Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04559360
Status:
UNKNOWN
Last Update Posted:
2021-09-13
First Post:
2020-09-10
Brief Title:
Development Feasibility and Effectiveness of a Digital Support Platform for Mental Health in Primary Care PRESTO
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Development Feasibility and Effectiveness of a Digital Support Platform for Mental Health in Primary Care PRESTO Based on a Machine Learning Approach
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRESTO
Brief Summary:
The prevalence of mental health disorders in Primary Care PC largely exceeds the limited resources available The main aim of this project is to develop a comprehensive machine learning ML digital support platform PRESTO to approach people with mental health symptoms in PC PRESTO will offer a transdiagnostic triage of those cases needing specialized care while most of the mild and moderate cases with anxiety and depressive symptoms will be allocated through ML models to either 1a periodic follow-up 2symptoms monitoring and brief psychological intervention with a smartphone app or 3a specific psychopharmacological treatment To reach this objective first a ML predictive severity model will be build based on all the cases referred to the PC mental health support programme during the last 5 years retrieved from electronic health records from 5 PC centresPCC in Barcelona Simultaneously a smartphone app PRESTOapp monitoring symptoms and delivering a psychological intervention for non-severe anxious and depressive symptomatology will be developed and tested in a feasibility study and in a randomized clinical trial Finally the ML models obtained from the first phase of the project and the data from the PRESTOapp study will be integrated in a comprehensive self-learning web platform which will triage and assign to each case a specific intervention based on the predicted outcome The effectiveness of PRESTO to reduce waiting times in receiving appropriate and specific care of mental health problems will be tested by means of a stepped-wedge randomized controlled trial in 5 PCCs in Barcelona
Here we register a Randomized controlled clinical trial with PRESTOapp 20 detailed afterwards
Here we register a Randomized controlled clinical trial with PRESTOapp 20 detailed afterwards
Detailed Description:
The prevalence of mental health disorders in Primary Care PC largely exceeds the limited resources available The main aim of this project is to develop a comprehensive machine learning ML digital support platform PRESTO to approach people with mental health symptoms in PC PRESTO will offer a transdiagnostic triage of those cases needing specialized care while most of the mild and moderate cases with anxiety and depressive symptoms will be allocated through ML models to either 1a periodic follow-up 2symptoms monitoring and brief psychological intervention with a smartphone app or 3a specific psychopharmacological treatment To reach this objective first a ML predictive severity model will be build based on all the cases referred to the PC mental health support programme during the last 5 years retrieved from electronic health records from 5 PC centresPCC in Barcelona Simultaneously a smartphone app PRESTOapp monitoring symptoms and delivering a psychological intervention for non-severe anxious and depressive symptomatology will be developed and tested in a feasibility study and in a randomized clinical trial Finally the ML models obtained from the first phase of the project and the data from the PRESTOapp study will be integrated in a comprehensive self-learning web platform which will triage and assign to each case a specific intervention based on the predicted outcome The effectiveness of PRESTO to reduce waiting times in receiving appropriate and specific care of mental health problems will be tested by means of a stepped-wedge randomized controlled trial in 5 PCCs in Barcelona
Here we register a Randomized controlled clinical trial with PRESTOapp 20
Design Single-blind randomized controlled clinical trial
Sample Referrals to mental health support programme PCMHSP by GPs from the 5 primary care centres included in the study
Sample size calculation Considering the priority primary outcome the reduction of depressive symptoms assessed by PHQ-9 and taking into account two groups PRESTOapp 20 vs treatment as usual in addition to previous results of effect sizes between 030 - 035 from similar studies similar intervention same scale we have established a power of 080 and a α of 005 Considering the current numbers of visits by all members of the PCMHSP who can potentially be offered inclusion in the study in 6 months 1000 individuals the total sample should have at least 122 participants However experience in similar studies indicates an expected 25-30 drop-out Therefore it was decided to add 15 more subjects per branch for preventive purposes and to ensure that at the end of the study there would be a sufficient sample to guarantee the strength of the data
Intervention Group PRESTOapp 20 76 participants
Control Group Treatment as usual 76 participants TOTAL 152 participants
Considering the number of PCMHSP members involved in the project as well as the high number of referrals which is the main problem this project is trying to solve reaching these numbers is fully feasible within the stipulated time
Inclusion criteria Individuals 18-65 years of age who are referred to or are being followed up by members of the PCMHSP in the 5 PCCs corresponding to the 5 Barcelona catchment areas ABS scoring between 4 and 14 points on the PHQ-9 scale or 6 to 15 on the GAD-7 scale They must also accept and sign the informed consent for study participation and must have a compatible smartphone Android or iPhone
Exclusion criteria Individuals who do not know andor do not wish to learn the skills required to operate a smartphone Estimated IQ less than 70 with functional impairment Patients with a severe mental disorder Bipolar Disorder Schizophrenic Disorder Schizoaffective Obsessive-Compulsive or substance use disorder PHQ-9 15 GAD-7 16 People with moderate to severe suicidal ideation PHQ-9 Question 9 with a score of 2 or 3
Recruitment procedure All users referred to PCMHSPs by GPs from the PCC included in the study will be offered participation in the study Once the information on the study has been provided which will also be available in printed form in the waiting room for consultations any doubts presented by the user will be cleared up and the signature of the informed consent will be requested
Randomization Once users are recruited an independent researcher will randomize the participants using a 11 sequential method in two groups of 76 individuals and will assign a 6-digit identification code IC to each participant The IC will be given to the participant on a reminder card and will be used to access the app to guaranteeing its confidentiality The name of the subjects and their respective code will be stored in independent servers for methodological security and legal reasons The intervention group will be asked to use the app for a period of 2 months The control group will receive the usual follow-up and treatment during the same time by the PCMHSP team
Data collection
Initial evaluation The estimated time used for the initial evaluation including an explanation of the study signing of the informed consent and data collection is of about 30 minutes
Intervention Group In this first visit a brief explanation of how the app works and a brochure explaining PRESTOapp 20 will be given Users will be asked to use the app on their smartphone for the next 2 months During this first visit we will help the participant to install the app Subsequently the following data will be collected
Demographic variables gender age marital status housing condition number of children years of education educational level employment status
Clinical variables medical comorbidities hospitalizations number of depressive episodes and previous hospitalizations history of psychotic symptoms seasonal pattern history of melancholy atypical psychotic or catatonic symptoms in depressive episodes comorbidity axes I II and III family history first degree of psychiatric disorders and suicide number of self-initiated attempts and method
Care variables Number of visits in MAP in the last 5 years number of visits in PSP number of consultations in the emergency department The 9-items Patient Health Questionnaire PHQ-9
The 7-item Generalized Anxiety Disorder Questionnaire GAD-7
World Health Organization 5-item General Welfare Index WHO-5
Holmes and Rahe Stress Scale
Participants will be informed that the next follow-up visit and clinical assessment by the PCMHSP will be in 2 months at the end of the study unless the app indicates or symptoms that require urgent care arise
Control Group The same information and scales as for the intervention group will be collected
Follow-up evaluation A follow-up appointment will be carried out in both groups after 2 months lasting approximately 30 minutes during which the same data collected in the baseline interview will be collected in addition to the Technology Acceptance Model TAM usability with the System usability scale SUS and satisfaction with the Health App Usability Questionnaire MAUQ
Statistical analysis All the data will be collected by the project researchers and the PCMHSP team and stored in encrypted and secure servers The data from the app will be managed by the researchers only Statistical analyses will be conducted using specific R packages The analyses of all the subjects included will be considered until the abandonment or end of the study The main variable is the change in symptoms measured by PHQ-9 GAD-7 secondarily it will be considered WHO-5 during the 2 months controlled by life stressors as assessed by the Holmes y Rahe scale We will use a mixed effects linear model with random interception for each participant The differences in the primary measures will be analyzed first in an unadjusted manner and then adjusted for sociodemographic and clinical factors collected if you present a p01 in univariate analysis An analysis by intention to treat ITT with last observation carried performed LOCF will also be employed A threshold of statistical significance p005 two-tailed will be set
Study limitations There is no investigator blinded for logistical and ethical reasons nor is there a placebo in the case of controls The main reason for this design is that the methodological effects of providing a placebo app to the control group are unclear Assumable risks are the placebo effect in the intervention group natural progression and regression to the mean
Here we register a Randomized controlled clinical trial with PRESTOapp 20
Design Single-blind randomized controlled clinical trial
Sample Referrals to mental health support programme PCMHSP by GPs from the 5 primary care centres included in the study
Sample size calculation Considering the priority primary outcome the reduction of depressive symptoms assessed by PHQ-9 and taking into account two groups PRESTOapp 20 vs treatment as usual in addition to previous results of effect sizes between 030 - 035 from similar studies similar intervention same scale we have established a power of 080 and a α of 005 Considering the current numbers of visits by all members of the PCMHSP who can potentially be offered inclusion in the study in 6 months 1000 individuals the total sample should have at least 122 participants However experience in similar studies indicates an expected 25-30 drop-out Therefore it was decided to add 15 more subjects per branch for preventive purposes and to ensure that at the end of the study there would be a sufficient sample to guarantee the strength of the data
Intervention Group PRESTOapp 20 76 participants
Control Group Treatment as usual 76 participants TOTAL 152 participants
Considering the number of PCMHSP members involved in the project as well as the high number of referrals which is the main problem this project is trying to solve reaching these numbers is fully feasible within the stipulated time
Inclusion criteria Individuals 18-65 years of age who are referred to or are being followed up by members of the PCMHSP in the 5 PCCs corresponding to the 5 Barcelona catchment areas ABS scoring between 4 and 14 points on the PHQ-9 scale or 6 to 15 on the GAD-7 scale They must also accept and sign the informed consent for study participation and must have a compatible smartphone Android or iPhone
Exclusion criteria Individuals who do not know andor do not wish to learn the skills required to operate a smartphone Estimated IQ less than 70 with functional impairment Patients with a severe mental disorder Bipolar Disorder Schizophrenic Disorder Schizoaffective Obsessive-Compulsive or substance use disorder PHQ-9 15 GAD-7 16 People with moderate to severe suicidal ideation PHQ-9 Question 9 with a score of 2 or 3
Recruitment procedure All users referred to PCMHSPs by GPs from the PCC included in the study will be offered participation in the study Once the information on the study has been provided which will also be available in printed form in the waiting room for consultations any doubts presented by the user will be cleared up and the signature of the informed consent will be requested
Randomization Once users are recruited an independent researcher will randomize the participants using a 11 sequential method in two groups of 76 individuals and will assign a 6-digit identification code IC to each participant The IC will be given to the participant on a reminder card and will be used to access the app to guaranteeing its confidentiality The name of the subjects and their respective code will be stored in independent servers for methodological security and legal reasons The intervention group will be asked to use the app for a period of 2 months The control group will receive the usual follow-up and treatment during the same time by the PCMHSP team
Data collection
Initial evaluation The estimated time used for the initial evaluation including an explanation of the study signing of the informed consent and data collection is of about 30 minutes
Intervention Group In this first visit a brief explanation of how the app works and a brochure explaining PRESTOapp 20 will be given Users will be asked to use the app on their smartphone for the next 2 months During this first visit we will help the participant to install the app Subsequently the following data will be collected
Demographic variables gender age marital status housing condition number of children years of education educational level employment status
Clinical variables medical comorbidities hospitalizations number of depressive episodes and previous hospitalizations history of psychotic symptoms seasonal pattern history of melancholy atypical psychotic or catatonic symptoms in depressive episodes comorbidity axes I II and III family history first degree of psychiatric disorders and suicide number of self-initiated attempts and method
Care variables Number of visits in MAP in the last 5 years number of visits in PSP number of consultations in the emergency department The 9-items Patient Health Questionnaire PHQ-9
The 7-item Generalized Anxiety Disorder Questionnaire GAD-7
World Health Organization 5-item General Welfare Index WHO-5
Holmes and Rahe Stress Scale
Participants will be informed that the next follow-up visit and clinical assessment by the PCMHSP will be in 2 months at the end of the study unless the app indicates or symptoms that require urgent care arise
Control Group The same information and scales as for the intervention group will be collected
Follow-up evaluation A follow-up appointment will be carried out in both groups after 2 months lasting approximately 30 minutes during which the same data collected in the baseline interview will be collected in addition to the Technology Acceptance Model TAM usability with the System usability scale SUS and satisfaction with the Health App Usability Questionnaire MAUQ
Statistical analysis All the data will be collected by the project researchers and the PCMHSP team and stored in encrypted and secure servers The data from the app will be managed by the researchers only Statistical analyses will be conducted using specific R packages The analyses of all the subjects included will be considered until the abandonment or end of the study The main variable is the change in symptoms measured by PHQ-9 GAD-7 secondarily it will be considered WHO-5 during the 2 months controlled by life stressors as assessed by the Holmes y Rahe scale We will use a mixed effects linear model with random interception for each participant The differences in the primary measures will be analyzed first in an unadjusted manner and then adjusted for sociodemographic and clinical factors collected if you present a p01 in univariate analysis An analysis by intention to treat ITT with last observation carried performed LOCF will also be employed A threshold of statistical significance p005 two-tailed will be set
Study limitations There is no investigator blinded for logistical and ethical reasons nor is there a placebo in the case of controls The main reason for this design is that the methodological effects of providing a placebo app to the control group are unclear Assumable risks are the placebo effect in the intervention group natural progression and regression to the mean
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None