随机临床试验：心理干预通过减轻克罗恩病患者的腹痛和疲劳，提高工作生产力和日常活动能力。
Randomised clinical trial: Psychological intervention improves work productivity and daily activity by reducing abdominal pain and fatigue in Crohn's disease.
机构信息
Department of Social Work, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Department of Gastroenterology and Hepatology, Soroka Medical Center, Beer-Sheva, Israel.
出版信息
Aliment Pharmacol Ther. 2023 Apr;57(8):861-871. doi: 10.1111/apt.17399. Epub 2023 Feb 2.
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 = 0.13), fatigue (F = 7.26, p = 0.008, η = 0.06) and impairments at work (F = 4.82, p = 0.032, η = 0.07) and daily activities (F = 6.26, p = 0.014, η = 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).
背景
慢性腹痛和疲劳是克罗恩病（CD）的特征，会导致功能障碍。
目的
研究针对 CD 的认知行为和正念干预（COBMINDEX）是否能有效减轻 CD 患者的腹痛和疲劳，以及腹痛和疲劳的变化是否能介导 COBMINDEX 对工作生产力和日常活动受损的任何有益影响。
方法
这是一项平行组多中心随机对照试验的二次分析。轻度至中度 CD 患者（n=142）被随机分为干预组（接受 COBMINDEX）或对照组（接受常规治疗 3 个月后再接受 COBMINDEX）。120 名患者（34.0±10.7 岁，62.5%女性，干预组=60，对照组=60）完成了完整的数据收集。协方差分析评估了 3 个月随访时组间差异，控制了基线评分。多元平行中介分析评估了整个样本的拟议机制。
结果
干预组的腹痛（F=17.46，p<0.001，η ²=0.13）、疲劳（F=7.26，p=0.008，η ²=0.06）和工作（F=4.82，p=0.032，η ²=0.07）和日常活动（F=6.26，p=0.014，η ²=0.05）的评分明显低于常规治疗组。此外，腹痛和疲劳的变化显著介导了 COBMINDEX 对患者工作生产力（b=-9.90，SE=2.86，95%CI：-16.11 至-4.94）和日常活动（b=-9.65，SE=1.91，95%CI：-13.77 至 6.35）的有益影响，独立于疾病活动的变化。
结论
COBMINDEX 可有效减轻 CD 患者的腹痛和疲劳，进而改善其功能。临床医生应进行严重腹痛和疲劳的筛查，并考虑提供认知行为和正念训练。
临床试验
gov，编号：NCT05085925。以色列卫生部（https://my.health.gov.il/CliniTrials/Pages/MOH_2020-02-24_008721.aspx）。
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