Randomised clinical trial: Psychological intervention improves work productivity and daily activity by reducing abdominal pain and fatigue in Crohn's disease

Background: Chronic abdominal pain and fatigue are characteristics of Crohn's disease (CD) and contribute to functional impairments. Aims: To examine whether CD-tailored cognitive-behavioural and mindfulness intervention (COBMINDEX) is effective in reducing abdominal pain and fatigue in patients with CD and whether changes in abdominal pain and fatigue mediate any beneficial effects of COBMINDEX on impairments in work productivity and daily activities. Methods: This is a secondary analysis of a parallel-group multicentre randomised controlled trial. Patients with mild-to-moderate CD (n = 142) were randomised into either intervention group receiving COBMINDEX, or control group receiving treatment-as-usual for 3 months followed by COBMINDEX. Complete data were collected from 120 patients (34.0 ± 10.7 years, 62.5% female, intervention = 60, control = 60). Analysis of covariance assessed group differences in 3-month follow-up scores, controlling for baseline scores. Multiple parallel mediation analysis assessed the proposed mechanisms for the entire sample. Results: The intervention group demonstrated significantly lower levels of abdominal pain (F = 17.46, p < 0.001, η²_p = 0.13), fatigue (F = 7.26, p = 0.008, η²_p = 0.06) and impairments at work (F = 4.82, p = 0.032, η²_p = 0.07) and daily activities (F = 6.26, p = 0.014, η²_p = 0.05), compared with treatment-as-usual. Moreover, changes in abdominal pain and fatigue significantly mediated the beneficial effects of COBMINDEX on patients' work productivity (b = −9.90, SE = 2.86, 95% CI: −16.11 to −4.94) and daily activities (b = −9.65, SE = 1.91, 95% CI: −13.77 to 6.35), independent of changes in disease activity. Conclusions: COBMINDEX is effective at reducing abdominal pain and fatigue in patients with CD, which in turn leads to improvement in functioning. Clinicians should incorporate screening for severe abdominal pain and fatigue and consider offering cognitive-behavioural and mindfulness training. ClinicalTrials.gov, Number: NCT05085925. Ministry of Health in Israel (https://my.health.gov.il/CliniTrials/Pages/MOH_2020-02-24_008721.aspx).