The PredictPlusPrevent Study

NCT06351800 | Not Yet Recruiting DMC

• 1 other identifier: PE-0280-2018
• Study Type: interventional
• Target: 9,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Depression; Anxiety Disorders; Prevention; m-health; App; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Incidence of depression and/or anxiety disorders.

  Incidence of depression and/or anxiety disorders by Primary Care Evaluation of Mental Disorders (PRIME-MD). PRIME-MD is a diagnostic tool to diagnose depression and anxiety disorders.

  12 months

Secondary Outcomes (5)

• Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9).

  12 months

• Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7).

  12 months

• Probability of depression measured by the Spanish predictD risk algorithm.

  12 months

• Probability of anxiety measured by the Spanish predictA risk algorithm.

  12 months

• Quality of life measured by the 12-item Short Form (SF-12).

  12 months

Study Arms (2)

Predictplusprevent intervention

EXPERIMENTAL

The intervention will provide information about the likelihood of experiencing depression and anxiety. Additionally, it will offer a personalized depression prevention plan (PPP) based on various interventions such as physical exercise, sleep, expanding relationships, problem-solving, improving communication, assertiveness, decision-making, and managing thoughts.

Behavioral: Predictplusprevent intervention

Active control group

ACTIVE COMPARATOR

The intervention in the active control group will involve assessing the risk level of experiencing depression and/or anxiety in the next 12 months every 3 months. Additionally, participants assigned to this intervention will have free access to the 24 self-help booklets for preventing depression and anxiety included in the 'predictplusprevent' web platform. However, this group will not receive personalized prevention plans, decision support systems, or monitoring and feedback. They will also not have access to the 8 self-guided and interactive modules used in the intervention group.

Other: Psychoeducational intervention

Interventions

Predictplusprevent intervention BEHAVIORAL

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.

Predictplusprevent intervention

Psychoeducational intervention OTHER

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.

Active control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 55 years.
• Participants must have a smartphone for their own use in the next year.

You may not qualify if:

• Not signing the informed consent.
• Having depression and/or anxiety at baseline according to the PRIME-MD questionnaire.
• Living outside of Spain.
• Having a severe mental disorder (psychosis, bipolar disorder, addictions, etc.), a terminal illness or cognitive impairment (dementia).
• Difficulties in understanding Spanish.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Depression; Anxiety Disorders; Alzheimer Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Central Study Contacts

Juan Á. Bellón, PhD

CONTACT

+34951030534; jabellon@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 8, 2024
• Study Start: February 15, 2026
• Primary Completion (Estimated): March 7, 2028
• Study Completion (Estimated): March 7, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09