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

NCT06556251 | Recruiting DMC

• 1 other identifier: PIC_37_23
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Device Adherence

Keywords

platform; technologies; young people; early psychosis; adherence

Outcome Measures

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.

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

Secondary Outcomes (12)

• Direct costs use services

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

• Penetration of the platform

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

• Indirect costs

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

• Scale of the Impact of Perceived Symptoms in Schizophrenia

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

• Medication Adherence Scale-8 items

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

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental group (EG) will have access to the PIPPEP platform in addition to treatment in the Early Psychosis Programme.

Device: PIPPEP App

Treatment as Usual

ACTIVE COMPARATOR

The control group (CG) will receive treatment as usual (TAU) without using the platform.

Device: PIPPEP App

Interventions

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).

Experimental Group; Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Parc Sanitari Sant Joan de Déu: collaborator

Study Sites (1)

Parc Sanitari Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, 08830, Spain

RECRUITING

Related Publications (12)

• 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.

  PMID: 26454555 BACKGROUND

• 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.

  PMID: 25934413 BACKGROUND

• Marshall M, Rathbone J. Early intervention for psychosis. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD004718. doi: 10.1002/14651858.CD004718.pub3.

  PMID: 21678345 BACKGROUND

• 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.

  PMID: 25946398 BACKGROUND

• 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.

  PMID: 17099591 BACKGROUND

• 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.

  PMID: 16865042 BACKGROUND

• 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.

  PMID: 29720785 BACKGROUND

• 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.

  PMID: 27489456 BACKGROUND

• 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.

  PMID: 28684386 BACKGROUND

• 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.

  PMID: 27053003 BACKGROUND

• 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.

  PMID: 26011657 BACKGROUND

• 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.

  PMID: 28729235 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

MARIA TRINIDAD PELÁEZ MARTÍNEZ

CONTACT

0034 670 971 773; mtrinidad.pelaez@sjd.es

ALICIA COLOMER SALVANS

CONTACT

0034 93 640 63 50; alicia.colomer@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: August 15, 2024
• Study Start: September 18, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 25, 2025

Record last verified: 2024-12

Locations

ES (1)