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

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ClinicalTrials.gov Identifier: NCT03177044
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Angela Khera, St Vincent's Hospital Melbourne

Brief Summary:

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..


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Functional Gastrointestinal Disorders Behavioral: Behavioural treatment Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective cohort
Masking: None (Open Label)
Masking Description: All assessments are conducted by an assessor not providing the intervention
Primary Purpose: Treatment
Official Title: Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

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 Name: Behavioural training programme




Primary Outcome Measures :
  1. Patient rating of improvement in symptoms [ Time Frame: At study completion, up to 12 weeks ]
    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'


Secondary Outcome Measures :
  1. Change in Personal assessment of Constipation Symptoms (PAC-SYM) score [ Time Frame: From baseline to study completion (up to 12 weeks) and at 1 year ]
    12 constipation symptoms each rated on a 5 point Likert scale (0=symptom absent to 4 = very severe.

  2. Change in St Marks Faecal Incontinence Score [ Time Frame: From baseline to study completion (up to 12 weeks) and at 1 year ]
    Faecal incontinence symptom score ranging from 0-24

  3. Change in Inflammatory Bowel disease questionnaire (IBDQ) score [ Time Frame: From baseline to study completion (up to 12 weeks) and at 1 year ]
    Disease specific quality of life instrument with 32 questions covering 4 domains - bowel symptoms, systemic symptoms, emotional function, social function

  4. Change in Short Form -36 (SF-36) score [ Time Frame: From baseline to study completion (up to 12 weeks) and at 1 year ]
    Generic quality of life score

  5. Change in Hospital Anxiety and Depression Score (HADS) [ Time Frame: From baseline to study completion (up to 12 weeks) and at 1 year ]
    14 item questionnaire indicating presence of anxiety or depression

  6. Change in Brief Illness Perception Questionnaire score [ Time Frame: From baseline to study completion (up to 12 weeks) and at 1 year ]
    9 item questionnaire designed to assess cognitive and emotional perception of illness

  7. Change in Brief Cope score [ Time Frame: From baseline to study completion (up to 12 weeks) and at 1 year ]
    28 item questionnaire assessing patients' strategies for coping with stress

  8. Change in Inflammatory Bowel Disease Self-efficacy scale (IBD-SES) [ Time Frame: From baseline to study completion (up to 12 weeks) and at 1 year ]
    Disease specific scale with 29 items assessing how well patients believe they are managing their disease

  9. Change in Euro-Qol (EQ-5D) [ Time Frame: From baseline to study completion (up to 12 weeks) and at 1 year ]
    Generic quality of life tool to calculate quality adjusted life years (QALYs)


Other Outcome Measures:
  1. Change in Mayo Score [ Time Frame: From baseline to study completion (up to 12 weeks) and at 1 year ]
    Disease activity index for ulcerative colitis

  2. Change in Harvey Bradshaw Index [ Time Frame: From baseline to study completion (up to 12 weeks) and at 1 year ]
    Disease activity index for Crohn's disease

  3. Patient rating of satisfaction [ Time Frame: At study completion , up to 12 weeks ]
    7 point Likert scale rating satisfaction

  4. Change in pelvic floor muscle function [ Time Frame: From baseline to study completion (up to 12 weeks) ]
    Measurement of pelvic floor muscle movement using transperineal ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177044


Contacts
Contact: Angela J Khera, BAppSc +61 3 419110756 angela.khera@svha.org.au
Contact: Amy Wilson-O'Brien, BSc PhD +61 3 9231 2316 amy.wilson-obrien@svha.org.au

Locations
Australia, Victoria
St Vincent's Hospital Recruiting
Fitzroy, Victoria, Australia, 3065
Contact: Angela J Khera, BAppSc    +61 419 110 756    angela.khera@svha.org.au   
Contact: Amy Wilson-O'Brien, BSc, PhD    + 61 3 9231 2316    amy.wilson-obrien@svha.org.au   
Sponsors and Collaborators
St Vincent's Hospital Melbourne
Investigators
Study Director: Michael A Kamm, MBBS PhD St Vincent's Hospital Melbourne

Responsible Party: Angela Khera, Principal Investigator, St Vincent's Hospital Melbourne
ClinicalTrials.gov Identifier: NCT03177044     History of Changes
Other Study ID Numbers: HREC/17/SVHM/92
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Angela Khera, St Vincent's Hospital Melbourne:
Inflammatory bowel disease, pelvic floor exercise

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Digestive System Diseases
Gastrointestinal Diseases
Gastroenteritis