A randomised controlled trial of a brief self-help intervention for post infectious irritable bowel syndrome (IBS)

Completed

• Conditions: Post infectious irritable bowel syndrome (IBS); Oral and Gastrointestinal - Studies of infection and infectious agents

• Registration Number: ACTRN12605000286640
• Lead Sponsor: Dr Rona Moss-Morris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

(a) a diagnosis of IBS based on Rome I modified and/or Rome II criteria. (b) a diagnosis of IBS subsequent to an episode of gastroenteritis (c) between the ages of 18-70 (d) primary care attendees in the greater Auckland area.

Exclusion Criteria

(a) Patients who have another medical condition that may affect their symptoms or preclude a diagnosis of IBS such as previous bowel surgery or a malignancy, ceoliac disease, inflammatory bowel disease, or obstructive bowel pathology (b) Patients who have any serious psychological disorders for whom treatment would be inappropriate including psychotic disorders or active substance abuse. (c). Non-English speakers and people who are unable to read and write English. (d) Should any participants alter their medication during this time period, or begin a course of anti-depressant medication their data will not be included in the final analysis. (e) Inclusion in another treatment trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Subjects Global Assessment of Relief (Muller-Lissner et al. (2003) which has been developed as a primary assessment of outcome in clinical studies of IBS with the intention of identifying responders to therapy[Measured at the end of treatment, and 3 and 6 months follow-up];The Irritable Bowel Symptom Severity Scoring System (Francis et al., 1997) which provides an indication of bowel symptom severity[Measured at baseline, end of treatment, 3 and 6 months follow-up]

Secondary Outcome Measures

Name	Time	Method
The Work and Social Adjustment Scale (WSAS) (Mundt et al 2002), is used to measure the impact of IBS on the person’s day to day life.[Measured at baseline, end of treatment, 3 and 6 months follow–up.];The Hospital Anxiety and Depression scale (HAD) (Zigmond 1983) is used to assess the degree of anxiety and depression.[Measured at baseline, end of treatment, 3 and 6 months follow–up.]