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Completed

NCT Number: NCT03177044

Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease

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..

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Functional Gastrointestinal Disorders Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioural treatment

Behavioral

2 to 6 sessions of behavioural training with a pelvic floor physiotherapist

Other names: Behavioural training programme

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

St Vincent's Hospital Melbourne

Other

Registry information

Acronym: LIBERATE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 6, 2017
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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