Depressive Disorder, Major Depressive DisorderSMARTomicSNCT07885722
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
A study testing Digital Monitoring (Active/Passive EMA), Ecological Momentary Intervention (EMI) via Digital Safety Plan and Pharmacogenetic-Guided Care and Therapeutic Drug Monitoring in people with Depressive Disorder, Major Depressive Disorder and Suicidal Ideation, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Major Depressive Disorder, Suicidal Ideation, Suicide, Attempted
- What is being tested?
- Digital Monitoring (Active/Passive EMA), Ecological Momentary Intervention (EMI) via Digital Safety Plan and Pharmacogenetic-Guided Care and Therapeutic Drug Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 30 Jun 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Documented history of a suicide attempt within the preceding 2 years
- Current treatable depression indicated by a Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater
- Active possession of an internet-connected smartphone (iOS or Android) with basic digital literacy
- Capacity to provide written informed consent
- Willingness to provide blood samples for genetic, multi-omics, and pharmacokinetic profiling
Who cannot join
- Refusal to install the trial mobile applications (MeMind and eB2 Mindcare)
- Inability to comprehend or sign the informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Instituto Fundación Jiménez Díaz, Madrid, Madrid 28040
Madrid, Madrid, 28040
Chief of the psychiatry department, +34 915 50 48 00 ext. +34, ebaca@fjd.es
Enrique Baca García, Psychiatrist
About this study
Official title: SMARTomicS: Protocol for a Randomised Controlled Trial Evaluating a Multi-layered Digital Phenotyping and Pharmacogenomic Intervention for Suicide 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:
Read more
- Does the multi-layered intervention lower the rate of suicide re-attempts over a 6-month period compared to standard care?
- How do digital tools and genetic-guided prescribing affect depressive symptom severity and treatment-emergent adverse drug reactions?
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:
- Install study smartphone applications (MeMind and eB2 Mindcare) to track daily mood, stress, and activity patterns through active and passive digital phenotyping.
- Authorize historical digital trace extraction via Google Takeout and provide baseline blood samples for genetic, multi-omics, and pharmacokinetic profiling.
- Complete regular clinical checkups and questionnaire assessments at baseline and at weeks 4, 8, 12, and 24.
Read the detailed description
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:
- Arm 1 (Control - TAU + Digital Phenotyping): Receives standard outpatient psychiatric care (TAU) along with active Ecological Momentary Assessment (EMA via MeMind delivering 2-4 daily prompts) and passive digital phenotyping (via eB2 Mindcare tracking actigraphy, mobility, and device usage). Pharmacogenetic and TDM profiling are performed silently, with reports masked and delivered retrospectively at Week 24.
- Arm 2 (Intervention - TAU + Digital Phenotyping + EMI): Receives clinical TAU, active/passive EMA monitoring, and a personalized, interactive Digital Safety Plan (DSP) integrated into the MeMind platform. The DSP acts as a Just-In-Time Adaptive Intervention (JITAI), providing real-time coping strategies and emergency contact pathways that can be user-activated or triggered automatically by algorithmic crisis detection. PGx/TDM reports remain masked until Week 24.
- Arm 3 (Advanced Intervention - TAU + Digital Phenotyping + EMI + Active PGx-Guided Care): Receives clinical TAU, active/passive EMA, and the DSP-based JITAI, combined with active prospective precision clinical decision support. Treating clinicians receive actionable PGx reports at longitudinal visits (Weeks 4, 8, 12, and 24) to guide antidepressant selection and dosing according to national guidelines, supplemented by liquid chromatography-mass spectrometry (LC-MS) therapeutic drug monitoring at Week 8.
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.
- Conditions
- Depressive Disorder, Major Depressive Disorder, Suicidal Ideation, Suicide, Attempted, Suicide Prevention
- Being tested
- Digital Monitoring (Active/Passive EMA), Ecological Momentary Intervention (EMI) via Digital Safety Plan, Pharmacogenetic-Guided Care and Therapeutic Drug Monitoring
- Keywords
- Suicide prevention, Digital phenotyping, Ecological momentary assessment, Ecological momentary intervention, Just-In-Time Adaptive Intervention (JITAI), Pharmacogenomics, Personalized medicine, Major depressive disorder
- Medical subject headings
- Depressive Disorder, Major, Suicidal Ideation, Suicide, Attempted, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Monitoring (Active/Passive EMA)Other
Also called MeMind and eB2 Mindcare 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.
Ecological Momentary Intervention (EMI) via Digital Safety PlanBehavioural
Also called Just-In-Time Adaptive Intervention (JITAI), Interactive Digital Safety Plan (DSP)
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.
Pharmacogenetic-Guided Care and Therapeutic Drug MonitoringGenetic
Also called PGx-guided psychopharmacological management, LC-MS Therapeutic Drug Monitoring
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.
| Study group | Role | What they receive |
|---|---|---|
| TAU + Digital Monitoring | Active comparator | 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 Receives: Other: Digital Monitoring (Active/Passive EMA) |
| TAU + Digital Monitoring + Digital Safety Plan | Experimental | 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. Receives: Other: Digital Monitoring (Active/Passive EMA); Behavioral: Ecological Momentary Intervention (EMI) via Digital Safety Plan |
| TAU + Digital Monitoring + Digital Safety Plan + PGx | Experimental | 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. Receives: Other: Digital Monitoring (Active/Passive EMA); Behavioral: Ecological Momentary Intervention (EMI) via Digital Safety Plan; Genetic: Pharmacogenetic-Guided Care and Therapeutic Drug Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks post-randomisation
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, Major Depressive DisorderStudies 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
- Model description
- This is a 3-arm, parallel-group, randomized controlled trial where participants are allocated in a 1:1:1 ratio to one of three distinct study arms for the duration of the 24-week follow-up period: * Arm 1 (Control): Treatment as Usual (TAU) + active and passive Digital Phenotyping (EMA/passive sensing) with masked pharmacogenetic and therapeutic drug monitoring reports. * Arm 2 (Intervention): TAU + Digital Phenotyping + an interactive Digital Safety Plan (EMI/JITAI). * Arm 3 (Advanced Intervention): TAU + Digital Phenotyping + Digital Safety Plan + active, prospective pharmacogenomic- and therapeutic drug monitoring-guided care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío, Universidad de Oviedo, University of the Balearic Islands, Instituto de Biomedicina (IBiS) de Sevilla, Fundación para la Investigación Biosanitaria del Principado de Asturias, Hospital Clinic of Barcelona, Corporacion Parc Tauli, Hospital Universitario La Paz, Hospital General Universitario Gregorio Marañon, Hospital Universitario Infanta Elena, Hospital Son Espases, Hospital del Mar Research Institute (IMIM), University of Barcelona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885722
- Sponsor's protocol ID
- EC185-24_4H
- Other IDs
- PMP24/00026
- Acronym
- SMARTomicS
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jimenez-Munoz L, Penuelas-Calvo I, Diaz-Olivan I, Gutierrez-Rojas L, Baca-Garcia E, Porras-Segovia A. Suicide Prevention in Your Pocket: A Systematic Review of Ecological Momentary Interventions for the Management of Suicidal Thoughts and Behaviors. Harv Rev Psychiatry. 2022 Mar-Apr 01;30(2):85-99. doi: 10.1097/HRP.0000000000000331.
PubMed 35267251Nuij C, van Ballegooijen W, de Beurs D, Juniar D, Erlangsen A, Portzky G, O'Connor RC, Smit JH, Kerkhof A, Riper H. Safety planning-type interventions for suicide prevention: meta-analysis. Br J Psychiatry. 2021 Aug;219(2):419-426. doi: 10.1192/bjp.2021.50.
PubMed 35048835Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.
PubMed 27663578Bousman CA, Bengesser SA, Aitchison KJ, Amare AT, Aschauer H, Baune BT, Asl BB, Bishop JR, Burmeister M, Chaumette B, Chen LS, Cordner ZA, Deckert J, Degenhardt F, DeLisi LE, Folkersen L, Kennedy JL, Klein TE, McClay JL, McMahon FJ, Musil R, Saccone NL, Sangkuhl K, Stowe RM, Tan EC, Tiwari AK, Zai CC, Zai G, Zhang J, Gaedigk A, Muller DJ. Review and Consensus on Pharmacogenomic Testing in Psychiatry. Pharmacopsychiatry. 2021 Jan;54(1):5-17. doi: 10.1055/a-1288-1061. Epub 2020 Nov 4.
PubMed 33147643Barrigon ML, Romero-Medrano L, Moreno-Munoz P, Porras-Segovia A, Lopez-Castroman J, Courtet P, Artes-Rodriguez A, Baca-Garcia E. One-Week Suicide Risk Prediction Using Real-Time Smartphone Monitoring: Prospective Cohort Study. J Med Internet Res. 2023 Sep 1;25:e43719. doi: 10.2196/43719.
PubMed 37656498
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMARTomicS: Protocol for a Randomised Controlled Trial Evaluating a Multi-layered Digital Phenotyping and Pharmacogenomic Intervention for Suicide Prevention
- ClinicalTrials.gov ID
- NCT07885722
- Acronym / sponsor ID
- SMARTomicS / EC185-24_4H
- Conditions
- Depressive Disorder, Major Depressive Disorder, Suicidal Ideation, Suicide, Attempted, Suicide Prevention
- Keywords
- Suicide prevention, Digital phenotyping, Ecological momentary assessment, Ecological momentary intervention, Just-In-Time Adaptive Intervention (JITAI), Pharmacogenomics, Personalized medicine, Major depressive disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío, Universidad de Oviedo, University of the Balearic Islands, Instituto de Biomedicina (IBiS) de Sevilla, Fundación para la Investigación Biosanitaria del Principado de Asturias, Hospital Clinic of Barcelona, Corporacion Parc Tauli, Hospital Universitario La Paz, Hospital General Universitario Gregorio Marañon, Hospital Universitario Infanta Elena, Hospital Son Espases, Hospital del Mar Research Institute (IMIM), University of Barcelona
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Oct 2026 (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.
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:
- Does the multi-layered intervention lower the rate of suicide re-attempts over a 6-month period compared to standard care?
- How do digital tools and genetic-guided prescribing affect depressive symptom severity and treatment-emergent adverse drug reactions?
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:
- Install study smartphone applications (MeMind and eB2 Mindcare) to track daily mood, stress, and activity patterns through active and passive digital phenotyping.
- Authorize historical digital trace extraction via Google Takeout and provide baseline blood samples for genetic, multi-omics, and pharmacokinetic profiling.
- Complete regular clinical checkups and questionnaire assessments at baseline and at weeks 4, 8, 12, and 24.
Detailed description
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:
- Arm 1 (Control - TAU + Digital Phenotyping): Receives standard outpatient psychiatric care (TAU) along with active Ecological Momentary Assessment (EMA via MeMind delivering 2-4 daily prompts) and passive digital phenotyping (via eB2 Mindcare tracking actigraphy, mobility, and device usage). Pharmacogenetic and TDM profiling are performed silently, with reports masked and delivered retrospectively at Week 24.
- Arm 2 (Intervention - TAU + Digital Phenotyping + EMI): Receives clinical TAU, active/passive EMA monitoring, and a personalized, interactive Digital Safety Plan (DSP) integrated into the MeMind platform. The DSP acts as a Just-In-Time Adaptive Intervention (JITAI), providing real-time coping strategies and emergency contact pathways that can be user-activated or triggered automatically by algorithmic crisis detection. PGx/TDM reports remain masked until Week 24.
- Arm 3 (Advanced Intervention - TAU + Digital Phenotyping + EMI + Active PGx-Guided Care): Receives clinical TAU, active/passive EMA, and the DSP-based JITAI, combined with active prospective precision clinical decision support. Treating clinicians receive actionable PGx reports at longitudinal visits (Weeks 4, 8, 12, and 24) to guide antidepressant selection and dosing according to national guidelines, supplemented by liquid chromatography-mass spectrometry (LC-MS) therapeutic drug monitoring at Week 8.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a 3-arm, parallel-group, randomized controlled trial where participants are allocated in a 1:1:1 ratio to one of three distinct study arms for the duration of the 24-week follow-up period: * Arm 1 (Control): Treatment as Usual (TAU) + active and passive Digital Phenotyping (EMA/passive sensing) with masked pharmacogenetic and therapeutic drug monitoring reports. * Arm 2 (Intervention): TAU + Digital Phenotyping + an interactive Digital Safety Plan (EMI/JITAI). * Arm 3 (Advanced Intervention): TAU + Digital Phenotyping + Digital Safety Plan + active, prospective pharmacogenomic- and therapeutic drug monitoring-guided care.
| Arm | Type | Receives |
|---|---|---|
| TAU + Digital Monitoring | Active comparator | Other: Digital Monitoring (Active/Passive EMA)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 |
| TAU + Digital Monitoring + Digital Safety Plan | Experimental | Other: Digital Monitoring (Active/Passive EMA), Behavioral: Ecological Momentary Intervention (EMI) via Digital Safety PlanParticipants 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. |
| TAU + Digital Monitoring + Digital Safety Plan + PGx | Experimental | Other: Digital Monitoring (Active/Passive EMA), Behavioral: Ecological Momentary Intervention (EMI) via Digital Safety Plan, Genetic: Pharmacogenetic-Guided Care and Therapeutic Drug MonitoringParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older
- Documented history of a suicide attempt within the preceding 2 years
- Current treatable depression indicated by a Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater
- Active possession of an internet-connected smartphone (iOS or Android) with basic digital literacy
- Capacity to provide written informed consent
Key exclusion criteria (2 listed)
- Refusal to install the trial mobile applications (MeMind and eB2 Mindcare)
- Inability to comprehend or sign the informed consent form
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 |
|---|---|---|
| Digital Monitoring (Active/Passive EMA)Also: MeMind and eB2 Mindcare MonitoringStandard 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. | Other | TAU + Digital Monitoring, TAU + Digital Monitoring + Digital Safety Plan, TAU + Digital Monitoring + Digital Safety Plan + PGx |
| Ecological Momentary Intervention (EMI) via Digital Safety PlanAlso: Just-In-Time Adaptive Intervention (JITAI), Interactive Digital Safety Plan (DSP)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. | Behavioural | TAU + Digital Monitoring + Digital Safety Plan, TAU + Digital Monitoring + Digital Safety Plan + PGx |
| Pharmacogenetic-Guided Care and Therapeutic Drug MonitoringAlso: PGx-guided psychopharmacological management, LC-MS Therapeutic Drug MonitoringProspective 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. | Genetic | TAU + Digital Monitoring + Digital Safety Plan + PGx |
Primary outcome
Cumulative Incidence Rate of Prospective Non-Fatal Suicide Re-Attempts
Time frame: 24 weeks post-randomisation
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.
8 secondary outcomes
Change from Baseline in Depressive Symptom Severity as Measured by the Patient Health Questionnaire-9 (PHQ-9)
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)
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
Incidence and Severity of Treatment-Emergent Adverse Drug Reactions (ADRs)
Time frame: 24 weeks post-randomisation
Incremental Cost-Effectiveness Ratio (ICER) Per Averted Suicide Attempt
Time frame: 24 weeks post-randomisation
Number of Suicide-Related Emergency Department Visits Per Participant
Time frame: 24 weeks post-randomisation
Number of All-Cause Emergency Department Visits Per Participan
Time frame: 24 weeks post-randomisation
Number of Psychiatric Hospital Admissions Per Participant
Time frame: 24 weeks post-randomisation
Total Length of Inpatient Psychiatric Stay
Time frame: 24 weeks post-randomisation
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 21 Oct 2026.
- Background: PubMed 35267251Jimenez-Munoz L, Penuelas-Calvo I, Diaz-Olivan I, Gutierrez-Rojas L, Baca-Garcia E, Porras-Segovia A. Suicide Prevention in Your Pocket: A Systematic Review of Ecological Momentary Interventions for the Management of Suicidal Thoughts and Behaviors. Harv Rev Psychiatry. 2022 Mar-Apr 01;30(2):85-99. doi: 10.1097/HRP.0000000000000331.
- Background: PubMed 35048835Nuij C, van Ballegooijen W, de Beurs D, Juniar D, Erlangsen A, Portzky G, O'Connor RC, Smit JH, Kerkhof A, Riper H. Safety planning-type interventions for suicide prevention: meta-analysis. Br J Psychiatry. 2021 Aug;219(2):419-426. doi: 10.1192/bjp.2021.50.
- Background: PubMed 27663578Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.
- Background: PubMed 33147643Bousman CA, Bengesser SA, Aitchison KJ, Amare AT, Aschauer H, Baune BT, Asl BB, Bishop JR, Burmeister M, Chaumette B, Chen LS, Cordner ZA, Deckert J, Degenhardt F, DeLisi LE, Folkersen L, Kennedy JL, Klein TE, McClay JL, McMahon FJ, Musil R, Saccone NL, Sangkuhl K, Stowe RM, Tan EC, Tiwari AK, Zai CC, Zai G, Zhang J, Gaedigk A, Muller DJ. Review and Consensus on Pharmacogenomic Testing in Psychiatry. Pharmacopsychiatry. 2021 Jan;54(1):5-17. doi: 10.1055/a-1288-1061. Epub 2020 Nov 4.
- Background: PubMed 37656498Barrigon ML, Romero-Medrano L, Moreno-Munoz P, Porras-Segovia A, Lopez-Castroman J, Courtet P, Artes-Rodriguez A, Baca-Garcia E. One-Week Suicide Risk Prediction Using Real-Time Smartphone Monitoring: Prospective Cohort Study. J Med Internet Res. 2023 Sep 1;25:e43719. doi: 10.2196/43719.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Monitoring (Active/Passive EMA), Ecological Momentary Intervention (EMI) via Digital Safety Plan and Pharmacogenetic-Guided Care and Therapeutic Drug Monitoring in people with Depressive Disorder, Major Depressive Disorder and Suicidal Ideation, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Enrique Baca Garcia, Psychiatrist (+34 626932936 ext. +34, ebaca@fjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence Rate of Prospective Non-Fatal Suicide Re-Attempts (time frame: 24 weeks post-randomisation). 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 NCT07885722, which also lists 5 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 21 Oct 2026.