Psychiatric Status and Symptom Severity in Graft-versus-Host Disease (GvHD).

Официальное название

Prospective Assessment of the Impact of Psychiatric Status on Clinical Symptom Severity in Patients With Graft-versus-Host Disease (GvHD).

Обзор

This prospective observational study evaluates the association between psychiatric status, GvHD-related symptom severity, and health-related quality of life in patients with graft-versus-host disease. Standardized and validated assessment tools, including the Lee Symptom Scale, will be used to collect psychiatric, clinical, and demographic data.

Подробное описание

Graft-versus-host disease (GvHD) is a significant complication following allogeneic hematopoietic stem cell transplantation and is associated with substantial symptom burden, impaired quality of life, and increased psychiatric morbidity. Despite its clinical relevance, the relationship between psychiatric status and the severity of GvHD-related symptoms remains insufficiently characterized.

This prospective observational study aims to systematically assess psychiatric status, symptom severity, and health-related quality of life in patients with GvHD using standardized and validated instruments. Demographic and clinical data will be collected to establish a comprehensive patient registry. The study will evaluate the association between psychiatric disorders and the intensity of GvHD-related symptoms, as measured by the Lee Symptom Scale, and will explore the bidirectional relationship between depressive symptoms and the clinical course of GvHD. The findings are expected to inform the development of evidence-based recommendations for therapeutic support aimed at improving clinical outcomes and quality of life in patients with GvHD.

Первичные конечные точки

• Identification of depression as a factor associated with increased GvHD-related symptom burden and reduced health-related quality of life. [Срок оценки: Baseline and follow-up assessments during the study period (up to 12 months).]
• Assessment of therapeutic benefits associated with combined antidepressant treatment and psychotherapy, antidepressant treatment alone, and psychotherapy alone. [Срок оценки: Baseline and follow-up assessments during the study period (up to 12 months).]
• Support for the integration of systematic psychiatric assessment into standard multidisciplinary care protocols for patients with graft-versus-host disease. [Срок оценки: Baseline and follow-up assessments during the study period (up to 12 months).]

Критерии участия

Критерии включения

• Adult patients with a clinically established diagnosis of graft-versus-host disease (GvHD) receiving specialist follow-up care at the Bone Marrow Transplantation Outpatient Clinic, University Clinical Center (UCK), Gdańsk.

Критерии исключения

• Severe psychiatric disorders precluding adequate cooperation, terminal-stage multiorgan failure, or refusal to provide informed consent for study participation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Польша · 1 центр

• Department of Hematology and Transplantology — Gdansk

Идентификаторы

NCT: NCT07314892 · KB/90/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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