Psychological Intervention for Fatigue in Inflammatory Bowel Diseases: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 155
- 主要终点
- FACIT fatigue scale
研究概览
简要总结
The investigators would like to evaluate the effect of a multicomponent psychological treatment on fatigue as a symptom of patients with inflammatory bowel diseases (IBD). The intervention will be a combined program consisting of a psychological intervention (Acceptance and Commitment Therapy) and a behavioral intervention (implementation of frequent short naps and graded increase of physical activity). Next to the hypothesized effect on fatigue, the investigators will also measure the effect on fatigability, IBD related disability, anxiety, depression, stress, disease acceptance and perceived control as well as (biomarkers of) disease activity.
详细描述
Ulcerative colitis (UC) and Crohn's disease (CD) are chronic inflammatory bowel diseases that significantly impact patients' quality of life. One of the most prevalent and distressing symptoms associated with both UC and CD is fatigue, which can arise from both the physiological effects of the diseases and the psychological burden of living with a chronic condition. Despite the importance of addressing fatigue, traditional treatment approaches often focus primarily on physical symptoms, neglecting the multifaceted nature of fatigue that includes emotional and lifestyle factors.
This research aims to evaluate a novel multicomponent intervention that combines Acceptance and Commitment Therapy (ACT), frequent napping, and Graded Activity. Each component targets different dimensions of fatigue:
Acceptance and Commitment Therapy (ACT): ACT is a mindfulness-based therapeutic approach that encourages individuals to accept their thoughts and feelings rather than fighting against them. It promotes psychological flexibility and helps individuals commit to actions aligned with their values, even in the presence of discomfort. Previous studies have demonstrated ACT's effectiveness in managing chronic pain, anxiety, and other health-related issues, suggesting its potential benefit in addressing fatigue in chronic conditions like UC and CD.
Frequent Napping: Napping has been shown to help mitigate daytime fatigue, improve alertness, and enhance overall well-being. For patients with UC and CD, who often experience irregular sleep patterns due to their symptoms, implementing structured napping could serve as a valuable strategy for managing fatigue. However, this may be less suitable for patients working fulltime.
Graded Activity: Graded Activity is a structured approach to increase physical activity gradually. It involves setting achievable goals and progressively increasing activity levels, which can help mitigate fatigue and improve overall physical functioning. In the context of UC and CD, where patients may experience cycles of flare-ups and remission, Graded Activity can provide a tailored strategy to reintroduce physical activity safely and effectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •Males and females 18-70 years old.
- •Patients with a diagnosis of ulcerative colitis (UC), Crohn's disease (CD), inflammatory bowel disease type unclassified (IBDU) based on radiology, endoscopy and/or histology
- •Patients with a disease duration of more than one year
- •Patients with a score of <30 on the FACIT Fatigue scale
- •Patients possessing a smartphone
- •Patients with an availability to commit to daily behavioural changes
- •Patients being fluent in Dutch.
排除标准
- •Patients that initiated new IBD medication (steroids, mesalamine, thiopurines, methotrexate, biologicals or small molecules) in the past three months prior to screening
- •Patients with objective signs of active disease (CRP<10mg/L or faecal calprotectin <250µg/g) at screening
- •Participation in an interventional Study with an investigational medicinal product (IMP) or device at screening
- •Patients with planned surgery at screening
- •Patients with an iron (<65 µg/dL), vitamin D (<11 µg/L), vitamin B12 (<197 ng/L) or folic acid (<3.9 µg/L) deficiency or malnutrition (weight loss >10-15% within six months, BMI <18.5 kg/m², NRS >5 or serum albumin <30 g/L) at screening
- •Patients with thyroid dysfunction or hypophosphatemia at screening
- •Patients with physical injury (according to researcher's interpretation) at screening
- •Patients with self-reported sleep disturbance or periods of apnoea at screening
- •Patients with BMI >30 kg/m² at screening
- •Patients with present or past diagnosis of severe psychiatric disease diagnosis (ongoing major depression, schizophrenia, bipolar disease, ongoing substance abuse) at screening
- •Patients that initiated new psychotropic medication or had a changed dosage of psychotropic medication in the past three months prior to screening
研究组 & 干预措施
Early intervention group
Group starts immediately with the 14-week intervention
干预措施: Early start (Behavioral)
Early intervention group
Group starts immediately with the 14-week intervention
干预措施: Multicomponent psychological intervention (Behavioral)
Late intervention group
Group starts with 14-week intervention after 28 weeks
干预措施: Multicomponent psychological intervention (Behavioral)
Late intervention group
Group starts with 14-week intervention after 28 weeks
干预措施: Late start (after 28 weeks) (Behavioral)
结局指标
主要结局
FACIT fatigue scale
时间窗: 14 weeks
The percentage of participants achieving a ≥20% improvement on the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (indicating reduced fatigue) between baseline and week 14.
次要结局
未报告次要终点