DepressionNCT06351800
The PredictPlusPrevent Study
A study testing Predictplusprevent intervention and Psychoeducational intervention in people with Depression and Anxiety Disorders, run by The Mediterranean Institute for the Advance of Biotechnology and Health Research.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety Disorders
- What is being tested?
- Predictplusprevent intervention and Psychoeducational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 7 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 55 years.
- Participants must have a smartphone for their own use in the next year.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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
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
- Being tested
- Predictplusprevent intervention, Psychoeducational intervention
- Keywords
- Depression, Anxiety Disorders, Prevention, m-health, App, Randomized Controlled Trial
- Medical subject headings
- Depression, Anxiety Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predictplusprevent interventionBehavioural
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.
Psychoeducational interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Psychoeducational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9).
The Patient Health Questionnaire-9 (PHQ-9) measures symptoms of depression through 9 items, each of which is scored 0 ('not at all') to 3 ('nearly every day'). Low scores are equivalent to less symptoms of depression, the scalen range is 0 to 27 (9 items).
Measured: 12 months
Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7).
The General Anxiety Questionnaire (GAD-7) measures generalized anxiety disorder through 7 items, each of which is scored 0 ('not at all') to 3 ('nearly every day'). Low scores are equivalent to less symptoms of anxiety, the scale range is 0 to 21 (7 items).
Measured: 12 months
Probability of depression measured by the Spanish predictD risk algorithm.
The Spanish predictD risk algorithm measures 13 risk factors for depression.
Measured: 12 months
Probability of anxiety measured by the Spanish predictA risk algorithm.
The Spanish predictA risk algorithm measures 12 risk factors for anxiety disorders.
Measured: 12 months
Quality of life measured by the 12-item Short Form (SF-12).
The 12-item Short Form (SF-12) measures quality of life related to physical health and quality of life related to mental health. Scores on the scales range from 0 to 100. Higher scores are equivalent to better health-related quality of life.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start15 Feb 2026 (estimated)
- Primary completion7 Mar 2028 (estimated)
- Study completion7 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Mediterranean Institute for the Advance of Biotechnology and Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Ángel Bellón, The Mediterranean Institute for the Advance of Biotechnology and Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351800
- Sponsor's protocol ID
- PE-0280-2018
- Status last verified
- Sep 2025
- First submitted
- 25 Mar 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06351800
- Acronym / sponsor ID
- PE-0280-2018
- Conditions
- Depression, Anxiety Disorders
- Keywords
- Depression, Anxiety Disorders, Prevention, m-health, App, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- The Mediterranean Institute for the Advance of Biotechnology and Health ResearchUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 7 Mar 2028 (estimated)
- Study completion
- 7 Mar 2028 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Predictplusprevent intervention | Experimental | Behavioral: Predictplusprevent interventionThe 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. |
| Active control group | Active comparator | Other: Psychoeducational interventionThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 and 55 years.
- Participants must have a smartphone for their own use in the next year.
Key exclusion criteria (5 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predictplusprevent interventionThe 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. | Behavioural | Predictplusprevent intervention |
| Psychoeducational interventionTo 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. | Other | Active control group |
Primary outcome
Incidence of depression and/or anxiety disorders.
Time frame: 12 months
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.
5 secondary outcomes
Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9).
Time frame: 12 months
Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7).
Time frame: 12 months
Probability of depression measured by the Spanish predictD risk algorithm.
Time frame: 12 months
Probability of anxiety measured by the Spanish predictA risk algorithm.
Time frame: 12 months
Quality of life measured by the 12-item Short Form (SF-12).
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Predictplusprevent intervention and Psychoeducational intervention in people with Depression and Anxiety Disorders, run by The Mediterranean Institute for the Advance of Biotechnology and Health Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Á. Bellón, PhD (+34951030534, jabellon@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of depression and/or anxiety disorders. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.