Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
SMARTomicS
SMARTomicS: Protocol for a Randomised Controlled Trial Evaluating a Multi-layered Digital Phenotyping and Pharmacogenomic Intervention for Suicide Prevention
2 other identifiers
interventional
525
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2025
CompletedFirst Submitted
Initial submission to the registry
September 24, 2026
CompletedFirst Posted
Study publicly available on registry
October 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
October 21, 2026
October 1, 2026
1.8 years
September 24, 2026
October 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
24 weeks post-randomisation
Secondary Outcomes (8)
Change from Baseline in Depressive Symptom Severity as Measured by the Patient Health Questionnaire-9 (PHQ-9)
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)
Baseline, Week 4, Week 8, Week 12, and Week 24
Incidence and Severity of Treatment-Emergent Adverse Drug Reactions (ADRs)
24 weeks post-randomisation
Incremental Cost-Effectiveness Ratio (ICER) Per Averted Suicide Attempt
24 weeks post-randomisation
Number of Suicide-Related Emergency Department Visits Per Participant
24 weeks post-randomisation
- +3 more secondary outcomes
Study Arms (3)
TAU + Digital Monitoring
ACTIVE COMPARATORParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Refusal to install the trial mobile applications (MeMind and eB2 Mindcare)
- Inability to comprehend or sign the informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díazlead
- Hospitales Universitarios Virgen del Rocíocollaborator
- Universidad de Oviedocollaborator
- Universidad de las Islas Balearescollaborator
- Instituto de Biomedicina (IBiS) de Sevillacollaborator
- Fundación para la Investigación Biosanitaria del Principado de Asturiascollaborator
- Hospital Clinic of Barcelonacollaborator
- Corporacion Parc Taulicollaborator
- Hospital Universitario La Pazcollaborator
- Hospital General Universitario Gregorio Marañoncollaborator
- Hospital Universitario Infanta Elenacollaborator
- Hospital Son Espasescollaborator
- Hospital del Mar Research Institute (IMIM)collaborator
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain.collaborator
Study Sites (1)
Instituto Fundación Jiménez Díaz, Madrid, Madrid 28040
Madrid, Madrid, 28040, Spain
Related Publications (5)
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.
PMID: 35267251BACKGROUNDNuij 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.
PMID: 35048835BACKGROUNDNahum-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.
PMID: 27663578BACKGROUNDBousman 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.
PMID: 33147643BACKGROUNDBarrigon 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.
PMID: 37656498BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Due to the active nature of the digital health interventions (EMA/EMI) and real-time pharmacogenomic feedback, participants, care providers, and treating investigators are unblinded (open-label). However, outcome assessors evaluating secondary clinical endpoints and electronic health records remain blinded to study-arm allocation.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2026
First Posted
October 21, 2026
Study Start
September 1, 2025
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
October 21, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will not share