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

December 18, 2025 updated by: Jan Puchowski, Medical University of Gdansk

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Recruiting
        • Department of Hematology and Transplantology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 to 75 years, including both female and male participants, with a clinically confirmed diagnosis of graft-versus-host disease (GvHD). Participants are receiving specialist follow-up care at a bone marrow transplantation outpatient clinic and meet the predefined inclusion and exclusion criteria regarding clinical and psychiatric status.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
cGvHD and depression
Patients with chronic graft-versus-host disease (GvHD) diagnosed with depressive disorders, adjustment disorders, or cognitive impairment, diagnosed according to ICD-10 and/or DSM-5 criteria.
cGvHD without depression
Patients with chronic graft-versus-host disease (GvHD) without a diagnosis of depressive disorders, adjustment disorders, or cognitive impairment (control group).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Identification of depression as a factor associated with increased GvHD-related symptom burden and reduced health-related quality of life.
Time Frame: Baseline and follow-up assessments during the study period (up to 12 months).
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.
Time Frame: Baseline and follow-up assessments during the study period (up to 12 months).
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.
Time Frame: Baseline and follow-up assessments during the study period (up to 12 months).
Baseline and follow-up assessments during the study period (up to 12 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Gdansk

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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
  • Principal Investigator: Agnieszka Piekarska, MD PhD, Department of Hematology and Transplantology, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland
  • Study Director: Karol Grabowski, MD PhD, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KB/90/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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