Sleep and Appetite Measures as Suicidal Risk Factors in a French- Spanish Cohort of Suicidal Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,044
- 试验地点
- 4
- 主要终点
- Occurrence of suicidal event assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
Sleep and appetite disorders as well as social exclusion, have been linked to the emergence of suicidal ideation (SI) and suicide attempts.This study aims to evaluate the relationship between those factors and suicidal ideation and behaviour. To assess those factors an ecological momentary assessment (EMA) desing will be used.
EMA will be carried out using 2 applications integrated into the smartphone of participants (Android or iOS), one to make an explicit data collection with questions and another one for the implicit collection of data from mobile sensors.
1044 suicide attempters will be included in three sites and followed for 6 months. Participants will be evaluated at inclusion and at the end of follow-up. The hypothesis is that sleep, appetite and social exclusion factors collected with the smartphone application will be linked to the intensity of death wish, suicidal ideations and suicidal attempts.
An auxiliary study will also be led with 300 patients carrying an actimeter for the 30 first days after inclusion. This will help collecting more accurate data on various sleep parameters.
详细描述
The proposed study will use ecological momentary assessment (EMA) via smartphone applications (apps) and wearable trackers to examine the relationship between suicidality (wish to die, suicidal ideation and suicide attempt) and changes in sleep quality and disturbed appetite. These behavioral markers, if the hypothesis is proven true, could help predict increased suicidal risk in real-time within a vulnerable population across different cultures.
The study aims to: (1) Establish the extent to which quality of sleep is related to suicide ideation and suicide attempts; (2) Establish the extent to which change in appetite is related to suicide ideation and suicide attempts; (3) Determine the emotional impact of the app when suicidality is assessed; (4) Clarify the timeline of the relationship between sleep disturbances and suicidal behavior; (5) Develop personalized algorithms based on EMA protocol and motor activity markers or "signatures" to assess the risk of suicide attempts.
The hypothesis is that variations in sleep quality will correlate with increased wish to die, suicide ideation and suicide attempts. It is expected that a decrease in sleep quality will be a suicide risk marker especially among young individuals.
This prospective cross-national study will use the infrastructure of an existing network (WORECA). Woreca has defined a common protocol of suicide assessment, data sharing and analysis strategy.
1044 suicide attempters will be included and followed for 6 months. Each participant will be assessed using an EMA protocol via two smartphone apps: (1) One app will ask everyday questions following a dynamic protocol to assess quality of sleep, appetite, suicidal ideation and psychopathology; (2) the other app will record activity using smartphone sensors. Additionally, 300 participants (150 in France and 150 in Spain) will have their sleep phases and other physiological changes during sleep monitored with a wearable armband. Study outcomes include wish to live, wish to die, suicidal ideation, and suicide attempt during the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be at least 18 years old
- •To use a smartphone as a personal phone
- •To have consulted in the context of a suicidal crisis within the last 7 days
- •To be able to understand the nature, purpose and methodoly of the study.
- •To be in a minimal treatment phase (according to the clinician's judgment).
- •To accept participating to the study and the 6 months follow-up and to have signed the informed consent
排除标准
- •Refusal of participation
- •Subject protected by law (guardianship)
- •Deprived of liberty Subject (by judicial or administrative decision)
- •Diagnosis of a current hypomanic, manic or mixed episode, or a diagnosis of schizoaffective disorder or schizophrenia.
- •No affiliation to the social safety system
- •Exclusion period in relation to another protocol
- •65 years old patients and older with an MMSE score < 24 at baseline
结局指标
主要结局
Occurrence of suicidal event assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: 6 months
Evaluate the occurrence of a suicidal event with the C-SSRS. The questionnaire includes four subscales. The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
次要结局
- Evaluation of appetite assessed by ecological momentary assessment (EMA)(6 months)
- Evaluation of sensibility to social exclusion assessed by ecological momentary assessment (EMA)(6 months)
- Evaluation of suicide attempts severity assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)(6 months)
- Evaluation of insomnia assessed by ecological momentary assessment (EMA)(6 months)
- Evaluation of insomnia assessed by Insomnia Severity Index (ISI)(6 months)
- Evaluation of suicidal ideation intensity assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)(6 months)
- Evaluation of the intensity of death wish assessed by ecological momentary assessment (EMA)(6 months)
- Evaluation of physical activity by eB2(6 months)
- Evaluation of sleep duration assessed by Pittsburgh Sleep Quality Index (PSQI)(6 months)