RecruitingNot ApplicableNCT06556251

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

Sponsor

Fundació Sant Joan de Déu

Enrollment

128 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

Device Adherence

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

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a digital app platform can help engage and improve outcomes for young adults experiencing their first episode of psychosis or who are at very high risk of developing psychosis and are enrolled in an early intervention program. **You may be eligible if...** - You are between 18 and 40 years old - You are in one of three groups: first psychotic episode, critical period after psychosis, or at ultra-high risk for psychosis - You are participating in a community-based early intervention program at the clinic - You have signed informed consent **You may NOT be eligible if...** - You do not have access to a smartphone, laptop, or tablet to use the platform - You lack the skills to use digital technology - You do not understand Catalan or Spanish - You have a diagnosed intellectual disability (IQ below 70) - Your psychotic symptoms are better explained by a medical condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPIPPEP App

Digital platform with psichoeducative content in infographics, animated and testimonial videos about: * psychotic and comorbid symptoms, substance use, available treatments, healthy lifestyle habits, social and health emergency resources and outpatient clinics for young people. * Regular self-completed questionnaires to measure alarm symptoms, side effects of pharmacological treatment, emotional state, and treatment adherence. There will be a feedback for patients in the form of graphs of the evolution of the different types of questionnaires. * A bidirectional messaging service with the professional reference team, allowing better accessibility in non-urgent cases. * A gamification system to encourage use of the application, which includes points, rewards, a leaderboard and mini-games. * A folder where patients can keep documents they find useful (personal reports, relapse prevention plan, crisis plan).

Locations(1)

Parc Sanitari Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, Spain

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NCT06556251