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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorFundació Sant Joan de Déu

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • PIPPEP App

    Device

    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).

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Treatment as UsualActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adherence to psychosocial treatment.

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.

Time frame
Baseline, 6 months follow-up, 12 months follow-up

Secondary outcomes

1

Direct costs use services

Direct costs related to the use of services (e.g. scheduled primary care visits, urgent General Practitioner visits,tests (TAC, Magnetic Resonance, Analytical).

Time frame
Baseline, 6 months follow-up, 12 months follow-up
2

Penetration of the platform

Penetration of the platform (e.g. number of accesses to the platform, number of consultations with professionals).

Time frame
Baseline, 6 months follow-up, 12 months follow-up
3

Indirect costs

Indirect costs (e.g. temporary inability to work, permanent disabilities, premature mortality (completed suicide, accident, other medical causes).

Time frame
Baseline, 6 months follow-up, 12 months follow-up
4

Scale of the Impact of Perceived Symptoms in Schizophrenia

This is a self-administered scale that measures psychotic symptoms and the impact of symptoms on the patient's daily life.

Time frame
Baseline, 6 months follow-up, 12 months follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundació Sant Joan de Déu

Lead sponsor

Parc Sanitari Sant Joan de Déu

Collaborator