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Development, Feasibility and Effectiveness of a Digital Support Platform for Mental Health in Primary Care (PRESTO).

NCT04559360 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2021-09-13

No results posted yet for this study

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: 1.a periodic follow-up, 2.symptoms monitoring and brief psychological intervention with a smartphone app, or 3.a 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 centres(PCC) 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 2.0 detailed afterwards:

Conditions

  • Depression, Anxiety

Interventions

DEVICE

PRESTOapp

The intervention group will be asked to use the app for a period of 2 months.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-02-28
Completion
2022-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04559360 on ClinicalTrials.gov