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临床试验/NCT03379064
NCT03379064已完成不适用

Exploratory Randomised Controlled Trial of a Culturally Adapted Psychological Intervention for the Management of Irritable Bowel Syndrome (IBS) in a Low-income Country

Pakistan Institute of Living and Learning1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年12月30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
45
试验地点
1
主要终点
IBS-symptom severity scale

研究概览

简要总结

Irritable bowel syndrome (IBS) is a highly prevalent functional bowel disorder routinely encountered by healthcare providers although it's not life-threatening, this chronic disorder has ability to reduce patients' quality of life and imposes a significant economic burden to the healthcare system.Despite the high prevalence of IBS and its association with disability and adverse effect on health related quality of life we are not aware of any published trial of psychological intervention for IBS from Pakistan. We aim to test the feasibility and acceptability of culturally adapted Cognitive Behaviour Therapy (CBT) for the management of IBS in Karachi, Pakistan compared to treatment as usual.

详细描述

A systematic review suggested no overall difference in the rates of IBS in East and West . In a population based study from Pakistan. Prevalence of IBS was assessed using Rome II criteria in relation to psychological distress, disability and life events in men and women separately. The prevalence of Rome II IBS was 13.3% which was higher than most population-based studies in Asia using Rome II criteria and similar to reports from Turkey and Malaysia.The findings also suggest equal sex ratio of IBS in urban Pakistan which may be because of the close association between marked distress and IBS in men similar to that found in women in the west.The results indicated that diarrhea-predominant IBS was associated with less disability compared to the constipation-predominant IBS which was associated with marked disability. This might be explained by the explanatory models; constipation is considered harmful as toxins or other harmful substances are retained within the body whereas diarrhea is not considered harmful as any toxins etc are removed from the body. Distress and life events contributed independently to high disability. In psychological treatments there is an assumption that there are some critical features which need to be addressed in the treatment process such as stress and anxiety; it also suggests that stress has a major role in increasing IBS symptoms as well as stress reactivity which results in IBS symptoms. The goal of cognitive-behavioral treatments is to increase awareness regarding the association between stress, thoughts, and IBS symptoms, it is important to identify and modify cognitive appraisals and to change depressive and/or anxiety-based schema. These interventions play a major role in decreasing IBS symptoms severity and associated anxiety and depression when compared to no treatment or standard medical care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals with ROME 111 diagnoses of IBS
  • •Between the age bracket of 18 to 55 years.
  • •willing to give written informed consent.

排除标准

  • •Individuals with atypical symptoms (rectal bleeding, anaemia or unexplained weightloss).
  • •Diagnosis of inflammatory bowel disease, celiac disease or colon cancer.
  • •Pregnant or breast feeding.
  • •History of drug, alcohol, or chemical abuse within 6 months prior to screening.
  • •Metabolic dysfunction, serious physical examination finding, or clinical laboratory finding giving reasonable suspicion that it might affect the interpretation of the re-sults or render the patient at high risk from treatment complication

研究组 & 干预措施

culturally adapted Cognitive Behavior Therapy

Experimental

We will use The STreSS CBT manual developed by Schroder and his colleagues

干预措施: Culturally adapted Cognitive Behavior Therapy for IBS (Behavioral)

Treatment As Usual

No Intervention

The Treatment As Usual (TAU) group will receive regular treatment they have been receiving already as prescribed by the physician.

结局指标

主要结局

IBS-symptom severity scale

时间窗: Change to baseline at 3rd Month

The score of this system is based on five items (severity and duration of pain, abdominal distension, bowel satisfaction, and interference with life in general) and uses visual analogue scales. Patients can be categorized as having mild (75-175), moderate (175-300), or severe (\>300) IBS.

次要结局

  • IBS Rome III(Baseline)
  • Global Improvement Scale (GIS)(3rd month)
  • Hospital Anxiety and Depression Scale (HADS)(Baseline and 3rd month)
  • Brief Disability Questionnaire (BDQ)(Baseline & 3rd Month)
  • The Illness Perception Questionnaire (IPQ)(Baseline)
  • Short Explanatory Model Interview(Baseline)
  • IBS quality of Life III(Baseline & 3rd Month)
  • IBS pain scale-Pain Vigilance and Awareness Questionnaire(Baseline & 3rd Month)
  • Client Satisfaction Questionnaire(3rd month)
  • Mini International neuropsychiatric Interview (MINI)(Baseline)
  • EQ-5D (EuroQol-5 Dimensions)(Baseline and 3rd month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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