tablet to use the platform.
Lack of skills and/or knowledge to use the platform.
Not have knowledge of the Catalan or Spanish language.
Have a diagnosed mental disability (premorbid Intelligence Quotient \<70).
Have had a medical condition that better explains the psychotic symptoms.

Where it is running

1 location listed.

Parc Sanitari Sant Joan de Déu - Sant Boi de Llobregat, Barcelona, Spain

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →