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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03177044




Registration number
NCT03177044
Ethics application status
Date submitted
1/06/2017
Date registered
6/06/2017
Date last updated
19/03/2020

Titles & IDs
Public title
Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
Scientific title
Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
Secondary ID [1] 0 0
HREC/17/SVHM/92
Universal Trial Number (UTN)
Trial acronym
LIBERATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Diseases 0 0
Functional Gastrointestinal Disorders 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Behavioural treatment

Experimental: Behavioural treatment - 2 to 6 sessions of bowel behavioural training with a pelvic floor physiotherapist


Behaviour: Behavioural treatment
2 to 6 sessions of behavioural training with a pelvic floor physiotherapist

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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'
Timepoint [1] 0 0
At study completion, up to 12 weeks
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [2] 0 0
Change in St Marks Faecal Incontinence Score - Faecal incontinence symptom score ranging from 0-24
Timepoint [2] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [4] 0 0
Change in Short Form -36 (SF-36) score - Generic quality of life score
Timepoint [4] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [5] 0 0
Change in Hospital Anxiety and Depression Score (HADS) - 14 item questionnaire indicating presence of anxiety or depression
Timepoint [5] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [6] 0 0
Change in Brief Illness Perception Questionnaire score - 9 item questionnaire designed to assess cognitive and emotional perception of illness
Timepoint [6] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [7] 0 0
Change in Brief Cope score - 28 item questionnaire assessing patients' strategies for coping with stress
Timepoint [7] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [9] 0 0
Change in Euro-Qol (EQ-5D) - Generic quality of life tool to calculate quality adjusted life years (QALYs)
Timepoint [9] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
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..
Trial website
https://clinicaltrials.gov/show/NCT03177044
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael A Kamm, MBBS PhD
Address 0 0
St Vincent's Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications