Inflammatory Bowel DiseasesLIBERATENCT03177044
Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
A study testing Behavioural treatment in people with Inflammatory Bowel Diseases and Functional Gastrointestinal Disorders, run by St Vincent's Hospital Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Functional Gastrointestinal Disorders
- What is being tested?
- Behavioural treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jun 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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..
Read the 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.
- Being tested
- Behavioural treatment
- Keywords
- Inflammatory bowel disease, pelvic floor exercise
- Medical subject headings
- Inflammatory Bowel Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural treatmentBehavioural
Also called Behavioural training programme
2 to 6 sessions of behavioural training with a pelvic floor physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Behavioural treatment | Experimental | 2 to 6 sessions of bowel behavioural training with a pelvic floor physiotherapist Receives: Behavioral: Behavioural treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: At study completion, up to 12 weeks
Secondary outcomes (9)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: From baseline to study completion (up to 12 weeks) and at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Jun 2017
- Primary completion30 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Khera, St Vincent's Hospital Melbourne
- Investigators
- Michael A Kamm, MBBS PhD, Study director, St Vincent's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177044
- Sponsor's protocol ID
- HREC/17/SVHM/92
- Acronym
- LIBERATE
- Status last verified
- Apr 2023
- First submitted
- 1 Jun 2017
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03177044
- Acronym / sponsor ID
- LIBERATE / HREC/17/SVHM/92
- Keywords
- Inflammatory bowel disease, pelvic floor exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- St Vincent's Hospital MelbourneUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Behavioural treatment | Experimental | Behavioral: Behavioural treatment2 to 6 sessions of bowel behavioural training with a pelvic floor physiotherapist |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural treatmentAlso: Behavioural training programme2 to 6 sessions of behavioural training with a pelvic floor physiotherapist | Behavioural | Behavioural treatment |
Primary outcome
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'
9 secondary outcomes
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
Change in St Marks Faecal Incontinence Score
Time frame: From baseline to study completion (up to 12 weeks) and at 1 year
Change in Inflammatory Bowel disease questionnaire (IBDQ) score
Time frame: From baseline to study completion (up to 12 weeks) and at 1 year
Change in Short Form -36 (SF-36) score
Time frame: From baseline to study completion (up to 12 weeks) and at 1 year
Change in Hospital Anxiety and Depression Score (HADS)
Time frame: From baseline to study completion (up to 12 weeks) and at 1 year
Change in Brief Illness Perception Questionnaire score
Time frame: From baseline to study completion (up to 12 weeks) and at 1 year
Change in Brief Cope score
Time frame: From baseline to study completion (up to 12 weeks) and at 1 year
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
Change in Euro-Qol (EQ-5D)
Time frame: From baseline to study completion (up to 12 weeks) and at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Kamm, MBBS PhD study director
St Vincent's Hospital Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural treatment in people with Inflammatory Bowel Diseases and Functional Gastrointestinal Disorders, run by St Vincent's Hospital Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient rating of improvement in symptoms (time frame: At study completion, up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.