Mikocka-Walus Antonina, Bampton Peter, Hetzel David, Hughes Patrick, Esterman Adrian, Andrews Jane M
School of Nursing and Midwifery and Sansom Institute for Health Research, University of South Australia, Adelaide, Australia.
Department of Health Sciences, University of York, Area 4, ARRC Building, Heslington, YO10 5DD, UK.
BMC Gastroenterol. 2015 May 2;15:54. doi: 10.1186/s12876-015-0278-2.
Studies have demonstrated usefulness of cognitive-behavioural therapy (CBT) in managing distress in inflammatory bowel disease (IBD); however, few have focused on IBD course. The present trial aimed to investigate whether adding CBT to standard treatment prolongs remission in IBD in comparison to standard therapy alone.
A 2-arm parallel pragmatic randomised controlled trial (+CBT - standard care plus either face-to-face (F2F) or online CBT over 10 weeks versus standard care alone (SC)) was conducted with adult patients in remission. IBD remission at 12 months since baseline was the primary outcome measure while the secondary outcome measures were mental health status and quality of life (QoL). Linear mixed-effect models were used to compare groups on outcome variables while controlling for baseline.
Participants were 174 patients with IBD (90 +CBT, 84 SC). There was no difference in remission rates between groups, with similar numbers flaring at 12 months. Groups did not differ in anxiety, depression or coping at 6 or 12 months (p >0.05). When only participants classified as 'in need' (young, high baseline IBD activity, recently diagnosed; poor mental health) were examined in the post-hoc analysis (n = 74, 34 CBT and 40 controls), CBT significantly improved mental QoL (p = .034, d = .56) at 6 months. Online CBT group had a higher score on Precontemplation than the F2F group, which is consistent with less developed coping with IBD in the cCBT group (p = .045).
Future studies should direct psychological interventions to patients 'in need' and attempt to recruit larger samples to compensate for significant attrition when using online CBT.
The protocol was registered on 21/10/2009 with the Australian New Zealand Clinical Trials Registry (ID: ACTRN12609000913279).
研究已证明认知行为疗法（CBT）在管理炎症性肠病（IBD）患者的痛苦方面有用；然而，很少有研究关注IBD的病程。本试验旨在研究与单独的标准治疗相比，在标准治疗基础上加用CBT是否能延长IBD的缓解期。
对处于缓解期的成年患者进行了一项双臂平行实用随机对照试验（+CBT - 标准护理加为期10周的面对面（F2F）或在线CBT与单独的标准护理（SC））。自基线起12个月时的IBD缓解是主要结局指标，而次要结局指标是心理健康状况和生活质量（QoL）。使用线性混合效应模型在控制基线的同时比较各组的结局变量。
参与者为174例IBD患者（90例+CBT，84例SC）。两组之间的缓解率没有差异，12个月时病情复发的人数相似。两组在6个月或12个月时的焦虑、抑郁或应对方面没有差异（p>0.05）。在事后分析中，仅对被归类为“有需要”的参与者（年轻、基线IBD活动度高、近期诊断；心理健康状况差）进行检查时（n = 74，34例CBT和40例对照），CBT在6个月时显著改善了心理QoL（p = 0.034，d = 0.56）。在线CBT组在未考虑改变阶段的得分高于F2F组，这与在线CBT组中对IBD的应对能力发展较差一致（p = 0.045）。
未来的研究应将心理干预针对“有需要”的患者，并尝试招募更大的样本以弥补使用在线CBT时的显著损耗。
该方案于2009年10月21日在澳大利亚新西兰临床试验注册中心注册（注册号：ACTRN12609000913279）。
