Self-Administered CBT for IBS: A Multicenter Trial

描述(由申请人提供)： 肠易激综合征(IBS)是一种慢性、流行、经常致残的胃肠道疾病，其所有症状(腹痛、肠功能障碍)都没有可靠和令人满意的医疗选择。越来越多的证据表明，一种名为认知行为疗法(CBT)的特定心理社会治疗与IBS症状和相关困难的显著减少有关。尽管CBT有明显的疗效，但由于其持续时间、成本和可获得性有限，其临床有效性(即普适性、可行性、成本效益)尚未得到充分确立。随着“第二代”IBS治疗方法的开发和验证，越来越清楚的是，疗效证明是治疗可行性的必要条件，但不是充分条件。在由NIDDK的R03机制资助的一项试点研究中，我们通过开发一种更简短的、基本上是自我管理的CBT版本来解决这些问题，该版本只需要4次半的临床就诊。我们的随机对照试验数据显示，CBT的10疗程版本可以转换为4疗程版本，而不会影响患者的可接受性或短期疗效。目前尚不清楚的是，由于理论上的变化机制(与不同治疗形式中常见的非特定因素相比)，治疗效果是否能长期保持(长达12个月)，是在特定的患者亚组中更明显，还是推广到由不同研究地点治疗的罗马III确诊患者的大样本。为了解决这些问题，我们开展了一项规模更大、更明确、多点的随机对照试验，从3个治疗地点招募480名中重度IBS患者，评估他们对短期(4个疗程)CBT、延长(10个疗程)CBT或可信的注意安慰剂的急性和长期反应。我们将利用第一年开发临床基础设施[原文如此]，以确保拟议试验的成功和完整性。短期内，一项成功的试验将对自我给药版本的CBT进行经验验证，该版本保留了标准CBT的疗效，但更易于移植，研究方案之外的患者可以获得，而且交付成本更低。从长远来看，我们希望表明，自我指导的行为治疗计划是一种有效和高效的治疗提供系统，可以提高患者护理质量，改善临床结果，并降低最普遍和最难治的胃肠道疾病之一的经济和个人成本。这项拟议试验的主要目标是评估认知行为疗法(CBT)使用两种治疗系统(自身给药和治疗师给药)治疗肠易激综合征的短期和长期疗效。次级目标力求具体说明CBT可以(或不可以)实现其效果的条件(主持人问题)、为什么以及如何实现这些效果(调解人问题)以及经济成本。长期的项目目标是开发一种有效的自我管理的行为治疗计划，以提高患者护理的质量，改善临床结果，并降低最普遍和最难治的胃肠道疾病之一的经济和个人成本。

DESCRIPTION (provided by applicant): Irritable bowel syndrome (IBS) is a chronic, prevalent, often disabling, GI disorder for which there is no reliable and satisfactory medical option for its full range of symptoms (abdominal pain, bowel dysfunction). An accumulating body of evidence indicates that a specific psychosocial treatment called cognitive behavioral therapy (CBT) is associated with significant reductions in IBS symptoms and related difficulties. Despite its apparent efficacy, CBT's clinical effectiveness (i.e., its generalizability, feasibility, cost effectiveness) has not been adequately established due partly to its duration, cost, and limited accessibility. As the "second generation" of IBS treatments undergo development and validation, it has become increasingly clear that efficacy demonstration is a necessary but not sufficient condition of treatment viability. In a pilot study funded under NIDDK's R03 mechanism, we addressed these problems by developing a briefer, largely self administered version of CBT that requires only 4, I hr clinic visits. Our RCT data showed that a 10 session version of CBT can be translated into a 4 session version without compromising patient acceptability or short term efficacy. It is unclear whether treatment effects are maintained long term (out to 12 months), due to theoretical change mechanisms (vs. nonspecific factors common across different forms of therapy), are more pronounced among specific subgroups of patients, or, generalize to a large sample of Rome III diagnosed patients treated by different investigative sites. We seek to address these questions by conducting a larger, more definitive, multisite RCT that will recruit from 3 treatment sites 480 patients with moderate to severe IBS and assess their acute and long term response to brief (4 session) CBT, extended (10 session) CBT, or a credible attention placebo. We will use the first year to develop a clinical infrastructrue [sic] to ensure the success and integrity of the proposed trial. In the short term, a successful trial will lend empirical validation to a self administered version of CBT that retains the efficacy of standard CBT but is more transportable, accessible to patients outside of research protocols, and less costly to deliver. In the long term, we hope to show that a self guided behavioral treatment program is an effective and efficient treatment delivery system that can enhance the quality of patient care, improve clinical outcomes, and decrease the economic and personal costs of one of the most prevalent and intractable GI disorders. The primary goal of the proposed trial is to assess the short- and long-term efficacy of cognitive behavior therapy (CBT) for irritable bowel syndrome using two treatment delivery systems (self administered, therapist administered). Secondary aims seek to specify the conditions under which CBT may (or may not) achieve its effects (moderator questions), why and how these effects are achieved (mediator questions) and at what economic cost. Long term project goals are to develop an effective self-administered behavioral treatment program that can enhance the quality of patient care, improve clinical outcomes, and decrease the economic and personal costs of one of the most prevalent and intractable GI disorders.