Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease (LIBERATE)

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..

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Functional Gastrointestinal Disorders
• Intervention / Treatment: Behavioral: Behavioural treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioural treatment; 2 to 6 sessions of bowel behavioural training with a pelvic floor physiotherapist	Behavioral: Behavioural treatment; 2 to 6 sessions of behavioural training with a pelvic floor physiotherapist; Other Names: Behavioural training programme

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mayo Score	Disease activity index for ulcerative colitis	From baseline to study completion (up to 12 weeks) and at 1 year
Change in Harvey Bradshaw Index	Disease activity index for Crohn's disease	From baseline to study completion (up to 12 weeks) and at 1 year
Patient rating of satisfaction	7 point Likert scale rating satisfaction	At study completion , up to 12 weeks
Change in pelvic floor muscle function	Measurement of pelvic floor muscle movement using transperineal ultrasound	From baseline to study completion (up to 12 weeks)

Collaborators and Investigators

• Sponsor: St Vincent's Hospital Melbourne
• Investigators: Study Director: Michael A Kamm, MBBS PhD, St Vincent's Hospital Melbourne

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Inflammatory bowel disease, pelvic floor exercise
• Additional Relevant MeSH Terms: Gastroenteritis; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases
• Other Study ID Numbers: HREC/17/SVHM/92

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