Device AdherenceNCT06556251
Effectiveness of a Digital Platform in Engagement and Prognosis of Patients in an Early Intervention Pychosis Programme
A study testing PIPPEP App in people with Device Adherence, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Device Adherence
- What is being tested?
- PIPPEP App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 18 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, 08830
MARIA TRINIDAD PELÁEZ MARTÍNEZ, 0034 679537185, mtrinidad.pelaez@sjd.es
ALICIA COLOMER SALVANS, 0034 6406350, alicia.colomer@sjd.es
About this study
Official title: Evaluating the Effectiveness of a Digital Platform in the Engagement and Prognosis of Patients in the Early Intervention Programme in Psychosis
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:
Read more
- 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.
Read the 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.
- Conditions
- Device Adherence
- Being tested
- PIPPEP App
- Keywords
- platform, technologies, young people, early psychosis, adherence
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPPEP AppDevice
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 group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental group (EG) will have access to the PIPPEP platform in addition to treatment in the Early Psychosis Programme. Receives: Device: PIPPEP App |
| Treatment as Usual | Active comparator | The control group (CG) will receive treatment as usual (TAU) without using the platform. Receives: Device: PIPPEP App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- does not turn up for scheduled visits and does not report in.
- cannot be reached by telephone.
- 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.
Measured: Baseline, 6 months follow-up, 12 months follow-up
Secondary outcomes (12)
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).
Measured: Baseline, 6 months follow-up, 12 months follow-up
Penetration of the platform
Penetration of the platform (e.g. number of accesses to the platform, number of consultations with professionals).
Measured: Baseline, 6 months follow-up, 12 months follow-up
Indirect costs
Indirect costs (e.g. temporary inability to work, permanent disabilities, premature mortality (completed suicide, accident, other medical causes).
Measured: Baseline, 6 months follow-up, 12 months follow-up
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.
Measured: Baseline, 6 months follow-up, 12 months follow-up
Medication Adherence Scale-8 items
It is a 8 items is a structured, self-administered measure of medication adherence behaviour. It consists of 8 items and asks the person to answer yes or no to questions about medication adherence. Total scores are categorized as low (MMAS-8 score <6), medium (MMAS-8 score 6 to <8), and high (MMAS-8 score 8). Lower scores indicate worse adherence.
Measured: Baseline, 6 months follow-up, 12 months follow-up
Scale for side effects of medication (UKU)
This scale evaluates psychological, neurological, autonomic and other side effects of the medication. At the end there is a general assessment of the impairment that these effects may have on the patient's daily activities.It comprises ratings (0-4) of 48 single items, the higher the score, the greater the presence and severity of side effects.
Measured: Baseline, 6 months follow-up, 12 months follow-up
The Beck Cognitive Insight Scale for Schizophrenia (BCIS)
It is a self-administered scale that measures cognitive insight capacity, i.e., self-reflection as a metacognitive mechanism for analysing the symptoms of the illness that allows for continuous re-evaluation of inappropriate interpretations. A composite index, Cognitive Insight, is calculated as Reflectiveness minus Certainty (CI=R-C). The response format includes four Likert-type options: Never Agree (0), Somewhat Agree (1), Quite Agree (2) and Totally Agree (3), with a total score between 0 and 45. Higher scores on self-reflection and the composite index indicate greater cognitive insight, while lower scores on self-confidence indicate better cognitive insight.
Measured: Baseline, 6 months follow-up, 12 months follow-up
Questionnaire on the consumption of toxic substances
Ad hoc checklist asking to indicate whether the person has consumed any of the following substances in the last 3 months: Caffeine or theine, tobacco, alcohol, cannabis, cocaine, amphetamines, opiates, hallucinogens, designer drugs, stimulants, benzodiazepines, inhalants or other drugs. The participant will be also asked to indicate the quantity and frequency of use.
Measured: Baseline, 6 months follow-up, 12 months follow-up
Questionnaire on anxiety and depression
It consists of two ad hoc questions in which the person is asked a) to what extent they have felt nervous and/or stressed in the last week and b) to what extent they have felt sad and/or depressed. The person must answer on a scale from 0 to 5: "never", "almost never", "occasionally", "often" or "very often". The higher the score, the greater the presence and severity of the side effects
Measured: Baseline, 6 months follow-up, 12 months follow-up
Scale for self-perception of social stigmatisation (SSQ)
This is a self-administered scale with a number of statements relating to the respondent's views on mental illness and their own experiences. It is required that the level is chosen according to the statements presented, on a scale of 1 to 7 (1 = Strongly agree, 2 = moderately agree, 3 = slightly agree, 4 = neither agree nor disagree, 5 = slightly disagree, 6 = moderately disagree, and 7 = strongly disagree). Higher scores indicate lower self-stigma.
Measured: Baseline, 6 months follow-up, 12 months follow-up
Quality of life. Quality of Life Index (QLI-sp)
This is a 10-item questionnaire covering the following dimensions: psychological well-being, physical well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, emotional and social support, community support and services, self-actualisation or personal fulfilment, spiritual satisfaction and global quality of life assessment. Each item is rated by the respondent according to their personal and cultural view of this concept on a Likert scale from 0 to 10 points. The higher the score, the higher the respondent's quality of life.
Measured: Baseline, 6 months follow-up, 12 months follow-up
Global Assessment of Functioning (GAF) scale
It is an heteroadministered scale that assesses the patient's functioning (including psychological, social and occupational activities) over the last 12 months on a scale between 0 and 100. Higher scores indicate higer level of functioning.
Measured: Baseline, 6 months follow-up, 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start18 Sep 2024
- Primary completion15 Sep 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Device AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Parc Sanitari Sant Joan de Déu
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556251
- Sponsor's protocol ID
- PIC_37_23
- Status last verified
- Dec 2024
- First submitted
- 2 Jul 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26454555Lloyd-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.
PubMed 25934413Marshall M, Rathbone J. Early intervention for psychosis. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD004718. doi: 10.1002/14651858.CD004718.pub3.
PubMed 21678345Leclerc 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.
PubMed 25946398Bonsack 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.
PubMed 17099591Schimmelmann 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.
PubMed 16865042Berry 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.
PubMed 29720785Arean 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.
PubMed 27489456Torous 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.
PubMed 28684386Gay 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.
PubMed 27053003Abdel-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.
PubMed 26011657Killikelly 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.
PubMed 28729235
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Digital Platform in the Engagement and Prognosis of Patients in the Early Intervention Programme in Psychosis
- ClinicalTrials.gov ID
- NCT06556251
- Acronym / sponsor ID
- PIC_37_23
- Conditions
- Device Adherence
- Keywords
- platform, technologies, young people, early psychosis, adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Parc Sanitari Sant Joan de Déu
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: PIPPEP AppExperimental group (EG) will have access to the PIPPEP platform in addition to treatment in the Early Psychosis Programme. |
| Treatment as Usual | Active comparator | Device: PIPPEP AppThe control group (CG) will receive treatment as usual (TAU) without using the platform. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIPPEP AppDigital 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). | Device | Experimental Group, Treatment as Usual |
Primary outcome
Adherence to psychosocial treatment.
Time frame: 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.
12 secondary outcomes
Direct costs use services
Time frame: Baseline, 6 months follow-up, 12 months follow-up
Penetration of the platform
Time frame: Baseline, 6 months follow-up, 12 months follow-up
Indirect costs
Time frame: Baseline, 6 months follow-up, 12 months follow-up
Scale of the Impact of Perceived Symptoms in Schizophrenia
Time frame: Baseline, 6 months follow-up, 12 months follow-up
Medication Adherence Scale-8 items
Time frame: Baseline, 6 months follow-up, 12 months follow-up
Scale for side effects of medication (UKU)
Time frame: Baseline, 6 months follow-up, 12 months follow-up
The Beck Cognitive Insight Scale for Schizophrenia (BCIS)
Time frame: Baseline, 6 months follow-up, 12 months follow-up
Questionnaire on the consumption of toxic substances
Time frame: Baseline, 6 months follow-up, 12 months follow-up
Questionnaire on anxiety and depression
Time frame: Baseline, 6 months follow-up, 12 months follow-up
Scale for self-perception of social stigmatisation (SSQ)
Time frame: Baseline, 6 months follow-up, 12 months follow-up
Quality of life. Quality of Life Index (QLI-sp)
Time frame: Baseline, 6 months follow-up, 12 months follow-up
Global Assessment of Functioning (GAF) scale
Time frame: Baseline, 6 months follow-up, 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Results publication: PubMed 26454555Lal 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.
- Results publication: PubMed 25934413Lloyd-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.
- Results publication: PubMed 21678345Marshall M, Rathbone J. Early intervention for psychosis. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD004718. doi: 10.1002/14651858.CD004718.pub3.
- Results publication: PubMed 25946398Leclerc 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.
- Results publication: PubMed 17099591Bonsack 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.
- Results publication: PubMed 16865042Schimmelmann 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.
- Results publication: PubMed 29720785Berry 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.
- Results publication: PubMed 27489456Arean 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.
- Results publication: PubMed 28684386Torous 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.
- Results publication: PubMed 27053003Gay 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.
- Results publication: PubMed 26011657Abdel-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.
- Results publication: PubMed 28729235Killikelly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIPPEP App in people with Device Adherence, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MARIA TRINIDAD PELÁEZ MARTÍNEZ (0034 670 971 773, mtrinidad.pelaez@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to psychosocial treatment. (time frame: Baseline, 6 months follow-up, 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06556251, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.