A randomised controlled trial of IBD-BOOST, a digital cognitive behavioural self-management programme for fatigue, pain, or faecal incontinence, or any combination of these symptoms, in people with inflammatory bowel disease

Problem

Even in clinical remission many people with inflammatory bowel disease (IBD) experience fatigue, pain and faecal incontinence (FI), impacting on their quality of life (QoL). IBD-BOOST is an interactive, digital online self-management intervention, based on a theoretically informed logic model and cognitive behavioural techniques, designed to treat these symptoms. We aimed to determine whether IBD-BOOST, alongside health care professional (HCP) support and care as usual (CAU), provided greater relief from IBD symptoms and an improvement in QoL compared with CAU alone.

Approach

A pragmatic multi-centre two-arm parallel group randomised controlled trial (RCT) recruiting adult participants from clinics and national registries. Eligible participants rated the impact of fatigue and/or pain and/or FI as ≥5 on a scale of 0-10 (where 10 = worst possible problem) and had no “red flag” symptoms. Those randomised to intervention received 6 months access to the IBD-BOOST programme (12-sessions) and a 30-minute telephone call plus weekly email messages for 3 months from a trained HCP. Dual primary outcomes were the UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and global rating of symptom relief (GRSR) at 6 months. Other secondary outcomes, were measured at 6 and 12 months. Complier-averaged causal effects (CACE), sensitivity and pre-specified subgroup analyses were conducted.

Findings

780 participants were randomised, 432 with Crohn’s disease, 348 with ulcerative colitis or other IBD; 520 (66.7%) were female, mean age 49 years. 57% of the intervention group completed a pre-defined minimum “dose” of 4 sessions (“compliers”). At 6 months both primary outcomes were similar between the BOOST and CAU arms (mean difference:-1.67, 95% CI:-4.17 to 0.83, p=0.19 for UK-IBDQ; mean difference:0.44, 95%CI:-0.56 to 1.43, p=0.39 for GRSR). FI score and EQ5D utility score (secondary outcomes) were significantly in favour of IBD-BOOST at 6 months, but pain and fatigue were no different. CACE analysis suggested that compliers were more likely to report better QoL than ‘would-be’ compliers in the CAU arm (p=0.03). Pre-planned subgroup analyses found IBD-BOOST was more effective in improving UK-IBDQ and GRSR at 6 months for participants who met criteria for irritable bowel syndrome (IBS) compared with participants who did not (p_interaction=0.015 and 0.046, respectively).

Consequences

This large RCT found that our digital IBD-BOOST self-management support intervention with HCP input did not improve quality of life (UK-IBDQ) or symptoms (GRSR) in patients with IBD and fatigue, pain, or FI symptoms (or any combination of these) compared to care as usual. Intervention arm participants reported less FI at 6 and 12 months compared to CAU participants. Intervention arm participants with IBS-like symptoms at baseline (overall 48% of those recruited) improved more than those without, suggesting the need for further effectiveness research on IBD-BOOST.