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Набор скоро начнётся NCT07443033

Psychosocial Factors in Dual Diagnosis in a General Hospital

Наблюдательное Dual Diagnosis Substance Use Disorder Mental Disorders

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: Dual Diagnosis, Substance Use Disorder, Mental Disorders. Базовые параметры: от 18 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 →
Официальное название

Psychosocial Protective Factors and Clinical-Functional Outcomes in Hospitalized Patients With Dual Diagnosis: An Observational, Cross-Sectional, Single-Center Study

Обзор

Dual diagnosis, defined as the co-occurrence of a mental disorder and a substance use disorder, is frequently associated with increased clinical severity, functional impairment, and poorer health outcomes. Identifying psychosocial protective factors related to better clinical and functional outcomes is essential to improve patient care and treatment planning. The aim of this observational, cross-sectional, single-center study is to analyze psychosocial protective factors and their association with clinical-functional outcomes in hospitalized patients with dual diagnosis. The study will be conducted in a general hospital setting and will include adult inpatients diagnosed with dual diagnosis according to clinical criteria. Sociodemographic, clinical, and psychosocial variables will be collected using standardized assessment tools and clinical records. The results of this study are expected to contribute to a better understanding of psychosocial factors associated with clinical severity and functional outcomes in patients with dual diagnosis, supporting more comprehensive and patient-centered care approaches.

Подробное описание

Dual diagnosis, characterized by the coexistence of a mental disorder and a substance use disorder, represents a major clinical challenge in mental health services. Patients with dual diagnosis frequently present greater clinical complexity, higher rates of hospitalization, functional impairment, and difficulties in treatment adherence. Beyond clinical variables, psychosocial factors may play a relevant role as protective elements influencing clinical and functional outcomes.

This study is designed as an observational, cross-sectional, single-center study conducted in a general hospital. The study population will consist of adult patients hospitalized with a clinical diagnosis of dual diagnosis. Participants will be recruited during their hospital admission according to predefined inclusion and exclusion criteria.

Data collection will include sociodemographic information, clinical variables related to psychiatric and substance use disorders, and psychosocial factors considered potentially protective. Clinical-functional outcomes will be assessed using standardized instruments and information obtained from medical records. All data will be collected as part of routine clinical assessment, without introducing any experimental intervention.

The primary objective of the study is to evaluate the association between psychosocial protective factors and clinical-functional outcomes in hospitalized patients with dual diagnosis. Secondary objectives include describing the sociodemographic and clinical characteristics of the study population and exploring the relationship between psychosocial variables and indicators of clinical severity.

This study does not involve the administration of investigational drugs or devices and does not modify standard clinical practice. The research protocol has been reviewed and approved by the corresponding Ethics Committee. The findings are expected to provide relevant information to support a biopsychosocial approach in the assessment and management of patients with dual diagnosis.

Первичные конечные точки

  • Medication adherence measured by Simplified Medication Adherence Questionnaire (SMAQ) [Срок оценки: Baseline (within 72 hours of hospital admission)]
Вторичные конечные точки (5)
  • Observed treatment adherence during hospitalization (clinical proxy index 0-3) [Срок оценки: At hospital discharge (average length of stay approximately 10-14 days)]
  • Clinical severity measured by Clinical Global Impression - Severity scale (CGI-S) [Срок оценки: Baseline (within 72 hours of hospital admission)]
  • Health-related quality of life measured by EuroQol-5D-5L index score [Срок оценки: Baseline (within 72 hours of hospital admission)]
  • Self-rated health status measured by EQ-5D Visual Analog Scale (VAS) [Срок оценки: Baseline (within 72 hours of hospital admission)]
  • Suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Baseline (within 72 hours of hospital admission)]

Критерии участия

Критерии включения

  • Adults (≥18 years).
  • Hospitalized patients with a clinical diagnosis of dual diagnosis.
  • Ability to provide informed consent.

Критерии исключения

  • Severe cognitive impairment or acute clinical condition preventing assessment.
  • Refusal or inability to provide informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Испания · 1 центр
  • Hospital Virgen del Puerto — Plasencia

Идентификаторы

NCT: NCT07443033 · DUAL-HVP-OBS-2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗