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Group cognitive behavioural therapy (GCBT) versus treatment as usual (TAU) in the treatment of irritable bowel syndrome (IBS): a study protocol for a randomized controlled trial.

团体认知行为疗法 (GCBT) 与常规治疗 (TAU) 治疗肠易激综合征 (IBS): 一项随机对照试验的研究方案。

  • 影响因子:2.76
  • DOI:10.1186/s12876-020-1157-z
  • 作者列表:"Kikuchi S","Oe Y","Sasaki Y","Ishii H","Ito Y","Horikoshi M","Sozu T","Seno H","Furukawa TA
  • 发表时间:2020-02-04
Abstract

BACKGROUND:Irritable bowel syndrome (IBS) is a common disease that affects the quality of life (QOL) and social functioning of sufferers. Visceral anxiety is currently considered a key factor in the onset and exacerbation of IBS, and cognitive-behavioural therapy (CBT) targeting visceral anxiety is thought to be effective. However, access to CBT is limited due to the lack of trained therapists, the substantial time required for therapy and the associated costs. Group CBT (GCBT) may solve some of these problems. We have therefore planned this trial to examine the efficacy of GCBT for IBS. METHODS:The trial is a two-armed, parallel group, open label, stratified block randomized superiority trial. The study group will consist of 112 participants (aged 18-75 years) with IBS (Rome-III or IV criteria). Participants will be randomly allocated 1:1 to (i) the intervention group: ten-week GCBT plus treatment as usual (TAU) or (ii) the control group: waiting list (WL) plus TAU. The co-primary outcomes are the change in IBS severity or disease-specific quality of life from baseline to week 13 which is 1 month after the end of treatment. The efficacy of GCBT for IBS will be examined through mixed-effects repeated-measures analysis. DISCUSSION:GCBT, if found effective, can address the issues of the shortage of therapists as well as the time required and the costs associated with individual CBT. Clinically, the findings will help make effective CBT programmes accessible to a large number of distressed IBS patients at lower costs. Theoretically, the results will clarify the relationship between IBS and psychological stress and will help elucidate the underlying mechanisms of IBS. TRIAL REGISTRATION:UMIN, CTR-UMIN000031710. Registered on March 13, 2018.

摘要

背景: 肠易激综合征 (IBS) 是影响患者生活质量和社会功能的常见疾病。内脏焦虑目前被认为是 IBS 发病和加重的关键因素,针对内脏焦虑的认知行为疗法 (CBT) 被认为是有效的。然而,由于缺乏训练有素的治疗师、治疗所需的大量时间和相关费用,CBT 的获取受到限制。组 CBT (GCBT) 可能会解决其中的一些问题。因此,我们计划进行这项试验,以检查 GCBT 对 IBS 的疗效。 方法: 本试验为两支武装、平行组、开放标签、分层区组随机优势试验。研究组将由 112 名符合 IBS (罗马-III 或 IV 标准) 的参与者 (年龄 18-75 岁) 组成。参与者将被随机分配到 1:1 (i) 干预组: 10 周 GCBT 加治疗照常 (TAU) 或 (ii) 对照组: 等候名单 (WL) 加上 TAU。共同主要结局是 IBS 严重程度或疾病特异性生活质量从基线到第 13 周 (治疗结束后 1 个月) 的变化。GCBT 对 IBS 的疗效将通过混合效应重复测量分析来检查。 讨论: GCBT 如果被发现有效,可以解决治疗师短缺的问题,以及所需的时间和与个人 CBT 相关的费用。临床上,这些发现将有助于有效的 CBT 方案以较低的成本提供给大量心疼的 IBS 患者。从理论上讲,该结果将阐明 IBS 与心理应激的关系,并将有助于阐明 IBS 的潜在机制。 试用注册: UMIN,CTR-UMIN000031710。2018年3月13日注册。

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作者列表:["Ronchetti S","Gentili M","Ricci E","Migliorati G","Riccardi C"]

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关键词: GILZ IBD 自身免疫 炎症
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