Psychiatric Symptoms and Quality of Life in Graft-versus-Host Disease
Official title: Prospective Assessment of the Impact of Psychiatric Status on Clinical Symptom Severity in Patients With Graft-versus-Host Disease (GvHD).
Run by Medical University of Gdansk · NCT07314892 · Data updated 2026-11-12
This project will see if psychiatric symptoms like depression are linked to GvHD symptom severity and health-related quality of life in adults with graft-versus-host disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Medical University of Gdansk Academic / other |
| Locations | 1 site (Gdansk, Pomeranian Voivodeship) |
| Status | Recruiting |
| Started | April 8, 2025 |
| Main results expected | April 2028 |
| Study ends | October 2028 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07314892 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a clinically confirmed diagnosis of GvHD who receive specialist follow-up care at the Bone Marrow Transplantation Outpatient Clinic, University Clinical Center (UCK) in Gdańsk are ideal candidates.
✕Probably not a fit
Patients with severe psychiatric disorders that prevent cooperation, those with terminal multiorgan failure, or people who cannot attend follow-up at the Gdańsk clinic are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational project enrolling adults with clinically established GvHD at the Bone Marrow Transplantation Outpatient Clinic, University Clinical Center (UCK) in Gdańsk. Participants will complete standardized, validated instruments including the Lee Symptom Scale and structured psychiatric questionnaires while clinical and demographic data are recorded to build a patient registry. The analysis will examine associations between psychiatric diagnoses, trajectories of depressive symptoms, and the intensity of GvHD-related symptoms, and will explore potential bidirectional relationships over time. Findings are intended to inform evidence-based recommendations for psychological and clinical support to improve patient outcomes and quality of life.
Why it matters
Potential benefit: If successful, the findings could help target mental health and symptom-management interventions to improve clinical outcomes and quality of life for people with GvHD.
How similar studies have gone: Prior observational work in chronic illnesses has linked depression to worse symptom burden and quality of life, but the specific relationship between psychiatric status and GvHD symptom severity remains underexplored.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Department of Hematology and Transplantology
Gdansk, Pomeranian Voivodeship, Poland Recruiting
Study contacts
- Principal investigator: Jan Puchowski, MD — 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
- Study coordinator: Jan Puchowski, M.D.
- Email: jpuchowski@uck.gda.pl
- Phone: +48 58 584 43 40
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.