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Depression and anxiety among hemophilia patients enrolled in clinical trials: a multi-center cohort study
Zhen Peng1, Xiaoyu Zhu2, Chongwei Wang1
1Drug Clinical Trial Institution, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, China.
Insights
Hemophilia patients in clinical trials experience significant depression and anxiety. Acquiring medical information and baseline scores on the PHQ-9 and GAD-7 predict these psychological conditions, necessitating early intervention.
Area of Science:
- Hematology
- Psychiatry
- Clinical Trials
Background:
- Hemophilia patients in clinical trials often face physical and psychological challenges.
- Anxiety and depression prevalence and risk factors in this population remain understudied.
Purpose of the Study:
- To assess the impact of depression and anxiety on hemophilia patients in clinical trials.
- To identify risk factors associated with depression and anxiety in this cohort.
Main Methods:
- A multi-center, cohort study involving 69 hemophilia patients from January to December 2022.
- Baseline (T1) risk factor assessment and psychological symptom evaluation.
- Follow-up evaluation at 3 months (T2) to measure depression and anxiety levels.
Main Results:
- Moderate-to-severe depression increased from 18.75% at T1 to 43.75% at T2; anxiety increased from 7.81% to 25.00%.
- Depression worsened in 35.94% and anxiety in 18.75% of patients.
- Frequent acquisition of medical information (OR 11.378), baseline GAD-7 (OR 1.341), and PHQ-9 (OR 1.465) scores predicted depression and anxiety.
Conclusions:
- Hemophilia patients in clinical trials exhibit significant levels of anxiety and depression.
- Medical information acquisition frequency and baseline PHQ-9/GAD-7 scores are key risk factors.
- Clinical trial participants require education and psychological evaluations for timely intervention.
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.
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