Culturally Adapted Psychological Intervention for the Management of Irritable Bowel Syndrome (IBS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Culturally adapted Cognitive Behavior Therapy for IBS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with ROME 111 diagnoses of IBS Between the age bracket of 18 to 55 years. willing to give written informed consent. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: culturally adapted Cognitive Behavior Therapy<br>We will use The STreSS CBT manual developed by Schroder and his colleagues | Behavioral: Culturally adapted Cognitive Behavior Therapy for IBS<br>* Culturally adapted Cognitive Behavior Therapy for IBS<br>|
| No Intervention: Treatment As Usual<br>The Treatment As Usual (TAU) group will receive regular treatment they have been receiving already as prescribed by the physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS-symptom severity scale | 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. | Change to baseline at 3rd Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS Rome III | IBS symptoms will be recorded using Rome III Modular Questionnaire | Baseline | 
| IBS quality of Life III | The IBS-Qol is a 34-item measure of the degree to which IBS symptoms affect lives (5-point scale) The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. There are also eight subscale scores for the IBS-QOL (Dysphoria, Interference with Activity, Body Image, Health Worry, Food Avoidance, Social Reaction, Sexual, Relationships). | Baseline & 3rd Month | 
| IBS pain scale-Pain Vigilance and Awareness Questionnaire | This 16-item measure will be used to assess pain awareness on a 0-5 point scale, tapping into constructs of awareness, vigilance, preoccupation, and observation of pain. Participants will rate a number of statements from 0 (Never) to 5 (Always) such as; I keep track of my pain level. | Baseline & 3rd Month | 
| Brief Disability Questionnaire (BDQ) | Disability will be assessed using the cross-culturally validated BDQ, which includes 6 items from the SF-36, asking subjects whether they had been limited in various everyday activities during the last month and four ques-tions concerning daily functioning. Total scores across items 1-6 are considered to indicate 'moderate' and 'severe' disability for score ranges 8-13 and 14-22 respectively. Additionally, participants were asked to estimate how many days over the prior few weeks they were unable to carry out their usual daily activities thus providing an estimate of 'functional disability'. | Baseline & 3rd Month | 
| Client Satisfaction Questionnaire | CSQ is an 8-item scale that shall be used to measure satisfaction with the treatment received. CSQ is an 8-item scale that shall be used to measure satisfaction with the treatment received.This scale is scored by summing the individual item scores to produce a range of 8 to 32, with high scores indicating greater satisfaction | 3rd month | 
| Global Improvement Scale (GIS) | Global Improvement will be assessed with the Global Improvement Scale (GIS).This scale asks participants Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been from (1) = substantially worse, to (7) = substantially improved. Global improvement is noted for patients endorsing moderately or substantially improved status. | 3rd month | 
| EQ-5D (EuroQol-5 Dimensions) | It is a generic measure in which health status is defined in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.Each dimension has three qualifying levels of response roughly corresponding to 'no problems', 'some difficulties/problems', and 'extreme difficulties. The scale has been already used in Pakistan. | Baseline and 3rd month | 
| Mini International neuropsychiatric Interview (MINI) | Mini International neuropsychiatric Interview (MINI) will be used as a psychiatric diagnostic instrument. It is a short structured diagnostic interview, for DSM-IV and ICD- 10 psychiatric disorders. With an administration time of approximately 15 minutes, it was designed to meet the need for a short but accurate structured psychiatric interview for multicenter clinical trials and epidemiology studies and to be used as a first step in outcome tracking in non research clinical settings. | Baseline | 
| Hospital Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression Scale (HADS) shall be used to assess anxiety and depression. Score 0-7 is considered as (NORMAL) 8 to 10 (Borderline Normal) 11-14 (Moderate), 15 to 21 (Severe) for sub scale separately | Baseline and 3rd month | 
| The Illness Perception Questionnaire (IPQ) | The IPQ will be used to assess the cognitive representations of illness. The Identity scale is comprised of 12 core symptom items that the patient is asked to rate for frequency on a four point scale ranging from all of the time to never. There are total 26 items in rest of the 4 scales and are rated by the patient on a five point scale ranging from Strongly Disagree to Strongly Agree (scored 1 to 5) | Baseline | 
| Short Explanatory Model Interview | SEMI is a short interview that will be administered to elicit the explanatory models.The interview explores the participants' cultural background, nature of presenting problem, help seeking behaviours, interaction with physician and beliefs related to illness. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Low Income Country