Actively Recruiting

Age: 18Years - 75Years
All Genders
ID07314892

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

Led by Medical University of Gdansk · Updated on 2026-01-02

200

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand how psychiatric conditions relate to symptom severity and quality of life in patients with graft-versus-host disease (GvHD), a serious complication after stem cell transplantation. The study focuses on assessing mental health status and symptom burden to improve support and care for these patients. It uses standardized tools to measure clinical and psychiatric factors in a systematic way. Patients with chronic GvHD, some diagnosed with depressive or adjustment disorders or cognitive impairment, will be observed to compare symptom severity and psychiatric status. The study does not involve experimental treatments but collects data from patients receiving regular care to evaluate these associations. Follow-up assessments will be conducted over a period of up to 12 months. Participants will provide clinical, psychiatric, and demographic information through validated questionnaires and clinical evaluations. The study will monitor depression levels, symptom burden using the Lee Symptom Scale, and quality of life measures. The research team will assess how psychiatric factors influence GvHD symptoms and explore the effects of different psychiatric treatments on patient outcomes during the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 75 years
  • Clinically diagnosed with graft-versus-host disease (GvHD)
  • Receiving specialist follow-up care at the Bone Marrow Transplantation Outpatient Clinic, University Clinical Center (UCK), Gdańsk
Not Eligible

You will not qualify if you...

  • Severe psychiatric disorders that prevent adequate cooperation
  • Terminal-stage multiorgan failure
  • Refusal to provide informed consent for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 12 months

Participants with graft-versus-host disease are observed to assess psychiatric status, symptom severity, and quality of life using standardized instruments.

Baseline and follow-up assessments during the study period

Trial Site Locations

Total: 1 location

1

Department of Hematology and Transplantology

Gdansk, Pomeranian Voivodeship, Poland, 80-214

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Research Team

J

Jan Puchowski, M.D.

A

Agnieszka Piekarska, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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