Affiliation:
1. Department of Social Work Ben‐Gurion University of the Negev Beer‐Sheva Israel
2. Department of Gastroenterology and Hepatology, Soroka Medical Center Beer‐Sheva Israel
3. Department of Public Health Ben‐Gurion University of the Negev Beer‐Sheva Israel
4. Department of Health Systems Management Ben‐Gurion University of the Negev Beer‐Sheva Israel
5. Department of Microbiology, Immunology and Genetics Ben‐Gurion University of the Negev Beer‐Sheva Israel
6. Division of Clinical Medicine, Faculty of Health Sciences Ben‐Gurion University of the Negev Beer‐Sheva Israel
Abstract
SummaryBackgroundChronic abdominal pain and fatigue are characteristics of Crohn's disease (CD) and contribute to functional impairments.AimsTo 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.MethodsThis 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.ResultsThe intervention group demonstrated significantly lower levels of abdominal pain (F = 17.46, p < 0.001, η2p = 0.13), fatigue (F = 7.26, p = 0.008, η2p = 0.06) and impairments at work (F = 4.82, p = 0.032, η2p = 0.07) and daily activities (F = 6.26, p = 0.014, η2p = 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.ConclusionsCOBMINDEX 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).
Funder
Leona M. and Harry B. Helmsley Charitable Trust
Subject
Pharmacology (medical),Gastroenterology,Hepatology