Randomised clinical trial: Psychological intervention improves work productivity and daily activity by reducing abdominal pain and fatigue in Crohn's disease.
Study Goal
The researchers aimed to determine whether a CD-tailored cognitive-behavioural and mindfulness intervention (COBMINDEX) effectively reduces abdominal pain and fatigue in patients with Crohn's disease and whether these changes mediate improvements in work productivity and daily activities.
Results Summary
The intervention group showed significantly lower abdominal pain and fatigue compared to controls, leading to improved functioning. The study concluded that COBMINDEX is effective for reducing these symptoms in Crohn's disease patients.
Population
Patients with mild-to-moderate Crohn's disease (n=120, 34.0±10.7 years, 62.5% female).
Effective Dosage
Not specified
Duration
3 months
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
CD-tailored cognitive-behavioural and mindfulness intervention (COBMINDEX) | decrease | abdominal pain | patients with mild-to-moderate CD | - | demonstrated significantly lower levels | #1 |
CD-tailored cognitive-behavioural and mindfulness intervention (COBMINDEX) | decrease | fatigue | patients with mild-to-moderate CD | - | demonstrated significantly lower levels | #2 |
CD-tailored cognitive-behavioural and mindfulness intervention (COBMINDEX) | increase | functioning | patients with CD | - | leads to improvement | #3 |
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, η 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).