Personality Traits and Its Impact on Quality of Life and Clinical Outcome Evaluation in Patients With Crohn's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- IBDQ
研究概览
简要总结
Quality of life is recommended as one of essential parameters to evaluate treatment effect and clinical outcome in patients with Crohn's disease (CD). Recent studies reported that several disease-unrelated variables may affect quality of life in CD patients. This study is dedicated to investigate the influence of various personality traits on quality of life, and whether or not they should be taken into account when evaluating clinical outcomes in patients with CD.
详细描述
This is a prospective, single-center study.
All enrolled patients are divided into 2 groups:
- Group 1: quiescent CD group (CDAI≤150 points)
- Group 2: active CD group (CDAI>150 points)
All enrolled patients are required to accomplish the following questionnaires at visit:
- Inflammatory Bowel Disease Questionnaire (IBDQ)
- Neuroticism (N) and Lie (L) subscale of the Eysenck Personality Inventory (EPI)
- Hospital Anxiety and Depression Scale (HADS)
- Buss-Perry Aggression (BPA) questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •a definite diagnosis of CD
排除标准
- •current or previous mental disorders
- •receiving or once received psychotherapy
- •presence of major medical conditions (such as necessity of an operation)
- •chronic disease history other than inflammatory bowel disease
- •unwilling to participate in or cannot accomplish current study
结局指标
主要结局
IBDQ
时间窗: one week
Inflammatory Bowel Disease Questionnaires (IBDQ) is the most widely used and validated disease-specific instrument, which contains 32 items and assesses four aspects (subscales) of quality of life: emotional function (12 items), social function (5 items), bowel function (10 items) and systemic symptom (5 items).
次要结局
- Eysenck Personality Inventory (EPI)(one week)
- Hospital Anxiety and Depression Scale (HADS)(one week)
- Buss Perry Aggregation (BPA) questionnaire(one week)
研究者
Jianan Ren
Vice president of department of surgery, Jinling Hospital
Jinling Hospital, China