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

Condition(s) studied

Investigational drug(s) / intervention(s)

PIPPEP 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).

Study 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

Primary outcome measure(s)

• Adherence to psychosocial treatment. — Baseline, 6 months follow-up, 12 months follow-up
  Attendance at follow-up appointments with the therapeutic team. Lack of engagement or lack of adherence will be assumed if the patient remains uninterrupted for a period of at least one month despite the need for treatment: 1. does not turn up for scheduled visits and does not report in. 2. cannot be reached by telephone. 3. actively refuses contact with professionals and/or treatment. If one of the above conditions is met, the person's last contact is considered the date of drop-out.

Trial sites (1)

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