The Mind-Body IBD Study: Understanding the Bidirectional Relationship Between Depression and Anxiety With Physical Health Outcomes and Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Psychological distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
研究概览
简要总结
An aspect of IBD care that is often overlooked is mental health treatment. Common mental health problems, such as anxiety and depression are very common in IBD, with a meta-analysis estimating prevalence as high as 25.2% for depression and 32.1% for anxiety. The prevalence of anxiety and depression increases when individuals with active disease are considered, with rates as high as 57.6% for anxiety and 38.9% for depression. Comorbid depression and anxiety in IBD is associated with greater symptom severity, even when statistically controlling for disease activity; more frequent and expensive emergency department visits and inpatient stays, higher costs relating to IBD-related surgery, medication and personal expenditure; noncompliance with medical treatment and finally, increased likelihood of experiencing flares.
However, very few studies attempt to unpick the precise mechanism of these bidirectional relationships.
Indeed, depression and anxiety may have direct effects on physical health through inflammatory or psychoneuroimmunological pathways. Very few studies investigate the longitudinal brain-gut relationship with regards to objective measures of inflammation. Additionally, the indirect effects of mental health are often overlooked. Depression and anxiety are routinely associated with health behaviours, such as diet, physical activity, sleep, and tobacco/alcohol use.These health behaviours are important factors, given their impact on physical health outcomes. Therefore, a thorough investigation is required to ascertain the precise mechanisms that underpin the bidirectional relationship between depression/anxiety and inflammation/physical health, as this will enable practitioners and researchers to establish non-invasive, behavioural treatment targets for this patient group.
AIM The broad aim of this project is to explore whether anxiety/depression has a direct or indirect (via health behaviours) on i) inflammation levels ii) clinical activity and iii) healthcare usage at follow-up, in a population of IBD patients. A secondary aim of the project will be to explore whether changes in disease activity, as measured by self-report measures and faecal calprotectin, explains changes in anxiety and depression symptoms at follow up.
详细描述
Participants will be asked to answer online questionnaires at 3 time points, 6 months apart. They will also be asked to do an at-home stool sample test at the first two time points.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported diagnosis of IBD (pseudo-confirmed with participant's self-reported IBD medication or medication history)
- •Willing and able to give informed consent and participate in the study
- •Aged 18 and over
- •Sufficient command of written and spoken English to understand study procedures and documents, and complete self-report questionnaires
- •UK resident (GP registered)
- •Email address, telephone number and postal address to enable all study procedures
- •Experience at least one flare (requiring medical escalation or medication change) within the last two years
排除标准
- •Under 18 years
- •Lives outside of the UK
- •Insufficient command of English to understand study documents and procedures
- •Not able to give informed consent Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) in the last two weeks.
- •People with a cancer diagnosis
结局指标
主要结局
Psychological distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
时间窗: Month 0, Month 6, Month 12
The PHQ-ADS is a composite measure of the Generalised Anxiety Disorder questionnaire (GAD-7) and the Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress.
Depression: Patient Health Questionnaire - (PHQ-9)
时间窗: Month 0, Month 6, Month 12
Depression. Min score = 0, Max score = 27, with higher scores indicating greater depression.
Anxiety: Generalised Anxiety Disorder scale (GAD-7)
时间窗: Month 0, Month 6, Month 12
Anxiety. Min score = 0, Max score = 21, with higher scores indicating greater anxiety
Fecal Calprotectin
时间窗: Month 0, Month 6
Measure of intestinal inflammation, higher levels indicate greater inflammation.
Health service use
时间窗: Month 0, Month 6, Month 12
4 service use items (GP, psychologist, emergency care, secondary care service) from the client service receipt inventory (CSRI) will be used. Frequency and duration of particular services will be recorded, from which a total time will be calculated. There is no maximum value. Higher scores indicate more health service time used.
IBD activity
时间窗: Month 0, Month 6, Month 12
For Crohn's Disease patients: The Patient-Reported Outcomes for the Assessment of Crohn's Disease Activity (PRO-CD). The scale contains two sub-scales: 1) bowel signs and symptoms, 2) functional symptoms. Each scale is scored separately. There is no total score for the PRO-CD. The first sub-scale starts at 0 and has no maximum value, with greater scores indicating greater bowel signs/symptoms. The second subscale ranges from 0-21, with higher scores indicating greater functional symptoms. For Ulcerative Colitis / unclassified patients: The Patient-Reported Outcomes for Assessment of Ulcerative Colitis (PRO-UC). The scale has 9-items and includes two scales: 1) Bowel signs/symptoms and 2) functional symptoms. The first sub-scale starts at 0 and has no maximum value, with greater scores indicating greater bowel signs/symptoms. The second subscale ranges from 0-21, with higher scores indicating greater functional symptoms.
次要结局
- Body Mass Index(Month 0, Month 6, Month 12)
- Smoking status(Month 0, Month 6, Month 12)
- Alcohol Consumption(Month 0, Month 6, Month 12)
- Physical activity: International Physical Activity Questionnaire(Month 0, Month 6, Month 12)
- IBD medication(Month 0, Month 6, Month 12)
- IBD flares(Month 0, Month 6, Month 12)
- Sleep - the Pittsburgh Sleep Quality Index (PSQI)(Month 0, Month 6, Month 12)
- IBD quality of life - short Inflammatory Bowel Disease Questionnaire (sIBDQ)(Month 0, Month 6, Month 12)
- Medication Adherence - Medication Adherence Report Scale (MARS)(Month 0, Month 6, Month 12)
- Diet - Healthy Eating Assessment(Month 0, Month 6, Month 12)