Clinical trial NCT06351800: The PredictPlusPrevent Study
Official title: Universal Prevention of Depression and Anxiety in the General Population Through a Personalized Intervention Based on Risk Algorithms, ICTs, and Decision Support Systems: Randomized Controlled Trial. The "PredictPlusPrevent" Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Anxiety Disorders
Keywords: Depression
Anxiety Disorders
Prevention
m-health
App
Randomized Controlled Trial
Lead sponsor: The Mediterranean Institute for the Advance of Biotechnology and Health Research
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 9000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of depression and/or anxiety disorders.
timeFrame: 12 months
Secondary outcomes:
measure: Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9).
timeFrame: 12 months
measure: Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7).
timeFrame: 12 months
measure: Probability of depression measured by the Spanish predictD risk algorithm.
timeFrame: 12 months
measure: Probability of anxiety measured by the Spanish predictA risk algorithm.
timeFrame: 12 months
measure: Quality of life measured by the 12-item Short Form (SF-12).
timeFrame: 12 months
Other outcomes:
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