NCT06556251Recruiting
Effectiveness of a Digital Platform in Engagement and Prognosis of Patients in an Early Intervention Pychosis Programme
Evaluating the Effectiveness of a Digital Platform in the Engagement and Prognosis of Patients in the Early Intervention Programme in Psychosis
Source: ClinicalTrials.gov · Last updated 25 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 2 Jul 2024
- Start date
- 18 Sept 2024
- Primary completion date
- 15 Sept 2026
- Lead sponsor
- Fundació Sant Joan de Déu
- Diseases
- Schizophrenia
- NCT number
- NCT06556251
What you commit to
- Study type: Interventional
- Planned participants: 128
- From 18 Sept 2024 to the primary completion date, 15 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have had a medical condition that better explains the psychotic symptoms.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Parc Sanitari Sant Joan de Déu Coordinator of this site? Confirm its status | Sant Boi de Llobregat | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.