Effectiveness of a Digital Platform in Engagement and Prognosis of Patients in an Early Intervention Pychosis Programme
NCT ID: NCT06556251
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
128 participants
INTERVENTIONAL
2024-09-18
2027-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental Group
Experimental group (EG) will have access to the PIPPEP platform in addition to treatment in the Early Psychosis Programme.
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).
Treatment as Usual
The control group (CG) will receive treatment as usual (TAU) without using the platform.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
40 Years
ALL
No
Sponsors
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Parc Sanitari Sant Joan de Déu
OTHER
Fundació Sant Joan de Déu
OTHER
Responsible Party
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Locations
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Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Lal S, Malla A. Service Engagement in First-Episode Psychosis: Current Issues and Future Directions. Can J Psychiatry. 2015 Aug;60(8):341-5. doi: 10.1177/070674371506000802.
Lloyd-Evans B, Sweeney A, Hinton M, Morant N, Pilling S, Leibowitz J, Killaspy H, Tanskanen S, Totman J, Armstrong J, Johnson S. Evaluation of a community awareness programme to reduce delays in referrals to early intervention services and enhance early detection of psychosis. BMC Psychiatry. 2015 May 2;15:98. doi: 10.1186/s12888-015-0485-y.
Marshall M, Rathbone J. Early intervention for psychosis. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD004718. doi: 10.1002/14651858.CD004718.pub3.
Leclerc E, Noto C, Bressan RA, Brietzke E. Determinants of adherence to treatment in first-episode psychosis: a comprehensive review. Braz J Psychiatry. 2015 Apr-Jun;37(2):168-76. doi: 10.1590/1516-4446-2014-1539. Epub 2015 May 1.
Bonsack C, Pfister T, Conus P. [Linkage to care after first hospitalisation for psychosis]. Encephale. 2006 Oct;32(5 Pt 1):679-85. doi: 10.1016/s0013-7006(06)76219-4. French.
Schimmelmann BG, Conus P, Schacht M, McGORRY P, Lambert M. Predictors of service disengagement in first-admitted adolescents with psychosis. J Am Acad Child Adolesc Psychiatry. 2006 Aug;45(8):990-999. doi: 10.1097/01.chi.0000223015.29530.65.
Berry D, Blair C, Willoughby M, Garrett-Peters P, Vernon-Feagans L, Mills-Koonce WR; Family Life Project Key Investigators. Household Chaos and Children's Cognitive and Socio-Emotional Development in Early Childhood: Does Childcare Play a Buffering Role? Early Child Res Q. 2016 1st Quarter;34:115-127. doi: 10.1016/j.ecresq.2015.09.003. Epub 2015 Oct 31.
Arean PA, Hoa Ly K, Andersson G. Mobile technology for mental health assessment. Dialogues Clin Neurosci. 2016 Jun;18(2):163-9. doi: 10.31887/DCNS.2016.18.2/parean.
Torous J, Roux S. Patient-Driven Innovation for Mobile Mental Health Technology: Case Report of Symptom Tracking in Schizophrenia. JMIR Ment Health. 2017 Jul 6;4(3):e27. doi: 10.2196/mental.7911.
Gay C, Chabaud A, Guilley E, Coudeyre E. Educating patients about the benefits of physical activity and exercise for their hip and knee osteoarthritis. Systematic literature review. Ann Phys Rehabil Med. 2016 Jun;59(3):174-183. doi: 10.1016/j.rehab.2016.02.005. Epub 2016 Apr 1.
Abdel-Baki A, Lal S, D-Charron O, Stip E, Kara N. Understanding access and use of technology among youth with first-episode psychosis to inform the development of technology-enabled therapeutic interventions. Early Interv Psychiatry. 2017 Feb;11(1):72-76. doi: 10.1111/eip.12250. Epub 2015 May 22.
Killikelly C, He Z, Reeder C, Wykes T. Improving Adherence to Web-Based and Mobile Technologies for People With Psychosis: Systematic Review of New Potential Predictors of Adherence. JMIR Mhealth Uhealth. 2017 Jul 20;5(7):e94. doi: 10.2196/mhealth.7088.
Other Identifiers
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PIC_37_23
Identifier Type: -
Identifier Source: org_study_id
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