The Irritable Bowel Syndrome Outcome Study (IBSOS): Rationale and design of a randomized, placebo-controlled trial with 12 month follow up of self- versus clinician-administered CBT for moderate to severe irritable bowel syndrome
The Irritable Bowel Syndrome Outcome Study (IBSOS): Rationale and design of a randomized, placebo-controlled trial with 12 month follow up of self- versus clinician-administered CBT for moderate to severe irritable bowel syndrome
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DOI：
10.1016/j.cct.2012.07.013
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发表时间：
2012-11-01
影响因子：
2.2
通讯作者：
Byroads, Mark
中科院分区：
文献类型：
--
作者：
Lackner, Jeffrey M.;Keefer, Laurie;Byroads, Mark
肠易激综合症是一种常见的、常常致残的胃肠道疾病，其各种症状尚无令人满意的药物或饮食治疗。少数经经验验证的治疗方法之一包括一种称为认知行为疗法的特定心理疗法，如果有这种疗法，通常由三级护理机构中经过培训的从业人员在几个月内进行治疗。迫切需要开发更有效的 CBT 版本，该版本需要最少的专业帮助，但保留基于临床的 CBT 的功效特征。肠易激综合症结果研究 (IBSOS) 是一项多中心、安慰剂对照随机试验，旨在评估自我管理的 CBT 是否至少与标准 CBT 一样有效，并且比注意力控制更有效地减轻中度至重度 IBS 患者的 IBS 核心胃肠道症状及其负担（例如痛苦、生活质量受损等）。其他目标是每季度评估 12 个月内治疗反应的持久性；确定与结果相关的临床上有用的患者特征，作为了解 CBT 最有益的参与者亚组的一种方式；确定基于理论的变革机制（活性成分），解释 CBT 如何以及为何发挥作用；并评估 CBT 的经济成本和收益。从 2010 年 8 月 IBSOS 开始招募受试者到 2012 年 2 月，IBSOS 对 480 名患者中的 171 名患者进行了随机分组。研究结果有可能改善 IBS 患者的健康，降低其社会和经济成本，节省稀缺的医疗保健资源，并为循证实践指南提供信息。 (C) 2012 Elsevier Inc. 保留所有权利。
Irritable bowel syndrome is a common, oftentimes disabling, gastrointestinal disorder whose full range of symptoms has no satisfactory medical or dietary treatment. One of the few empirically validated treatments includes a specific psychological therapy called cognitive behavior therapy which, if available, is typically administered over several months by trained practitioners in tertiary care settings. There is an urgent need to develop more efficient versions of CBT that require minimal professional assistance but retain the efficacy profile of clinic based CBT. The Irritable Bowel Syndrome Outcome Study (IBSOS) is a multicenter, placebo-controlled randomized trial to evaluate whether a self-administered version of CBT is, at least as efficacious as standard CBT and more efficacious than an attention control in reducing core GI symptoms of IBS and its burden (e.g. distress, quality of life impairment, etc.) in moderately to severely affected IBS patients. Additional goals are to assess, at quarterly intervals, the durability of treatment response over a 12 month period; to identify clinically useful patient characteristics associated with outcome as a way of gaining an understanding of subgroups of participants for whom CBT is most beneficial; to identify theory-based change mechanisms (active ingredients) that explain how and why CBT works; and evaluate the economic costs and benefits of CBT. Between August 2010 when IBSOS began recruiting subjects and February 2012, the IBSOS randomized 171 of 480 patients. Findings have the potential to improve the health of IBS patients, reduce its social and economic costs, conserve scarce health care resources, and inform evidence-based practice guidelines. (C) 2012 Elsevier Inc. All rights reserved.