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

NCT ID: NCT03379064

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-30
• Study Completion Date: 2019-05-30

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

culturally adapted Cognitive Behavior Therapy

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

Group Type: EXPERIMENTAL

Culturally adapted Cognitive Behavior Therapy for IBS

Intervention Type: BEHAVIORAL

Culturally adapted Cognitive Behavior Therapy for IBS

Treatment As Usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Culturally adapted Cognitive Behavior Therapy for IBS

Culturally adapted Cognitive Behavior Therapy for IBS

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karachi Medical and Dental College

OTHER

Sponsor Role: collaborator

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Nusrat Husain

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

Abasi Shaheed Hospital

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

PILL-IBS-001

Identifier Type: -

Identifier Source: org_study_id