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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMedical University of Gdansk

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: cGvHD and depression
Group B: cGvHD without depression

Trial outcomes

Primary outcomes

1

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).
2

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).
3

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).

Secondary outcomes

Other outcomes

Sponsors and contacts

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