Managing Pain in People With Crohn's Disease: Feasibility Testing of an Acceptance and Commitment Group Therapy Intervention.
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- retention rate
研究概览
简要总结
Pain is a common symptom of inflammatory bowel disease (IBD) and has a significant impact on patient quality of life. Pain will frequently be the presenting complaint and is experienced throughout the disease course. Up to 70% of patients experience pain in active disease, and up to half (20-50%) of patients will experience pain in remission.
Pain in IBD is widely recognised as a biopsychosocial construct, with visceral hypersensitivity, as well as depressive symptoms, anxiety, stress and fear avoidance correlating positively with IBD-pain. There is increasing understanding of the psychological interaction and need for psychological management within IBD. Psychological therapies such as Cognitive Behavioural Therapy (CBT) and acceptance and commitment therapy (ACT) have been used widely in other conditions, such as chronic pain, fatigue and irritable bowel syndrome (IBS).
Although neither ACT nor CBT have been used specifically for pain in IBD, ACT has become a regular therapy in the management of chronic pain and a large number of studies have found it to be effective, particularly in relation to improving functioning and decreasing distress, quality of life and physical wellbeing.
This study design is a crossover randomised controlled trial of ACT versus treatment-as-usual (TAU) in people with CD and chronic abdominal pain. The research team aim to assess the feasibility of ACT for reducing the impact of abdominal pain and its associated psychological burden in people with Crohn's disease (CD). The study will investigate the acceptability of ACT to people with CD and chronic pain, specifically testing issues of eligibility, recruitment, retention rates, patient experience and performance of proposed outcome measures. This will inform the design of a subsequent large multi-centre randomised controlled trial (RCT) with long-term follow-up.
详细描述
Aims:
This study aims to assess the feasibility of ACT for reducing the impact of abdominal pain and its associated psychological burden in people with Crohn's disease (CD). The study will investigate the acceptability of ACT to people with CD and chronic pain, specifically testing issues of eligibility, recruitment, retention rates, patient experience and performance of proposed outcome measures. This will inform the design of a subsequent large multi-centre randomised controlled trial (RCT) with long-term follow-up.
Design and setting:
The design is a crossover randomised controlled trial of ACT versus treatment-as-usual (TAU) in people with CD and chronic abdominal pain. The researchers will invite participants aged 18 and over with a diagnosis of CD attending outpatient clinics at Guy's and St Thomas' NHS Foundation Trust and King's College Hospital NHS Foundation Trust to participate. With ~90 patients with CD attending the clinics each week, this represents one of the largest CD cohorts in the UK. Patients with CD attending the outpatients department will be screened for the presence of chronic pain using standard questionnaires. Individual cases will then be reviewed by a gastroenterologist to assess whether their IBD is stable and they are suitable for the study or whether their pain is part of an acute flare which necessitates a change in medical treatment. Only patients where it is thought pain is part of stable chronic disease will be recruited.
Sample size and recruitment:
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
盲法说明
Not possible die to study design
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Established diagnosis of CD according to clinical notes for a minimum of 6 months
- •Moderate pain, defined as mean score ≥4/10 on both pain severity and pain interference questions the Brief Pain Inventory (BPI) - a validated cut-off to define moderate pain
- •Duration of pain of at least 3 months
- •No changes to CD medication made for the previous 2 months
排除标准
- •Diagnosis of ulcerative colitis or indeterminate colitis
- •Known diagnosis of dementia/psychosis or expressing active suicidal ideation on clinical assessment
- •Currently undergoing other psychological therapy
- •Primary source of pain is non-abdominal
- •Non-fluency in verbal English
- •Pain is identified as a part of acute flare where immediate change in medical treatment is more appropriate
结局指标
主要结局
retention rate
时间窗: Through study completion, an average of 24 weeks
once randomised, do patients continue to engage in the study
recruitment rate
时间窗: Through study completion, an average of 24 weeks
Do patients want to be recruited/ randomised into the study
completion rate
时间窗: Through study completion, an average of 24 weeks
How many patients "complete" the intervention (Attend 5 or more sessions)
次要结局
- Pain Acceptance(Baseline, Week 8, and 24 after randomisation)
- IBD-Distress(Baseline, Week 8, and 24 after randomisation)
- The UK Inflammatory Bowel Disease Quality of Life Questionnaire(Baseline, Week 8, and 24 after randomisation)
- Impairment in functioning:.(Baseline, Week 8, and 24 after randomisation)
- Treatment evaluation(Post treatment Week 8, or 24)
- Pain severity(Screening, Baseline, Week 8, and 24 after randomisation)
- The Inflammatory Bowel Disease-Fatigue questionnaire(Baseline, Week 8, and 24 after randomisation)
- SIMPLE INDEX OF CROHN'S DISEASE ACTIVITY (Harvey & Bradshaw 1980)(Screening, Baseline, Week 8, and 24 after randomisation)
- Depression, stress and anxiety:(Baseline, Week 8, and 24 after randomisation)
- Pain Interference(Screening, Baseline, Week 8, and 24 after randomisation)