Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease (LIBERATE)
Primary Purpose
Inflammatory Bowel Diseases, Functional Gastrointestinal Disorders
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Behavioural treatment
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Inflammatory bowel disease, pelvic floor exercise
Eligibility 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
Sites / Locations
- St Vincent's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Behavioural treatment
Arm Description
2 to 6 sessions of bowel behavioural training with a pelvic floor physiotherapist
Outcomes
Primary Outcome Measures
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'
Secondary Outcome Measures
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.
Change in St Marks Faecal Incontinence Score
Faecal incontinence symptom score ranging from 0-24
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
Change in Short Form -36 (SF-36) score
Generic quality of life score
Change in Hospital Anxiety and Depression Score (HADS)
14 item questionnaire indicating presence of anxiety or depression
Change in Brief Illness Perception Questionnaire score
9 item questionnaire designed to assess cognitive and emotional perception of illness
Change in Brief Cope score
28 item questionnaire assessing patients' strategies for coping with stress
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
Change in Euro-Qol (EQ-5D)
Generic quality of life tool to calculate quality adjusted life years (QALYs)
Full Information
NCT ID
NCT03177044
First Posted
June 1, 2017
Last Updated
April 11, 2023
Sponsor
St Vincent's Hospital Melbourne
1. Study Identification
Unique Protocol Identification Number
NCT03177044
Brief Title
Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
Acronym
LIBERATE
Official Title
Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Vincent's Hospital Melbourne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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..
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Functional Gastrointestinal Disorders
Keywords
Inflammatory bowel disease, pelvic floor exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort
Masking
None (Open Label)
Masking Description
All assessments are conducted by an assessor not providing the intervention
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioural treatment
Arm Type
Experimental
Arm Description
2 to 6 sessions of bowel behavioural training with a pelvic floor physiotherapist
Intervention Type
Behavioral
Intervention Name(s)
Behavioural treatment
Other Intervention Name(s)
Behavioural training programme
Intervention Description
2 to 6 sessions of behavioural training with a pelvic floor physiotherapist
Primary Outcome Measure Information:
Title
Patient rating of improvement in symptoms
Description
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'
Time Frame
At study completion, up to 12 weeks
Secondary Outcome Measure Information:
Title
Change in Personal assessment of Constipation Symptoms (PAC-SYM) score
Description
12 constipation symptoms each rated on a 5 point Likert scale (0=symptom absent to 4 = very severe.
Time Frame
From baseline to study completion (up to 12 weeks) and at 1 year
Title
Change in St Marks Faecal Incontinence Score
Description
Faecal incontinence symptom score ranging from 0-24
Time Frame
From baseline to study completion (up to 12 weeks) and at 1 year
Title
Change in Inflammatory Bowel disease questionnaire (IBDQ) score
Description
Disease specific quality of life instrument with 32 questions covering 4 domains - bowel symptoms, systemic symptoms, emotional function, social function
Time Frame
From baseline to study completion (up to 12 weeks) and at 1 year
Title
Change in Short Form -36 (SF-36) score
Description
Generic quality of life score
Time Frame
From baseline to study completion (up to 12 weeks) and at 1 year
Title
Change in Hospital Anxiety and Depression Score (HADS)
Description
14 item questionnaire indicating presence of anxiety or depression
Time Frame
From baseline to study completion (up to 12 weeks) and at 1 year
Title
Change in Brief Illness Perception Questionnaire score
Description
9 item questionnaire designed to assess cognitive and emotional perception of illness
Time Frame
From baseline to study completion (up to 12 weeks) and at 1 year
Title
Change in Brief Cope score
Description
28 item questionnaire assessing patients' strategies for coping with stress
Time Frame
From baseline to study completion (up to 12 weeks) and at 1 year
Title
Change in Inflammatory Bowel Disease Self-efficacy scale (IBD-SES)
Description
Disease specific scale with 29 items assessing how well patients believe they are managing their disease
Time Frame
From baseline to study completion (up to 12 weeks) and at 1 year
Title
Change in Euro-Qol (EQ-5D)
Description
Generic quality of life tool to calculate quality adjusted life years (QALYs)
Time Frame
From baseline to study completion (up to 12 weeks) and at 1 year
Other Pre-specified Outcome Measures:
Title
Change in Mayo Score
Description
Disease activity index for ulcerative colitis
Time Frame
From baseline to study completion (up to 12 weeks) and at 1 year
Title
Change in Harvey Bradshaw Index
Description
Disease activity index for Crohn's disease
Time Frame
From baseline to study completion (up to 12 weeks) and at 1 year
Title
Patient rating of satisfaction
Description
7 point Likert scale rating satisfaction
Time Frame
At study completion , up to 12 weeks
Title
Change in pelvic floor muscle function
Description
Measurement of pelvic floor muscle movement using transperineal ultrasound
Time Frame
From baseline to study completion (up to 12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Kamm, MBBS PhD
Organizational Affiliation
St Vincent's Hospital Melbourne
Official's Role
Study Director
Facility Information:
Facility Name
St Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
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