Prevention of Suicidal Behavior Through Therapeutic Interventions Guided by Digital Phenotype and Pharmacogenetics: The SMARTomicS Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Suicide attempt
研究概览
简要总结
The goal of this protocol for an observational retrospective multi-site cohort study is to develop a predictive algorithm for suicidal behavior integrating genetic risk markers, digital phenotypes, and exposomic data in people with a lifetime history of suicide attempt. Participants will be aged from 12 onwards (requiring parental consent if under 18) and only be excluded if they are unable to provide a genetic sample or do not consent to the study. The main question[s] it aims to answer is:
- Can genotyping/omics analysis of individuals with a history of suicidal behaviuor reveal potential genetic factors associated with suicide risk?
Secondary questions include:
- Can behavioral factors associated with suicide risk be explored through data obtained from Google Takeout?
- Is there an association between medication changes and suicidal behavior, as identified through the Unified Prescription Module and the Digital Health Record?
- Do different suicidal phenotypes differ based on the collected variables?
- Can the investigators construct an exposome using geolocated and time-stamped data from Google Takeout, combined anonymously with data from the National Statistics and Meteorology Institutes?
The investigators hypothesize that:
- Individuals with a history of suicidal behavior will show significant genotypic differences compared to the general population (based on Spanish Genome Project data).
- Suicidal phenotypes-especially between single and multiple attempters-will differ across collected variables, including genotype, omics, and exposome data.
participants will complete genetic assessments, digital phenotypes, clinical questionnaires and exposomic data
详细描述
Participant recruitment will occur in person at outpatient mental health clinics, emergency departments, and short-stay hospital units. Mental health professionals (psychiatrists, psychologists, and nurses) will assess eligibility during clinical encounters, provide study information, and obtain informed consent. Data will be entered into the MeMind environment for data monitoring, and patient validation, ensuring eligibility criteria and noting any missing information.
Prior to recruitment, training sessions and standardized guidelines are provided to healthcare professionals to ensure adherence to the study protocol.
Data will be verified against INE statistics and hospital records to assess the representativeness and completeness of the data.
The primary outcome is suicidal behavior risk, assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS), the Brugha scale, documented suicidal events, healthcare utilization, behavioral patterns, digital phenotyping, and pharmacological treatment modifications. Secondary outcomes include evaluating the efficacy of pharmacological treatments and the cost-effectiveness of genetic markers in guiding antidepressant selection.
Baseline data collection includes:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one suicide attempt in their lifetime.
- •The attempt must have occurred when the participant was older than 12 years old.
- •Participants must be at least 18 years old or have parental consent if aged 12-17.
排除标准
- •medical contraindication prevents blood sample collection
- •unable to provide informed consent to participate in the study
研究组 & 干预措施
Group 1
Our only group consists of people with a lifetime history of suicide attempt
干预措施: No Intervention: Observational Cohort (Genetic)
结局指标
主要结局
Suicide attempt
时间窗: Baseline assessment; lifetime suicide attempts occurring from age 12 until enrollment.
Aim to explore associated factors to suicide attempt
次要结局
- pharmacological treatment efficacy(Assessed at baseline; retrospective evaluation of pharmacological treatments received prior to enrollment.)
- cost-effectiveness of genetic markers(Baseline assessment)