Evaluation of comorbid psychological disorders in functional gastrointestinal disorders patients by vibraimage technology: protocol of a prospective, single-center trial.

Abstract

Functional gastrointestinal disorders (FGIDs) affect over 40% of individuals globally, and impact the quality of life. A significant portion of FGIDs patients comorbids with anxiety and depression. Traditional screening tools for psychological disorders may lack comprehensiveness. Vibraimage technology currently enables non-contact, objective analysis of psychological indicators through high-frame-rate cameras and computer analysis of micro-movements. Therefore, this study aims to (1) explore the use of vibraimage technology as a non-contact objective method to assess the psychological status of FGIDs patients, comparing this technology with the Hospital Anxiety and Depression Scale (HADS) to evaluate its screening efficacy, and (2) observe the therapeutic outcomes of FGIDs patients with or without comorbid psychological disorders after the same conventional treatment. This is a prospective, single-center observational trial. 276 FGIDs outpatients who visit Peking Union Medical College Hospital will be evaluated simultaneously by HADS and vibraimage technology, then to evaluate the screen efficacy of this technology. The patients will be allocated into two groups (those with or without psychological disorders). The primary endpoint is the overall rate of improvement, specifically referring to the proportion of patients who achieved Likert scores greater than or equal to 4. The secondary endpoints encompass evaluating whether there is a reduction of more than 50% in symptom evaluation scores such as IBS-SSS. Additionally, the study will assess changes in health status and quality of life using SF-36 questionnaires and the patients' satisfaction with treatment. Furthermore, psychological status will be reassessed by vibraimage technology and HADS after treatment to evaluate the effect of combined psychological factors on FGIDs treatment.