GVHD, ChronicPsych-GvHDNCT07314892
Psychiatric Status and Symptom Severity in Graft-versus-Host Disease (GvHD).
An observational study of GVHD, Chronic and GVHD - Graft-Versus-Host Disease, run by Medical University of Gdansk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GVHD, Chronic, GVHD - Graft-Versus-Host Disease, GVHD
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 8 Apr 2025to Oct 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Severe psychiatric disorders precluding adequate cooperation, terminal-stage multiorgan failure, or refusal to provide informed consent for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Agnieszka Piekarska, MD PhD contact
Poland1 site, 1 recruiting
- Recruiting
Department of Hematology and Transplantology
Gdansk, Pomeranian Voivodeship, 80-214
Agnieszka Piekarska MD PhD, +48 58 584 43 40, agnieszka.piekarska@gumed.edu.pl
About this study
Official title: 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.
Read the 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.
- Conditions
- GVHD, Chronic, GVHD - Graft-Versus-Host Disease, GVHD, Quality of Life, Depression Disorders, Cognitive Impairments
- Keywords
- GvHD, depression, quality of life, Cognitive impairment
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Graft vs Host Disease, Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Identification of depression as a factor associated with increased GvHD-related symptom burden and reduced health-related quality of life.
Measured: 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.
Measured: 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.
Measured: Baseline and follow-up assessments during the study period (up to 12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start8 Apr 2025
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHD, ChronicStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Puchowski, Medical University of Gdansk
- Investigators
- Jan 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, PolandAgnieszka Piekarska, MD PhD, Principal investigator, Department of Hematology and Transplantology, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, PolandKarol Grabowski, MD PhD, Study director, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314892
- Sponsor's protocol ID
- KB/90/2025
- Acronym
- Psych-GvHD
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of the Impact of Psychiatric Status on Clinical Symptom Severity in Patients With Graft-versus-Host Disease (GvHD).
- ClinicalTrials.gov ID
- NCT07314892
- Acronym / sponsor ID
- Psych-GvHD / KB/90/2025
- Conditions
- GVHD, Chronic, GVHD - Graft-Versus-Host Disease, GVHD, Quality of Life, Depression Disorders, Cognitive Impairments
- Keywords
- GvHD, depression, quality of life, Cognitive impairment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Severe psychiatric disorders precluding adequate cooperation, terminal-stage multiorgan failure, or refusal to provide informed consent for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Agnieszka Piekarska, MD PhD contact
Jan 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
Agnieszka Piekarska, MD PhD principal investigator
Department of Hematology and Transplantology, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland
Karol Grabowski, MD PhD study director
Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GVHD, Chronic and GVHD - Graft-Versus-Host Disease, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Puchowski, M.D. (+48 58 584 43 40, jpuchowski@uck.gda.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.