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
Brief Summary

Objective: To design, develop, and evaluate a personalized intervention for the universalprevention 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-monthfollow-up. The entire process of recruitment, random allocation, intervention, andfollow-up will be conducted through the 'PredictPlusPrevent' platform and its associatedapps. Following a media campaign, at least 9,000 Spanish participants aged 18 to 55 yearswithout depression and/or anxiety at baseline will be randomly assigned to theintervention or active control group "PredictPlusPrevent". The "PredictPlusPrevent"intervention will be self-guided and implemented through participants' smartphones via anapp; it will have a biopsychosocial and multi-component approach (8 modules: physicalexercise, improving sleep, expanding relationships, problem-solving, improvingcommunication, assertiveness, decision-making, and managing thoughts). The"PredictPlusPrevent" intervention is based on validated risk algorithms for depressionand anxiety and a DSS that will help participants develop their own personalizeddepression prevention plans, which they will implement themselves while the platformmonitors and provides feedback. The active control "PredictPlusPrevent" will includeinformation from the risk algorithms and 24 self-help booklets. The primary outcome willbe the incidence of new cases of depression and/or anxiety assessed using the PRIME-MDquestionnaire, and secondary outcomes will include reductions in depression (PHQ-9) andanxiety symptoms (GAD-7), probability of depression and anxiety risk (predictD andpredictA algorithms), and physical and mental quality of life (SF-12).

Detailed Description

Not Provided

Not yet recruiting
Depression
Anxiety Disorders

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.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 55 Years
Locations

Not Provided

Contacts

Juan Á. Bellón, PhD
+34951030534
jabellon@uma.es

Not Provided

The Mediterranean Institute for the Advance of Biotechnology and Health Research
NCT Number
Keywords
depression
Anxiety disorders
prevention
M-health
App
randomized controlled trial
MeSH Terms
Depression
Depressive Disorder
Anxiety Disorders