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

NCT03379064 | Completed DMC

• 1 other identifier: PILL-IBS-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, Low Income Country

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• IBS Rome III

  Baseline

• IBS quality of Life III

  Baseline & 3rd Month

• IBS pain scale-Pain Vigilance and Awareness Questionnaire

  Baseline & 3rd Month

• Brief Disability Questionnaire (BDQ)

  Baseline & 3rd Month

• Client Satisfaction Questionnaire

  3rd month

Study Arms (2)

culturally adapted Cognitive Behavior Therapy

EXPERIMENTAL

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

Behavioral: Culturally adapted Cognitive Behavior Therapy for IBS

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.

Interventions

Culturally adapted Cognitive Behavior Therapy for IBS BEHAVIORAL

Culturally adapted Cognitive Behavior Therapy for IBS

culturally adapted Cognitive Behavior Therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• Karachi Medical and Dental College: collaborator

Study Sites (1)

Abasi Shaheed Hospital

Karachi, Sindh, 72000, Pakistan

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Prof. Nusrat Husain

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: December 20, 2017
• Study Start: December 30, 2017
• Primary Completion: October 20, 2018
• Study Completion: May 30, 2019
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)