Effectiveness of a Digital Platform in Engagement and Prognosis of Patients in an Early Intervention Pychosis Programme
Recruiting now · Not applicable
Conditions studied: Device Adherence
In brief
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.
Key facts
- Study ID
- NCT06556251
- Run by
- Fundació Sant Joan de Déu
- People needed
- 128
- Starts
- 2024-09-18
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-05-25
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Parc Sanitari Sant Joan de Déu — Sant Boi de Llobregat, Barcelona, Spain (enrolling)
Full record on ClinicalTrials.gov
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