RecruitingRecruiting
Psychiatric Status and Symptom Severity in Graft-versus-Host Disease (GvHD).
NCT07314892 · Medical University of Gdansk
In plain English
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Official title
Prospective Assessment of the Impact of Psychiatric Status on Clinical Symptom Severity in Patients With Graft-versus-Host Disease (GvHD).
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Severe psychiatric disorders precluding adequate cooperation, terminal-stage multiorgan failure, or refusal to provide informed consent for study participation.
Study design
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-04-08
Estimated completion: 2028-10
Last updated: 2026-01-02
Primary outcomes
- • Identification of depression as a factor associated with increased GvHD-related symptom burden and reduced health-related quality of life. (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. (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. (Baseline and follow-up assessments during the study period (up to 12 months).)
Sponsor
Medical University of Gdansk · other
Contacts & investigators
ContactJan Puchowski, M.D. · contact · jpuchowski@uck.gda.pl · +48 58 584 43 40
ContactAgnieszka Piekarska, MD PhD · contact · agnieszka.piekarska@gumed.edu.pl
InvestigatorJan Puchowski, MD · principal_investigator, Department of Hematology and Transplantology, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland
InvestigatorAgnieszka Piekarska, MD PhD · principal_investigator, Department of Hematology and Transplantology, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland
InvestigatorKarol Grabowski, MD PhD · study_director, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland
All locations (1)
Department of Hematology and TransplantologyRecruiting
Gdansk, Pomeranian Voivodeship, Poland