Trial Details

Not Recruiting
Basic Information
Clinical ID c2623
Identifier ISRCTN71618461
Trial Title A Randomised Controlled Trial of supported online self-management for symptoms of fatigue, pain and urgency/incontinence in people with inflammatory bowel disease: the IBD-BOOST trial.
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Inflammatory Bowel Disease (IBD) Digestive System Inflammatory Bowel Disease (IBD)
Interventions Current intervention as of 19/07/2022: A pragmatic multi-centre two-arm, parallel group superiority RCT, with an internal pilot, of facilitator-supported online self-management versus care as usual to manage symptoms of fatigue, pain, and faecal urgency/incontinence in IBD. One baseline assessment and two assessments at 6 and 12 months after randomisation. Primary outcome: IBD-related quality of life and global rating of symptom relief at 6 months. This trial will compare a web-based programme, known as 'BOOST', for self-management of pain, fatigue and urgency/incontinence symptoms of IBD ('BOOST' is based on the principles of cognitive behavioural therapy with telephone and online messaging support) to standard care. The content has been developed by health psychologists to be interactive and tailored to patients' needs. BOOST includes 11 online sessions which can be viewed on computer, smart phone or tablet.). Sessions 1-6, are core transdiagnostic sessions to be completed by participants experiencing fatigue, pain and faecal urgency/incontinence. Based on a Cognitive Behavioural model of IBD symptoms, the core sessions cover topics around: understanding IBD symptoms, balancing activity and exercise, sleep hygiene, changing negative thoughts, coping with stress and emotions, and making the most of social support. Sessions 7-11 are symptom-specific sessions to be completed by participants experiencing or with a specific interest in fatigue, pain and faecal urgency/incontinence, respectively. The symptom specific sessions provide participants with more in-depth psychoeducation on the interaction between medical and psychosocial factors contributing to the severity and impact of IBD symptoms, together with practical tips and exercises on how to better manage them.
Participant Information
Sponsor London North West University Healthcare NHS Trust
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2023-03-24