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Идёт набор NCT07554729

AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN (THE SURVIVE 2 STUDY)

— Наблюдательное Suicidal Behaviors

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Suicidal Behaviors. Базовые параметры: от 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

THE SURVIVE 2 PROJECT: AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN AND THE EFFICACY OF SECONDARY PREVENTION STRATEGIES

Обзор

The goal of this observational study is to learn more about people who come to emergency departments in Spain after a suicide attempt and to find ways to prevent another attempt. The main questions are whether some personal, social, biological, and clinical factors are linked to a higher risk of trying again, and whether different follow-up strategies can help lower this risk over time. Researchers will follow a total of about 3,600 people who attempted suicide: around 1,800 who were already recruited in a previous study and about 1,800 new participants who will be added in this project, in several hospitals across Spain. Some participants may also be invited to give blood samples, answer online questionnaires, or use smartphone-based tools to understand better changes in mood and suicidal thoughts in daily life. A subset of participants may be invited to join separate clinical trials that test different follow-up programs to prevent another suicide attempt; these trials will be registered and described in their own study records.

Подробное описание

BACKGROUND: Suicide is the leading preventable cause of death in the world. In Spain, the data show a growing trend in recent years, indicating the need to implement evidence-based prevention strategies. OBJECTIVES: The main objective of this study is to continue monitoring a previously established cohort of 1,800 suicide attempts and extend it to include 3,600 cases. The secondary objectives are: 1) to identify risk factors (1a: socioeconomic, psychological, and clinical, 1b: biological, and 1c: genetic) that can predict a repeat attempt, 2) to study suicidal behavior in the pandemic and post-pandemic times, 3) to identify phenotypes related to suicidal ideation and behavior using momentary ecological assessment and 4) to determine the efficacy of secondary prevention programs for suicidal behavior compared with treatment as usual (TaU). METHOD: Multi-center-coordinated cohort study with five nested clinical controlled trials. The participants will be recruited in nine centers distributed in the Spanish territory. The primary variable will be the time to repeat the attempt.

SUB-PROJECT 1: a) long-term follow-up study (5 years) of a cohort of suicide attempts (total n = 3600 cases), b) study of biological and c) genetic markers associated with a suicide attempt. SUB-PROJECT 2: will study suicidal ideation and behavior phenotypes using momentary ecological assessment and experience sampling. SUB-PROJECT 3: will evaluate the efficacy of different secondary prevention programs compared to TaU.

Первичные конечные точки

  • Columbia Suicide Severity Rating Scale (C-SSRS) [Срок оценки: 1 year]
Вторичные конечные точки (12)
  • Patient Health Questionnaire (PHQ-9) [Срок оценки: 1 year]
  • Generalized Anxiety Disorder (GAD-7) [Срок оценки: 1 year]
  • McLean Screening Instrument for BPD (MSI-BPD) [Срок оценки: 1 year]
  • Bruha Life Events [Срок оценки: 1 year]
  • Childhood Trauma Questionnaire (CTQ-SF) [Срок оценки: baseline]
  • Insomnia Severity Index (ISI) [Срок оценки: 1 year]
  • Alcohol Use (AUDIT-C) [Срок оценки: 1 year]
  • Heaviness of Smoking Index (HSI) [Срок оценки: 1 year]
  • Drug Abuse Screening Test (DAST) [Срок оценки: 1 year]
  • Difficulties in Emotion Regulation Scale (DERS-18) [Срок оценки: 1 year]
  • Barratt Impulsiveness Scale (BIS-11) [Срок оценки: 1 year]
  • Health-related Quality of Life (EuroQol-5D) [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Individuals (above 12 years old) who present to participating Spanish hospital emergency departments after a suicide attempt, as defined by self-injurious behavior with at least some intent to die.
  • Able to understand the study procedures and provide informed consent (or assent with parental/guardian consent for minors, according to local regulations)
  • Sufficient proficiency in Spanish to complete study assessments

Критерии исключения

  • Suicide attempts clearly judged as accidental or without suicidal intent
  • Severe cognitive impairment, intellectual disability, or neurological condition that, in the opinion of the clinical team, prevents valid assessment or informed consent
  • Acute medical instability that makes participation in research procedures unsafe.
  • Any condition or circumstance that, in the opinion of investigators, would seriously interfere with participation or follow-up in the cohort.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 2 центра
  • Hospital del Mar — Barcelona
  • Hospital Clinic — Barcelona

Идентификаторы

NCT: NCT07554729 · 2023/11342/I · PI23/00147

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗