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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07314892

Acronym

Psych-GvHD

Enrollment

200

Registered

2026-01-02

Start date

2025-04-08

Completion date

2028-10-31

Last updated

2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairments, Depression Disorders, GVHD, GVHD, Chronic, GVHD - Graft-Versus-Host Disease, Quality of Life

Keywords

GvHD, depression, quality of life, Cognitive impairment

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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).

Countries

Poland

Contacts

Primary ContactJan Puchowski, M.D.

jpuchowski@uck.gda.pl+48 58 584 43 40

Backup ContactAgnieszka Piekarska, MD PhD

agnieszka.piekarska@gumed.edu.pl

Outcome results