A Study to Describe the Burden of Mental Ill Health in Inflammatory Bowel Disease Patients Using Advanced Therapies, and to Identify Any Associations Between Common Mental Health Problems and the Efficacy of Such Advanced Therapies (IBDmind)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Patient Reported Outcome-2 (PRO-2)
研究概览
简要总结
People with Inflammatory bowel disease (IBD) can get challenging symptoms. Things like diarrhoea, tummy pain and being tired all the time are common. People often get IBD in their teens or twenties. They often find working, studying and relationships hard. IBD can't be cured, so it lasts for life.
When IBD is hard to treat, we use advanced treatments, but these don't always work. When they do work the effect can wear off. This happens in 2 of 5 people within a year in research studies. There are some things that we know make them wear off. There are lots more reasons that we don't understand yet. We think anxiety, depression and stress make these treatments more likely to wear off. Previous research has suggested that people with IBD do worse if they have anxiety, depression or stress.
The investigators want people with IBD to complete questionnaires to see if they are affected by anxiety, depression or stress when they are taking advanced therapies. The investigators will follow those people to see if the effect of their treatment wears off.
People living with IBD will contribute to the running and fine tuning of this research. Many of those that have engaged with us so far have said that their disease was worse when their mental health was worse. They were generally supportive of this study to see how anxiety, depression and stress effects IBD in people using advanced therapies.
The investigators have talked to a national charity about our work. They will help share the findings so that patients, care givers and other stakeholders will be able to read about them. The results will be published so that doctors and researchers can use them.
详细描述
The treatment of moderate to severe Inflammatory Bowel Disease (IBD) now consists of a wide selection advanced therapies1. Despite these, the efficacy of advanced therapy has reached a ceiling at approximately 40% of patients achieving remission. Furthermore, a significant proportion will lose response to the medication within 1 year of starting2-4, which is likely to be multi-factorial.
There is a recognised association between IBD and common mental health problems, specifically anxiety, depression and perceived stress, but it is not known whether these impact the effectiveness of IBD treatment.
The bidirectional relationship between mental wellbeing and IBD has been described in a recent meta-analysis5. Patients with anxiety and depression are more likely to develop IBD compared to matched controls without IBD6. This relationship predates IBD presentation by up to 5 years. Therefore, it appears that a complex relationship between IBD and anxiety, depression and perceived stress exists. IBD patients with concurrent anxiety, depression and perceived stress are more likely to have more severe IBD, including; exacerbations, hospital admissions, and need for surgery5.
High levels of perceived personal stress are associated with increased risk of disease exacerbations7. A single study from 2005 demonstrated worse IBD outcomes in patients with severe depression compared to mentally well patients when treated with a single dose of Infliximab (albeit in a practice which is now obsolete). This suggests severe depression is associated with worse outcomes from advanced therapies but further research is needed to validate this association8.
Data to describe a relationship between IBD and anxiety, depression and perceived stress, in patients on advanced therapies is limited. Up to 20% of IBD patients are now progressing to advanced therapies compared to 5% in 20109. Such data is important to consider if intervention for anxiety, depression and perceived stress could improve durability of advanced therapies.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of ulcerative colitis, or Crohn's disease, based upon either the outcome of the local multidisciplinary team, clinic documentation or in the opinion of the investigator
- •Patients receiving maintenance infliximab or vedolizumab by regular intravenous infusion
- •Patients willing and able to give informed consent
- •Patients aged 16 or over
排除标准
- •Patients cannot be recruited while receiving their loading dose of infusions, but may be included once complete.
- •Patients should not currently be planned for surgery within the next 12 months
- •Patients should not currently be planned to switch to another advanced therapy within the next 12 months
- •Patients should not currently be planned for a drug holiday within the next 12 months
- •Patients should not have a stoma (This would invalidate the PRO-2 outcome measure)
- •Patients should not currently be pregnant
- •Patient currently receiving subcutaneous infliximab or vedolizumab
结局指标
主要结局
Patient Reported Outcome-2 (PRO-2)
时间窗: Every 4 weeks over the course of a year
PRO-2 is an established patient reported outcome measure for IBD. There are separate measurement tools for UC and CD. In UC patients report the rectal bleeding sub-score and stool frequency sub-score from the clinical Mayo score. In CD patients report 3 days of the number of liquid or soft stools and severity of abdominal pain. In both UC and CD the score is well validated to Mayo clinical score and CDAI respectively, and to faecal biomarkers.
Patient Health Questionnaire-9 (PHQ-9)
时间窗: Every 4 weeks over the course of a year
PHQ-9 is a self-administered measure of depressive symptoms over the previous 2 weeks. Questions include 9 domains, asking patients to report the frequency of each. PHQ is-9 is mapped to the DSM-4 diagnosis of major depression and therefore offers robust evidence of depression. Although not specifically designed for physical health problems, validity in this group has been demonstrated. PHQ-9 is also sensitive to change, therefore is well suited to serial measurements.
Generalised Anxiety Disorder-7 (GAD-7)
时间窗: Every 4 weeks over the course of a year
GAD-7 is a self-administered measure of anxiety over the proceeding 2 weeks. Questions cover 7 domains asking patients to record the frequency of each. GAD-7 is the current UK standard for scale for anxiety utilised in primary care.
Perceived Stress Scale (PSS-10)
时间窗: Every 4 weeks over the course of a year
PSS-10 is a self-administered measure of symptoms suggestive of stress over the previous 4 weeks. Questions include ;10 domains, asking patients to report the subjective frequency of each. Stress is an important outcome measure as there is a recognised association with active IBD.
Generalised Anxiety Disorder-7 (GAD-7)
时间窗: Every 4 weeks over the course of a year
GAD-7 is a self-administered measure of anxiety over the proceeding 2 weeks. Questions cover 7 domains asking patients to record the frequency of each. GAD-7 is the current UK standard for scale for anxiety utilised in primary care.
Perceived Stress Scale (PSS-10)
时间窗: Every 4 weeks over the course of a year
PSS-10 is a self-administered measure of symptoms suggestive of stress over the previous 4 weeks. Questions include ;10 domains, asking patients to report the subjective frequency of each. Stress is an important outcome measure as there is a recognised association with active IBD.
Patient Reported Outcome-2 (PRO-2)
时间窗: Every 4 weeks over the course of a year
PRO-2 is an established patient reported outcome measure for IBD. There are separate measurement tools for UC and CD. In UC patients report the rectal bleeding sub-score and stool frequency sub-score from the clinical Mayo score. In CD patients report 3 days of the number of liquid or soft stools and severity of abdominal pain. In both UC and CD the score is well validated to Mayo clinical score and CDAI respectively, and to faecal biomarkers.
Patient Health Questionnaire-9 (PHQ-9)
时间窗: Every 4 weeks over the course of a year
PHQ-9 is a self-administered measure of depressive symptoms over the previous 2 weeks. Questions include 9 domains, asking patients to report the frequency of each. PHQ is-9 is mapped to the DSM-4 diagnosis of major depression and therefore offers robust evidence of depression. Although not specifically designed for physical health problems, validity in this group has been demonstrated. PHQ-9 is also sensitive to change, therefore is well suited to serial measurements.
次要结局
未报告次要终点