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

November 10, 2022 updated by: Pakistan Institute of Living and Learning

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 72000
        • Abasi Shaheed Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: culturally adapted Cognitive Behavior Therapy
We will use The STreSS CBT manual developed by Schroder and his colleagues
Behavioral: Culturally adapted Cognitive Behavior Therapy for IBS
Culturally adapted Cognitive Behavior Therapy for IBS
NO_INTERVENTION: Treatment As Usual
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?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IBS-symptom severity scale
Time Frame: 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.
Change to baseline at 3rd Month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
IBS Rome III
Time Frame: Baseline
IBS symptoms will be recorded using Rome III Modular Questionnaire
Baseline
IBS quality of Life III
Time Frame: Baseline & 3rd Month
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
Time Frame: Baseline & 3rd Month
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)
Time Frame: Baseline & 3rd Month
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
Time Frame: 3rd month
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)
Time Frame: 3rd month
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)
Time Frame: Baseline and 3rd month
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)
Time Frame: Baseline
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)
Time Frame: Baseline and 3rd month
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)
Time Frame: Baseline
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
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pakistan Institute of Living and Learning

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karachi Medical and Dental College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Prof. Nusrat Husain, University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PILL-IBS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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