An interventional study of Digital Monitoring (Active/Passive EMA) and Ecological Momentary Intervention (EMI) via Digital Safety Plan in Depressive Disorder, Major Depressive Disorder, Suicidal Ideation and Suicide, Attempted, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to learn if a multi-layered digital and pharmacogenomic intervention works to prevent suicide re-attempts in adults with depression. It will also evaluate the safety and effectiveness of continuous digital monitoring, digital safety plans, and precision medication management.
The main questions it aims to answer are:
Researchers will compare three groups: participants receiving standard care plus digital monitoring, participants receiving standard care plus digital monitoring and an interactive digital safety plan, and participants receiving standard care plus digital monitoring, a digital safety plan, and pharmacogenetic-guided care.
Participants will:
This is a multi-center, 6-month, 3-arm, parallel-group randomized controlled trial conducted across 10 outpatient psychiatric units in Spain. The study evaluates the integration of active and passive digital phenotyping, an Ecological Momentary Intervention (EMI) via a Digital Safety Plan (DSP), and prospective pharmacogenomics (PGx) and therapeutic drug monitoring (TDM).
Study Design and Interventions:
Participants are randomized in a 1:1:1 ratio to one of three parallel arms:
Data Streams and Biomarker Integration:
The trial incorporates a multimodal data architecture combining active/passive EMA, historical digital trace extraction via Google Takeout (capturing spatiotemporal mobility, search queries, and digital usage footprints), and georeferenced exposomic linkage. Biological samples are collected serially at baseline and follow-up visits (Weeks 4, 8, 12, and 24) for local biochemical safety panels and centralized multi-omics assays-including high-throughput genome-wide association studies (GWAS via Axiom™ Spain Biobank Array), epigenomic methylation profiling, transcriptomics, proteomics, metabolomics, and serum drug quantification.
Statistical and Analytical Plan:
Longitudinal primary and secondary outcomes will be modeled using multilevel hierarchical multivariate regression within an Intention-to-Treat (ITT) framework, incorporating fixed effects for treatment assignment, baseline characteristics, site-level covariates, and time, alongside random effects for individual baseline variability. Genomic associations will be evaluated via mixed logistic regression (SAIGE), gene-set and pathway over-representation analyses (MAGMA/WebGestalt), and Bayesian fine-mapping (susie / coloc) to identify biological targets underlying suicidal behaviour and treatment response.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's planned enrollment of 525 is above the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz is the lead sponsor of 74 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Participants receive standard outpatient psychiatric care (Treatment as Usual; TAU) and install two dedicated smartphone applications (MeMind for active Ecological Momentary Assessment and eB2 Mindcare for passive digital phenotyping) to establish a continuous behavioral baseline. Pharmacogenetic (PGx) and therapeutic drug monitoring (TDM) reports are performed silently and masked from clinicians and participants until trial completion at Week 24
Other: Digital Monitoring (Active/Passive EMA)
Participants receive clinical TAU and active/passive digital monitoring identical to Arm 1. Additionally, they receive a personalised Ecological Momentary Intervention (EMI) consisting of an interactive Digital Safety Plan (DSP) integrated within the MeMind platform. The DSP functions as a Just-In-Time Adaptive Intervention (JITAI), providing real-time coping mechanisms and crisis support pathways triggered manually or via automated crisis detection.
Other: Digital Monitoring (Active/Passive EMA) · Behavioral: Ecological Momentary Intervention (EMI) via Digital Safety Plan
Participants receive clinical TAU, active/passive digital monitoring, and the DSP-based JITAI (identical to Arm 2). In addition, treating clinicians receive prospective, actionable pharmacogenetic (PGx) recommendation reports at longitudinal visits (Weeks 4, 8, 12, and 24) to guide antidepressant selection and dosing, supplemented by liquid chromatography-mass spectrometry (LC-MS) therapeutic drug monitoring (TDM) at Week 8.
Other: Digital Monitoring (Active/Passive EMA) · Behavioral: Ecological Momentary Intervention (EMI) via Digital Safety Plan · Genetic: Pharmacogenetic-Guided Care and Therapeutic Drug Monitoring
Standard outpatient psychiatric care combined with active Ecological Momentary Assessment (EMA via the MeMind app, delivering 2-4 daily push notifications) and passive digital phenotyping (via the eB2 Mindcare app, continuously capturing actigraphy, mobility, and device usage) to track behavioral baselines.
Also known as: MeMind and eB2 Mindcare Monitoring
An automated, interactive Digital Safety Plan (DSP) integrated within the MeMind application, serving as a Just-In-Time Adaptive Intervention (JITAI). It provides real-time coping mechanisms, internal distraction techniques, and emergency contact pathways triggered manually by the patient or automatically via real-time risk detection.
Also known as: Just-In-Time Adaptive Intervention (JITAI), Interactive Digital Safety Plan (DSP)
Prospective pharmacogenetic profiling of CYP2D6 and CYP2C19 loci to provide clinicians with phenotype-guided antidepressant selection and dosing recommendations, supported by liquid chromatography-mass spectrometry (LC-MS) serum therapeutic drug monitoring (TDM) at Week 8.
Also known as: PGx-guided psychopharmacological management, LC-MS Therapeutic Drug Monitoring
Cumulative Incidence Rate of Prospective Non-Fatal Suicide Re-Attempts
The proportion of participants experiencing one or more prospective non-fatal suicide re-attempts over the follow-up period. Event occurrences are ascertained through a combined audit of participants' electronic health records (EHR) and regional emergency department census databases to ensure comprehensive event capture.
Time frame: 24 weeks post-randomisation
Change from Baseline in Depressive Symptom Severity as Measured by the Patient Health Questionnaire-9 (PHQ-9)
Evaluates changes in depressive symptom severity using the PHQ-9 scale, where scores range from 0 to 27, with higher scores indicating greater depression severity. Treatment response is defined as a reduction of 50% or more, and remission as a score of 4 or less.
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
Change from Baseline in Suicidal Ideation Severity Score on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Change in suicidal ideation severity assessed using the C-SSRS clinician-rated scale. The scale evaluates ideation intensity on a ordinal severity subscale ranging from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent).
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
Incidence and Severity of Treatment-Emergent Adverse Drug Reactions (ADRs)
Proportion of participants experiencing one or more treatment-emergent adverse drug reactions (ADRs), recorded via clinician electronic Case Report Form (eCRF) logs, structured patient-reported questionnaires, and standardized nursing UKU Side Effect Rating Scale assessments.
Time frame: 24 weeks post-randomisation
Incremental Cost-Effectiveness Ratio (ICER) Per Averted Suicide Attempt
Health economic evaluation computing the ICER per averted suicide attempt from healthcare system and societal perspectives. Integrates direct medical/non-medical costs and indirect productivity losses using a decision-tree model.
Time frame: 24 weeks post-randomisation
Number of Suicide-Related Emergency Department Visits Per Participant
Total count of emergency department visits specifically attributable to suicidal behavior or acute suicidal crisis per participant, extracted directly from electronic health records.
Time frame: 24 weeks post-randomisation
Number of All-Cause Emergency Department Visits Per Participan
Total count of all-cause emergency department visits per participant, extracted directly from electronic health records.
Time frame: 24 weeks post-randomisation
Number of Psychiatric Hospital Admissions Per Participant
Total count of inpatient psychiatric hospital admissions per participant, extracted directly from electronic health records.
Time frame: 24 weeks post-randomisation
Total Length of Inpatient Psychiatric Stay
Total cumulative number of days spent as an inpatient in a psychiatric hospital setting per participant, extracted directly from electronic health records.
Time frame: 24 weeks post-randomisation
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz