Clinical trial NCT03379064: Culturally Adapted Psychological Intervention for the Management of Irritable Bowel Syndrome (IBS)
Official title: Exploratory Randomised Controlled Trial of a Culturally Adapted Psychological Intervention for the Management of Irritable Bowel Syndrome (IBS) in a Low-income Country
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome, Low Income Country
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: Karachi Medical and Dental College
First posted: 2017-12-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: IBS-symptom severity scale
timeFrame: Change to baseline at 3rd Month
Secondary outcomes:
measure: IBS Rome III
timeFrame: Baseline
measure: IBS quality of Life III
timeFrame: Baseline & 3rd Month
measure: IBS pain scale-Pain Vigilance and Awareness Questionnaire
timeFrame: Baseline & 3rd Month
measure: Brief Disability Questionnaire (BDQ)
timeFrame: Baseline & 3rd Month
measure: Client Satisfaction Questionnaire
timeFrame: 3rd month
measure: Global Improvement Scale (GIS)
timeFrame: 3rd month
measure: EQ-5D (EuroQol-5 Dimensions)
timeFrame: Baseline and 3rd month
measure: Mini International neuropsychiatric Interview (MINI)
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and 3rd month
measure: The Illness Perception Questionnaire (IPQ)
timeFrame: Baseline
measure: Short Explanatory Model Interview
timeFrame: Baseline
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Abasi Shaheed Hospital
state: Sindh
Study officials:
affiliation: University of Manchester
name: Prof. Nusrat Husain
role: PRINCIPAL_INVESTIGATOR
References: