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临床试验/NCT02350920
NCT02350920已完成不适用

A Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) in Inflammatory Bowel Disease

University College Dublin1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
1
主要终点
Changes in stress measured by the Depression, Anxiety and Stress Scale (DASS 21)

研究概览

简要总结

Over 18,000 Irish people are affected by the inflammatory bowel diseases (IBD), Crohn's disease and ulcerative colitis. These illnesses often arise at a young age and can be associated with significant physical disability. In addition, there is considerable psychosocial disability associated with IBD. Previous studies have suggested that simple psychological interventions may be valuable in improving quality of life and may even improve disease activity. However, there has been no comprehensive trial to determine the precise effect of psychological interventions on quality of life (QOL), stress or disease activity. Our aim is to conduct a randomised controlled trial of a simple psychological intervention to determine it's effect on QOL and stress

详细描述

The inflammatory bowel diseases (IBD), which include Crohn's disease and ulcerative colitis, are chronic conditions that often arise in young patients and may lead to a lifetime of physical disability. Psychological disabilities are also prevalent in patients with chronic diseases and epidemiological studies indicate that IBD patients are at increased risk of anxiety and mood disorders, with depression rates more than double that of matched community samples (27% versus 12%). IBD patients are also at increased risk of illness-related psychological difficulties including body image concerns, sexual problems and reduced self-esteem.

Therapeutic approaches to inflammatory bowel disease naturally focus on treatments that minimise disease activity and normalise physical function. Thus, there has been considerable research conducted on 5 ASA medications, steroids, immune modulators and biologic agents. In contrast, little attention has been paid to important, but 'low-technology', issues including quality of life and psychological comorbidities including depression, anxiety, stress, altered body image, sexuality, illness attitudes, self-esteem and other psychosocial IBD co-morbidities. Nevertheless, patient reported data and outcomes are increasingly being incorporated into research that informs strategic healthcare documents that, in turn, help formulate healthcare policy. Contemporary European and British guidelines now emphasise the benefits of a patient centred service that supplies psychological as well as medical support.

In addition to the burden that psychological disease places upon IBD patients, there is evidence that psychological morbidity and stress is also associated with disease activity. IBD patients with depression experience more disease flares than those with no diagnosable psychological condition and a Canadian study has also suggested that stress can be associated with disease flares. In contrast, a Spanish study on 163 patients concluded that stressful life events do not trigger exacerbations in IBD patients. Overall, it is likely that the relationship between stress and disease activity is bi-directional with each one influencing the other to some extent.

To date, interventions aimed at reducing psychological distress in IBD have tended to focus on either psychological education, stress management including relaxation techniques and autogenic training, psychodynamic psychotherapy, cognitive behavioral therapy and hypnosis. Studies have been variable with regard to psychological content and almost all had multiple methodological limitations, making it difficult to draw conclusions about the value of these interventions. Perhaps the most comprehensive review of psychological studies in IBD, which included 16 studies, concluded that while psychological interventions can make a positive contribution to best practice multidisciplinary IBD treatment, well designed studies are needed to determine the efficacy of different treatments.

We aim to conduct a multicenter randomised controlled trial to determine the efficacy of Acceptance and Commitment Therapy (ACT) on the psychological wellbeing of IBD patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

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

  • •IBD patients who have inactive disease and either a stressometer score of ≥5 or a Short Health Scale score of ≥80 will be eligible for inclusion

排除标准

  • •Patients under 18 years,
  • •Patients over 65 years,
  • •pregnant females,
  • •patients currently attending psychiatric services,
  • •patients currently receiving antidepressant medication,
  • •patients who have received steroid medications in the past three months,
  • •patients who have previously undergone a stress management programme (relaxation techniques, autogenic training, psychodynamic psychotherapy, cognitive behavioural therapy, hypnosis).

研究组 & 干预措施

Acceptance and Committment Therapy (ACT)

Active Comparator

This group will consist of patients who will receive ACT therapy.This intervention will run with 8-12 participants in each group for a duration of 8 weeks. Each group session will last 1-1.5 hours.

干预措施: Acceptance and Committment Therapy (ACT) (Behavioral)

Control

No Intervention

The control group will consist of patients who will receive no ACT therapy during the 26 week st udy period

结局指标

主要结局

Changes in stress measured by the Depression, Anxiety and Stress Scale (DASS 21)

时间窗: 20 weeks

Changes in stress measured by the Depression, Anxiety and Stress Scale (DASS 21)

次要结局

  • Changes in quality of life measured by the Short Health Scale (SHS)(20 weeks)
  • Changes in disease activity measured by the Short Mayo Scale and Harvey Bradshaw Index(20 weeks)
  • Changes in hair cortisol levels(20 weeks)
  • Changes in General and GUT specific inflammatory markers(20 weeks)
  • Changes in medication requirements(20 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hugh Mulcahy

Professor Hugh Mulcahy

University College Dublin

研究点 (1)

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