Development of limited contact CBT treatment for IBS

描述（由申请人提供）： 越来越多的证据表明，一种称为认知行为疗法（CBT）的特定心理治疗与肠易激综合征（IBS）疼痛和肠功能障碍的显着减少有关。尽管CBT具有明显的疗效，但其临床有效性（即，其普遍性、可行性、成本效益）尚未充分确定，部分原因是其期限、费用和有限的可及性。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。临床有效性问题的一个潜在解决方案是开发一种更简短，主要是自我管理的CBT版本，保留标准CBT的功效，但更易于运输，更容易获得，成本更低。为此，提出了一个分两个阶段的项目。第一阶段的目标将是开发，完善和试点测试一种创新的有限治疗师接触CBT协议，该协议是在治疗被证明对具有与IBS相似病理生理学的疼痛性医学疾病有效后形成的。第二阶段的主要目的是进行小型随机临床试验（N = 75例符合罗马II诊断标准的患者）（10节）CBT（S-CBT）和有限接触版本CBT（LC-CBT）（4个疗程）版本，参考等待列表对照，以检查其对多个指标（包括IBS症状）的比较疗效（主要结果变量），心理困扰和生活质量。次要目的是（1）确定预测结果的患者特征;（2）获得有关可能构成治疗结果的主动变化诱导机制的信息;（3）获得有关S-CBT与LC-CBT方案可能的货币收益、成本效益和成本效益的信息。这项试验的数据将为R 01资助的多中心研究奠定基础，该研究具有大型，随机和代表性样本，可以确定LC-CBT的临床有效性，并为IBS的更有效和更有效的护理做出重大贡献。

DESCRIPTION (provided by applicant): An accumulating body of evidence indicates that a specific psychological treatment called cognitive behavioral therapy (CBT) is associated with significant reductions in pain and bowel dysfunction of irritable bowel syndrome (IBS). Despite its apparent efficacy, the clinical effectiveness of CBT (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. One potential solution to the problem of clinical effectiveness is to develop a briefer, largely self administered version of CBT that retains the efficacy of standard CBT but is more transportable, accessible, and less costly to deliver. To this end, a two-stage project is proposed. The goals of the first stage will be to develop, refine, and pilot test an innovative limited therapist contact-CBT protocol patterned after treatments proven effective for painful medical disorders with similar pathophysiology as IBS. The primary aim of the second stage is to conduct a small randomized clinical trial (N = 75 patients meeting Rome II diagnostic criteria) of standard (10 session) version of CBT (S-CBT) and limited contact (4 session) version of CBT (LC-CBT) with reference to a waitlist control to examine their comparative efficacy on multiple indices, including IBS symptoms (primary outcome variable), psychological distress, and quality of life. Secondary aims are (1) to identify patient characteristics that predict outcome; (2) obtain information regarding active change-inducing mechanisms that may underlie treatment outcome; and (3) obtain information regarding possible monetary benefits, cost-effectiveness, and cost-benefit of S-CBT versus LC-CBT protocols. Data from this trial would set the stage for an R01 funded multicenter study with a large, random, and representative sample that could establish the clinical effectiveness of LC-CBT and in so doing make a significant contribution toward more efficient and effective care of IBS.