Depression and anxiety among hemophilia patients enrolled in clinical trials: a multi-center cohort study

Abstract

Hemophilia patients enrolled in clinical trials often exhibit various physical and psychological symptoms. However, little is known about anxiety and depression among them. This study assessed the effects of depression and anxiety on hemophilia patients enrolled in clinical trials and identified risk factors for these disorders. A multi-center, cohort study was conducted from January to December 2022. Sixty-nine hemophilia patients who enrolled in clinical trials participated at baseline (T1, prior to treatment initiation) and completed the informed consent. Risk factors were measured at baseline to predict depression and anxiety at 3 months (T2). Sixty-four hemophilia patients were included in the final analysis. More hemophilia patients had moderate-severe depression (28 [43.75%]) and anxiety (16 [25.00%]) at T2 than at T1 (12 [18.75]), (5 [7.81%]). Depression was aggravated in 23 (35.94%) patients and anxiety was aggravated in 12 (18.75%) patients. Frequently acquired medical information (OR 11.378, CI 1.319-98.114, P = 0.027), baseline GAD-7 (OR 1.341, CI 1.015-1.772, P = 0. 039) and PHQ-9 (OR 1.465, CI 1.039-2.065, P = 0.029) are important factors predicting depression and anxiety in hemophilia patients. Hemophilia patients enrolled in a clinical trial have significant anxiety and depression. The frequency of acquiring medical information and the baseline PHQ-9 and GAD-7 scores were risk factors for anxiety and depression. Thus, hemophilia patients should receive education regarding clinical trials and undergo evaluations of their anxiety and depression; these changes will enable prompt detection of their psychological burden and identify potential psychological intervention strategies.

Keywords: Anxiety; Clinical trial; Depression; Hemophilia.