Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556251
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
Effectiveness of a Digital Platform in Engagement and Prognosis of Patients in an Early Intervention Pychosis Programme
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Effectiveness of a Digital Platform in the Engagement and Prognosis of Patients in the Early Intervention Programme in Psychosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 participants medical record with all the security measures that apply to all patient data
These questionnaires will appear in a notification format on the participants 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 patients 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
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 participants medical record with all the security measures that apply to all patient data
These questionnaires will appear in a notification format on the participants 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None