Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 8
- 主要终点
- Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab
研究概览
简要总结
It has been shown that emotional health issues, such as state anxiety, are more prevalent in patients suffering from inflammatory bowel disease (IBD) compared to physically healthy subjects.
Such findings have to be taken into consideration when making an educated guess that psychological factors such as depression and anxiety in particular interact with the course of Crohns disease. Therefore the treatment of the underlying disease may have a significant influence on the level of psychological disorders.
Several studies have shown that treatment with tumor necrosis factor alpha (TNF-α) antibodies ameliorates the emotional/psychological status of patients, however the impact of adalimumab therapy on anxiety correlated with the status of inflammatory bowel disease (IBD) remains unclear.
The primary objective of this study was to describe and evaluate changes in levels of anxiety assessed by validated patient questionnaires after 6 months of treatment with adalimumab.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients for whom Adalimumab (Humira) therapy is indicated and has been prescribed according to the product label and who meet the following criteria:
- •Male and female patients aged 18 to 65 years suffering from severe active Crohns Disease, attending a routine medical visit.
- •Able to complete questionnaires.
- •Patients with status active severe Crohns disease which required immunosuppressive treatment
- •Patients must fulfil international and national guidelines for the use of a biologic therapies in Crohns Disease (Chest X-ray and interferon gamma release assay (IGRA) or PPD (purified protein derivative)-skin test negative for tuberculosis).
- •Patients have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
- •Patients who have been prescribed in line with the European Summary of Product Characteristics (SMPC)
排除标准
- •The following patients will not be included in this observational study:
- •Previous therapy with TNF-α blocker within the last 8 weeks
- •Active Central Nervous System opportunistic infections or Central Nervous System malignancies.
- •History of Cerebrovascular Accident
- •Abuse of illicit substances (such as psychoactive drugs) within the previous 3 months
- •Change of medication-based treatment of generalized anxiety and panic disorder, psychiatric disorder
- •No informed consent
- •Contraindication to adalimumab (Humira) therapy according to the SMPC
- •Current or planned pregnancy
- •Lactation according to SMPC
- •Planned change of site within the next 24 weeks.
结局指标
主要结局
Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab
时间窗: Baseline and Visit 3 [Month 6]
The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab
时间窗: Baseline and Visit 3 [Month 6]
HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.
Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab
时间窗: Baseline and Visit 3 [Month 6]
HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.
Change in State Trait Anxiety Index (STAI) State Scores From Baseline to After 6 Months of Treatment With Adalimumab
时间窗: Baseline and Visit 3 [Month 6]
The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
次要结局
- Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit(Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6])
- State Trait Anxiety Index (STAI) State Scores by Visit(Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6])
- Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit(Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6])
- Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit(Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6])
- Harvey-Bradshaw Index (HBI) Scores by Visit(Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6])
- State Trait Anxiety Index (STAI) Trait Scores by Visit(Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6])