Clinical trial NCT06556251: Effectiveness of a Digital Platform in Engagement and Prognosis of Patients in an Early Intervention Pychosis Programme
Official title: Evaluating the Effectiveness of a Digital Platform in the Engagement and Prognosis of Patients in the Early Intervention Programme in Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Device Adherence
Keywords: platform
technologies
young people
early psychosis
adherence
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Parc Sanitari Sant Joan de Déu
First posted: 2024-08-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a randomised, prospective and single-centre clinical trial in which one group (EG) will have access to the PIPPEP platform in addition TAU, while the other group (CG) will receive TAU without using the platform.

The study will be carried out in all 9 community mental health centres of the Sanitary Parc Sant Joan de Déu. Patients will be randomly assigned to the EG or CG using a list of random numbers. The evaluation will be based on variables of the clinical history of the patients in both conditions (EG and CG) at the beginning of the study, after 6 months and after 12 months.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Background:

Mental disorders are the most common cause of disability in young people, with the disconnect with mental health in adolescents being as high as 50% in some cases. Much research has been conducted on psychotic disorders in recent decades, particularly on their early clinical manifestations. This has led to the establishment of numerous psychosis detection and early intervention programmes around the world to initiate treatment as early as possible.

This situation emphasises the need to change the model of mental health care and focus on the adolescent population in particular with preventive, diagnostic and therapeutic interventions. To improve patient engagement, the importance of a good therapeutic alliance, patient voluntarism, a collaborative approach and clear and continuous communication between patients and professionals was emphasised.

Online and mobile interventions have been shown to be acceptable and effective in improving individuals' self-care practises across a wide range of healthcare settings. They have enabled the implementation of evidence-based interventions to promote healthy behaviours (smoking cessation, physical activity, anxiety, depression...) and reduce barriers to accessing mental health services, and have also been shown to be feasible, acceptable and effective for a wide range of mental health conditions. Ease of use, accessibility and potentially reduced stigmatisation are cited as benefits. They also have the potential to reduce healthcare costs and offer options to aid diagnosis, facilitate real-time assessment and monitoring of symptoms, and provide innovative treatments for a variety of conditions. Adherence rates for these interventions are high, ranging from 60-100% (average 83%). A recent Canadian study conducted with a sample of young people treated in an early intervention team concluded that the use of the internet and various technological devices by young people with a first episode of psychosis is similar to that of young people in the general population of the same age.

Procedure:

This study will be a randomised, prospective and single-centre clinical trial in which one group (EG) will have access to the PIPPEP platform in addition to treatment in the PIPPEP, while the other group (CG) will receiveTAU without using the platform.

A second part of the study will consist of a quasi-experimental longitudinal study of a single group (EG) in which the data from the questionnaires submitted via the platform will be analysed. The data from the questionnaires will be transferred to and stored in each participant's medical record, with all the security measures that apply to all patient data.

These questionnaires will appear in a notification format on the participant's device and will be completed at the beginning of the study, after 6 months and after 12 months, with the exception of the anxiety and depression questionnaire, which will be completed weekly.

Interventions:

The PIPPEP is a care programme that includes patients with a first psychotic episode (FEP), with a UHR or within the first 5 years of illness development (critical period). It is a multidisciplinary intervention involving psychiatric, nursing, social work and psychological visits using evidence-based psychotherapy (cognitive-behavioural). The maximum duration of the intervention is 5 years.

Patients belonging to the EG will additionally have access to the PIPPEP platform, while patients assigned to the CG will continue to receive TAU. The platform will have the basic functionalities already present in the PIPPEP application (requesting reports, visits or tests) and will also include the following content:

* Specific information about psychotic and comorbid symptoms, substance use, available treatments, healthy lifestyle habits, knowledge of emergency social and health resources, and outpatient clinics for youth. The psychoeducational content will include links that redirect to the SOM 360 (Mental Health webpage) (specifically the psychosis website) for more in-depth information.
* Additional questionnaires that will be self-completed at regular intervals to allow the clinical team to monitor symptoms, emotional state, side effects, etc. The information obtained through these questionnaires is transmitted directly and stored in each patient's medical history, with all the associated security measures.
* A bi-directional messaging service with the referral team to allow better accessibility for non-urgent aspects.
* A reward system to encourage use of the application with points, rewards and mini-games.
* A folder where patients can keep documents they find useful, such as the relapse prevention plan and the crisis plan.

In addition, during the personalised follow-up sessions that are part of the TAU, patients assigned to the EG will receive support in using the application from the PIPPEP therapists.

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.

Primary outcomes:
measure: Adherence to psychosocial treatment.
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
Secondary outcomes:
measure: Direct costs use services
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
measure: Penetration of the platform
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
measure: Indirect costs
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
measure: Scale of the Impact of Perceived Symptoms in Schizophrenia
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
measure: Medication Adherence Scale-8 items
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
measure: Scale for side effects of medication (UKU)
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
measure: The Beck Cognitive Insight Scale for Schizophrenia (BCIS)
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
measure: Questionnaire on the consumption of toxic substances
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
measure: Questionnaire on anxiety and depression
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
measure: Scale for self-perception of social stigmatisation (SSQ)
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
measure: Quality of life. Quality of Life Index (QLI-sp)
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
measure: Global Assessment of Functioning (GAF) scale
timeFrame: Baseline, 6 months follow-up, 12 months follow-up
Other outcomes:
Locations:
city: Sant Boi de Llobregat
country: Spain
facility: Parc Sanitari Sant Joan de Déu
state: Barcelona
Study officials:
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