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DepressionNCT03990792

Personalized Prevention of Depression in Primary Care

A study testing e-predictD intervention and Brief psychoeducational intervention in people with Depression, run by The Mediterranean Institute for the Advance of Biotechnology and Health Research at 6 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main goal is to design, develop and evaluate a personalized intervention to prevent the onset of depression based on Information and Communications Technology (ICTs), risk predictive algorithms and decision support systems (DSS) for patients and general practitioners (GPs). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Depression
What is being tested?
e-predictD intervention and Brief psychoeducational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
663 participants
Where
6 sitesSpain
Study dates
1 Feb 2020to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult

Who may be able to join

  • PHQ-9 <10 at baseline
  • Moderate-high risk of depression (predictD risk algorithm score ≥ 10%)

Who cannot join

  • Not have a smartphone and internet for personal use
  • Unable to speak Spanish
  • Documented terminal illness
  • Documented cognitive impairment
  • Limiting sensory disorder (e.g. deafness)
  • Documented serious mental illness (psychosis, bipolar, addictions, etc.)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Spain6 sites

  • Juan M. Mendive

    Barcelona

  • María Isabel Ballesta Rodríguez

    Jaén

  • Antonina Rodríguez Bayón

    Linares

  • Juan Á Bellón

    Málaga

  • Emiliano Rodríguez

    Salamanca

  • Yolanda López del Hoyo

    Zaragoza

Other trials in Spain

About this study

Official title: Preventing the Onset of Depression Through a Personalized Intervention Based on ICTs, Risk Prediction Algorithms and Decision Support Systems for Patients and GPs: the e-predictD Study

The main goal is to design, develop and evaluate a personalized intervention to prevent the onset of depression based on Information and Communications Technology (ICTs), risk predictive algorithms and decision support systems (DSS) for patients and general practitioners (GPs). The specific goals are 1) to design and develop a DSS, called e-predictD-DSS, to elaborate personalized plans to prevent depression; 2) to design and develop an ICT solution that integrates the DSS on the web, a mobile application (App), the risk predictive algorithm, different intervention modules and a monitoring-feedback system; 3) to evaluate the usability and adherence of primary care patients and their GPs with the e-predictD intervention; 4) to evaluate the effectiveness of the e-predictD intervention to reduce the incidence of major depression, depression and anxiety symptoms and the probability of major depression next year; 5) to evaluate the cost-effectiveness and cost-utility of the e-predictD intervention to prevent depression.

Methods: This is a randomized controlled trial with allocation by cluster (GPs), simple blind, two parallel arms (e-predictD vs "active m-Health control") and 1 year follow-up including 720 patients (360 in each arm) and 72 GPs (36 in each arm). Patients will be free of major depression at baseline and aged between 18 and 55 years old. Primary outcome will be the incidence of major depression at 12 months measured by CIDI. As secondary outcomes: depressive and anxiety symptomatology measured by PHQ-9 and GAD-7 and the risk probability of depression measured by predictD algorithm, as well as cost-effectiveness and cost-utility. The e-predictD intervention is multi-component and it is based on a DSS that helps the patients to elaborate their own personalized depression prevention plans, which the patient approves, and implements, and the system monitors offering feedback to the patient and to the GPs. It is an e-Health intervention because it is based on a web and m-Health because it is also implemented on the patient's smartphones through an App. In addition, it integrates a risk algorithm of depression, which is already validated (the predictD algorithm). It also includes an initial GP-patient interview and a specific training for the GP. Finally, a map of potentially useful local community resources to prevent depression will be integrated into the DSS.

Conditions
Depression
Being tested
e-predictD intervention, Brief psychoeducational intervention
Keywords
Depression, Primary Prevention, Primary Health Care, Randomized controlled trial, mHealth, App
Medical subject headings
Depression, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-predictD interventionBehavioural

    The intervention is based on validated risk algorithms to predict depression and includes: 1) Mobile applications as main user's interface; 2) a DSS that helps patients to develop their own personalized plans to prevent (PPP) depression; 3) eight intervention modules (the core of the system) including activities to prevent depression, to be proposed by the DSS and chosen by the patient. 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. Patients will implement the recommendations and the tool will monitor these actions, offering feedback to improve their PPP at 3, 6 and 9 months. The intervention also includes an initial and single 15-minute face-to-face GP-patient interview.

  • Brief psychoeducational interventionOther

    The intervention consists of an App that weekly send brief psychoeducational messages about physical and mental health (depression, anxiety, sleep hygiene, physical activity, etc.)

Study groups in NCT03990792
Study groupRoleWhat they receive
e-predictD interventionExperimentalIn this arm, patients will receive a personalized intervention to prevent depression based on ICTs, risk predictive algorithms and decision support systems (DSS) for patients and General Practitioners (GPs).
Receives: Behavioral: e-predictD intervention
m-Health controlActive comparatorIn this arm, patients will continue receiving the usual care from their GPs. In addition, they will use an App with the same appearance as the e-predictD App but it will only send weekly messages about physical and mental health management. This intervention is not personalized and does not include GP training and GP-patient interview.
Receives: Other: Brief psychoeducational intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of major depression measured by the Composite International Diagnostic Interview (CIDI)

    Composite International Diagnostic Interview (CIDI) is a structured diagnostic interview that provides current diagnoses of major depression

    Measured: 12 months

Secondary outcomes (4)

  1. 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 scale range is 0 to 27 (9 items)

    Measured: 12 months

  2. 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

  3. Probability of depression (predictD risk algorithm)

    Measured: 12 months

  4. Cost-effectiveness and cost-utility

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2019
  2. Study start1 Feb 2020
  3. Primary completion31 Aug 2023
  4. Study completion31 Dec 2023

Resources

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
663 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03990792
Sponsor's protocol ID
PI15/00401
Status last verified
May 2025
First submitted
17 Jun 2019
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Moreno-Peral P, Campos-Paino H, Rodriguez-Morejon A, Conejo-Ceron S, Rodriguez-Bayon A, Ballesta-Rodriguez MI, Rodriguez-Sanchez E, Mendive JM, Lopez Del Hoyo Y, Luna JD, Tamayo O, Bellon JA. Toward personalized interventions for preventing depression in primary care: Qualitative and quantitative findings from the e-predictD pilot study. PLoS One. 2026 Sep 11;21(9):e0355675. doi: 10.1371/journal.pone.0355675. eCollection 2026.

    PubMed 42726702

  • Bellon JA, Rodriguez-Morejon A, Conejo-Ceron S, Campos-Paino H, Rodriguez-Bayon A, Ballesta-Rodriguez MI, Rodriguez-Sanchez E, Mendive JM, Lopez Del Hoyo Y, Luna JD, Tamayo-Morales O, Moreno-Peral P. A personalized intervention to prevent depression in primary care based on risk predictive algorithms and decision support systems: protocol of the e-predictD study. Front Psychiatry. 2023 Jun 2;14:1163800. doi: 10.3389/fpsyt.2023.1163800. eCollection 2023.

    PubMed 37333911

Questions about this trial

What is this clinical trial studying?

A study testing e-predictD intervention and Brief psychoeducational intervention in people with Depression, run by The Mediterranean Institute for the Advance of Biotechnology and Health Research at 6 sites in Spain.

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 6 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: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of major depression measured by the Composite International Diagnostic Interview (CIDI) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03990792, which also lists 2 linked publications.

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 28 May 2025.

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