Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease

Study Overview
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Brief Summary
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The primary aim of the project is to investigate whether a behavioural training programme improves troublesome bowel symptoms, that people with inflammatory bowel disease continue to have, despite their disease being controlled by medication. The other aim is to determine if there are factors which influence how well the training programme works. People attending an Inflammatory Bowel Disease clinic in a tertiary hospital, with bothersome bowel symptoms despite disease control, will be asked to join the study. This involves 2 to 6 sessions with a pelvic floor trained physiotherapist over a period of 6 months with further follow up at 12 months..

Detailed Description
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Inflammatory bowel diseases, chiefly Crohn's disease and ulcerative colitis, are chronic gastrointestinal (gut) conditions which tend to flare up some times and be quiet for other periods of time. They are usually controlled by medication. Inflammatory bowel disease is becoming more common, is usually diagnosed at a young age and is lifelong. A significant number of people with inflammatory bowel disease can have bowel symptoms which are bothersome even when the disease is quiescent. These symptoms include bowel urgency, frequent toileting, incontinence (leakage), constipation (infrequent bowel actions and/or difficulty emptying the bowel), abdominal pain, rectal pain or abdominal bloating. The symptoms can be very embarrassing or stressful, limiting activities and making life less enjoyable. People with these bowel symptoms, but without inflammatory bowel disease, respond to a type of therapy called behavioural treatment. We don't know yet if this treatment helps people with inflammatory bowel disease. Behavioural treatment involves learning about how the bowel works, better ways to manage bowel problems and specific exercises to improve bowel control. Specially trained pelvic floor physiotherapists provide 2-6 sessions, over 6 months, of behavioural treatment which may include the use of biofeedback techniques. Participants will be asked to complete surveys at the beginning and end of treatment and 12 months later. There are no recognised risks or unwanted side effects caused by behavioural treatment. The benefits are that people with inflammatory bowel disease will have an alternative low cost, low risk treatment which enables them to self-manage bowel symptoms and improve the quality of their life long term.

Official Title
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Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Diseases, Functional Gastrointestinal Disorders

Intervention / Treatment
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* Behavioral: Behavioural treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proven history of inflammatory bowel disease Clinical evidence of mild, stable disease or remission Mayo score ≤ 4, Harvey Bradshaw index ≤ 7 Bothersome lower bowel symptoms of any of the following: frequency, urgency, incontinence, difficult evacuation, constipation Exclusion Criteria: Significant medical or psychiatric comorbidity that in the opinion of the investigators would interfere with bowel function or adherence to the protocol Clinically significant narcotic or substance abuse that in the opinion of the investigators would interfere with bowel function or adherence to the protocol Recognised eating disorder Non- English speaking or illiterate Pregnancy Previous pelvic floor physiotherapy Current participant in another trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioural treatment<br>2 to 6 sessions of bowel behavioural training with a pelvic floor physiotherapist | Behavioral: Behavioural treatment<br>* 2 to 6 sessions of behavioural training with a pelvic floor physiotherapist<br>* Other names: Behavioural training programme;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient rating of improvement in symptoms | Proportion of patients achieving a rating of 'moderately improved' or 'substantially improved' on a 7 point Likert scale ranging from 'substantially worse' to 'substantially improved' | At study completion, up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Personal assessment of Constipation Symptoms (PAC-SYM) score | 12 constipation symptoms each rated on a 5 point Likert scale (0=symptom absent to 4 = very severe. | From baseline to study completion (up to 12 weeks) and at 1 year | 
| Change in St Marks Faecal Incontinence Score | Faecal incontinence symptom score ranging from 0-24 | From baseline to study completion (up to 12 weeks) and at 1 year | 
| Change in Inflammatory Bowel disease questionnaire (IBDQ) score | Disease specific quality of life instrument with 32 questions covering 4 domains - bowel symptoms, systemic symptoms, emotional function, social function | From baseline to study completion (up to 12 weeks) and at 1 year | 
| Change in Short Form -36 (SF-36) score | Generic quality of life score | From baseline to study completion (up to 12 weeks) and at 1 year | 
| Change in Hospital Anxiety and Depression Score (HADS) | 14 item questionnaire indicating presence of anxiety or depression | From baseline to study completion (up to 12 weeks) and at 1 year | 
| Change in Brief Illness Perception Questionnaire score | 9 item questionnaire designed to assess cognitive and emotional perception of illness | From baseline to study completion (up to 12 weeks) and at 1 year | 
| Change in Brief Cope score | 28 item questionnaire assessing patients' strategies for coping with stress | From baseline to study completion (up to 12 weeks) and at 1 year | 
| Change in Inflammatory Bowel Disease Self-efficacy scale (IBD-SES) | Disease specific scale with 29 items assessing how well patients believe they are managing their disease | From baseline to study completion (up to 12 weeks) and at 1 year | 
| Change in Euro-Qol (EQ-5D) | Generic quality of life tool to calculate quality adjusted life years (QALYs) | From baseline to study completion (up to 12 weeks) and at 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory bowel disease, pelvic floor exercise