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

NCT04559360 | Unknown DMC

• 1 other identifier: PI046549
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

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: 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

Keywords

PRESTO; smartphone; application; primary care; anxiety; depression

Outcome Measures

Primary Outcomes (2)

• The 9-items Patient Health Questionnaire (PHQ-9)

  Change in symptoms measured by The 9-items Patient Health Questionnaire (PHQ-9) Values ranging from 0 to 27

  2 months

• The 7-item Generalized Anxiety Disorder Questionnaire (GAD-7)

  Change in symptoms measured by The 7-item Generalized Anxiety Disorder Questionnaire (GAD-7) Values ranging from 0 to 21

  2 months

Secondary Outcomes (2)

• The World Health Organization 5-item General Welfare Index (WHO-5)

  2 months

• The Holmes and Rahe Stress Scale

  2 months

Study Arms (2)

Active group - PRESTOapp users

ACTIVE COMPARATOR

Once users are recruited, an independent researcher will randomize the participants using a 1:1 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 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.

Device: PRESTOapp

Control group

NO INTERVENTION

The control group will receive the usual follow-up and treatment during the same time by the PCMHSP team.

Interventions

PRESTOapp DEVICE

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

Active group - PRESTOapp users

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Individuals who do not know and/or do not wish to learn the skills required to operate a smartphone.
• Estimated IQ less than 70 with functional impairment Patients with 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)

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Related Publications (1)

• Anmella G, Prime-Tous M, Segu X, Solanes A, Ruiz V, Martin-Villalba I, Morilla I, Also-Fontanet A, Sant E, Murgui S, Sans-Corrales M, Murru A, Zahn R, Young AH, Vicens V, Vinas-Bardolet C, Martinez-Cerda JF, Blanch J, Radua J, Fullana MA, Cavero M, Vieta E, Hidalgo-Mazzei D. PRimary carE digital Support ToOl in mental health (PRESTO): Design, development and study protocols. Span J Psychiatry Ment Health. 2024 Apr-Jun;17(2):114-125. doi: 10.1016/j.rpsm.2021.04.003. Epub 2021 Apr 29.

  PMID: 33933665 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor, Psychiatrist, PhD

Model Details: Single-blind randomized controlled clinical trial.

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 22, 2020
• Study Start: December 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 13, 2021

Record last verified: 2021-09