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

P

Pakistan Institute of Living and Learning

Status

Completed

Conditions

Irritable Bowel Syndrome

Treatments

Behavioral: Culturally adapted Cognitive Behavior Therapy for IBS

Study type

Interventional

Funder types

Other

Identifiers

NCT03379064
PILL-IBS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

45 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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