The PredictPlusPrevent Study

Summary

Objective: To design, develop, and evaluate a personalized intervention for the universal prevention of depression and anxiety in the general population based on risk algorithms, ICTs, and decision support systems (DSS).

Methods: A double-blind, parallel-group, randomized controlled trial with a twelve-month follow-up. The entire process of recruitment, random allocation, intervention, and follow-up will be conducted through the 'PredictPlusPrevent' platform and its associated apps. Following a media campaign, at least 9,000 Spanish participants aged 18 to 55 years without depression and/or anxiety at baseline will be randomly assigned to the intervention or active control group "PredictPlusPrevent". The "PredictPlusPrevent" intervention will be self-guided and implemented through participants' smartphones via an app; it will have a biopsychosocial and multi-component approach (8 modules: physical exercise, improving sleep, expanding relationships, problem-solving, improving communication, assertiveness, decision-making, and managing thoughts). The "PredictPlusPrevent" intervention is based on validated risk algorithms for depression and anxiety and a DSS that will help participants develop their own personalized depression prevention plans, which they will implement themselves while the platform monitors and provides feedback. The active control "PredictPlusPrevent" will include information from the risk algorithms and 24 self-help booklets. The primary outcome will be the incidence of new cases of depression and/or anxiety assessed using the PRIME-MD questionnaire, and secondary outcomes will include reductions in depression (PHQ-9) and anxiety symptoms (GAD-7), probability of depression and anxiety risk (predictD and predictA algorithms), and physical and mental quality of life (SF-12).

Conditions

• Depression
• Anxiety Disorders

Interventions

BEHAVIORAL

Predictplusprevent intervention

The intervention is based on validated risk algorithms to predict depression and anxiety and includes: 1) Mobile applications as main user's interface; 2) a DSS that helps participants to develop their own personalized plans to prevent (PPP) depression and/or anxiety; 3) eight intervention modules (the core of the system) including activities to prevent depression and anxiety, to be proposed and monitoring by the DSS. The intervention is biopsychosocial and multi-component, including the following modules: physical exercise, improving sleep, expanding relationships, problem solving, improving communication skills, assertiveness training, making decisions and managing thoughts. Participants will implement the recommendations and the tool will monitor these actions, offering feedback to improve their PPP at 3, 6, 9 and 12 months.

OTHER

Psychoeducational intervention

To know the level of risk of experiencing depression and/or anxiety in the next 12 months. In addition, participants assigned to this intervention will have free access to the 24 self-help pamphlets for preventing depression and anxiety.

Sponsors & Collaborators

• The Mediterranean Institute for the Advance of Biotechnology and Health Research

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-15

Primary Completion

2028-03-07

Completion

2028-03-07