Yang Chen, Chengzhen Lyu, Daiyu Yang, Hao Tang, Liang Gong, Jian Li, Xiaoqing Li, Dong Wu
State Key Laboratory of Complex Severe and Rare Diseases, Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Front Med (Lausanne). 2024 Aug 30;11:1452187. doi: 10.3389/fmed.2024.1452187. eCollection 2024.
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.
功能性胃肠疾病（FGIDs）影响着全球超过40%的人群，并对生活质量产生影响。很大一部分FGIDs患者合并焦虑和抑郁。传统的心理障碍筛查工具可能缺乏全面性。振动图像技术目前能够通过高帧率摄像头和微动作的计算机分析对心理指标进行非接触式客观分析。因此，本研究旨在：（1）探索使用振动图像技术作为一种非接触式客观方法来评估FGIDs患者的心理状态，将该技术与医院焦虑抑郁量表（HADS）进行比较以评估其筛查效果；（2）观察相同常规治疗后合并或未合并心理障碍的FGIDs患者的治疗结果。
这是一项前瞻性、单中心观察性试验。将对276名到北京协和医院就诊的FGIDs门诊患者同时采用HADS和振动图像技术进行评估，进而评估该技术的筛查效果。患者将被分为两组（有或没有心理障碍）。主要终点是总体改善率，具体指达到李克特评分大于或等于4的患者比例。次要终点包括评估诸如IBS-SSS等症状评估得分是否降低超过50%。此外，该研究将使用SF-36问卷评估健康状况和生活质量的变化以及患者对治疗的满意度。此外，治疗后将通过振动图像技术和HADS重新评估心理状态，以评估合并心理因素对FGIDs治疗的影响。
