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

NCT07314892 | Recruiting

• 1 other identifier: KB/90/2025
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

GvHD; depression; quality of life; Cognitive impairment

Outcome Measures

Primary Outcomes (3)

• 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).

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Severe psychiatric disorders precluding adequate cooperation, terminal-stage multiorgan failure, or refusal to provide informed consent for study participation.

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of Hematology and Transplantology

Gdansk, Pomeranian Voivodeship, 80-214, Poland

RECRUITING

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Graft vs Host Disease; Cognitive Dysfunction; Depression

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Karol Grabowski, MD PhD

  Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland

  STUDY DIRECTOR

Central Study Contacts

Jan Puchowski, M.D.

CONTACT

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

Agnieszka Piekarska, MD PhD

CONTACT

agnieszka.piekarska@gumed.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: April 8, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)