Healthy volunteer profile: Levels of anxiety, depression, socioeconomic aspects and candidates’ motivations of participation in phase I clinical trials

Abstract

Introduction

Healthy volunteers participate in phase I clinical trials mainly in search of an economic compensation; their economic instability may constitute a vulnerability factor for anxiety/depression.

Objectives

To select suitable and rapid screening tests for anxiety and depression in healthy volunteers, to know their socioeconomic situation and to identify the main reason for their participation.

Methods

Cross-sectional study, under a nonparametric statistical analysis and ROC curve analysis. Goldberg's Anxiety and Depression Scale (GADS) (fast test) and the Beck Depression (BDI-II) and Anxiety (BAI) Inventories (standard tests) were applied to all participants.

Results

One hundred and thirty-nine potential candidates were recruited; the average age was 32 years (SD = 8.8); 53.9% were students, 43.9% employers and 2.2% were unemployed; 85.6% had university studies, 13.7% secondary education and .7% primary studies. GADS, BDI-II and BAI results were: 24.5% volunteered with anxiety and 15.8% with depression (GADS); anxiety levels (BAI): 60.4% had null, 25.9% mild, 11.5% moderate and 2.2% severe; depression (BDI-II): 87.8% had null, 5.8% mild, 5.8% moderate and .7% severe. Socioeconomic characteristics: 48.2% low stratum, 43.2% medium, 5.7% medium high and 2.8% high. Motivations: 46.1% for economic compensation, 35.9% contribution to science, 14.4% for curiosity and 3.6% access to health.

Conclusions

GADS shows insufficient capacity to discriminate between anxiety/depression and the use of BAI and BDI-II is suggested; anxiety and depression levels were higher in healthy volunteers than the prevalence in the general population but lower when compared to university population; employment status was mostly composed of university students with low socioeconomic characteristics and a high economic motivation.