NCT06556251 Effectiveness of a Digital Platform in Engagement and Prognosis of Patients in an Early Intervention Pychosis Programme
| NCT ID | NCT06556251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundació Sant Joan de Déu |
| Condition | Device Adherence |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2024-09-18 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2024-09-18 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06556251 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Device Adherence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06556251 currently recruiting?
Yes, NCT06556251 is actively recruiting participants. Contact the research team at mtrinidad.pelaez@sjd.es for enrollment information.
Where is the NCT06556251 trial being conducted?
This trial is being conducted at Sant Boi de Llobregat, Spain.
Who is sponsoring the NCT06556251 clinical trial?
NCT06556251 is sponsored by Fundació Sant Joan de Déu. The trial plans to enroll 128 participants.