Development of Limited Contact CBT Treatment for IBS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Adequate relief - abdominal pain
研究概览
简要总结
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 wait list 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.
详细描述
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 wait list 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria. To be included in the investigation, patients will have to: (a) be between the ages of 18 and 70 years of age; (b) meet Rome II criteria (66) for irritable bowel syndrome whose symptoms occur at least 2 days per week for 6 months or greater; (c) have a minimum 6th grade reading level based on the Wide Range Achievement Test (WRAT); (d) be willing to sign a consent form stating their willingness to participate in and participate in all phases of the investigation; (e) take either no IBS medications, or if taking medications, be on a stable dose for at least three months prior to trial entry with an understanding that dosage be maintained at pretreatment level(s) unless change is medically necessary.
排除标准
- •Exclusion criteria. Patients will be excluded from the study if they (a) are undergoing concurrent psychological therapy and are unwilling or unable to stop treatment for the duration of the study; (b) have a history of having previously received actual CBT treatments being evaluated in the study, (c) have a diagnosed organic GI disorder or show current suicidality, substance abuse, psychosis in which case they will be referred for appropriate treatment; (e) are intellectually unable or unwilling to complete daily GI ratings
研究组 & 干预措施
Standard CBT (S-CBT)
干预措施: Standard CBT (S-CBT) (Behavioral)
Minimal contact CBT (MC-CBT)
干预措施: Minimal contact CBT (MC-CBT) (Behavioral)
Control
结局指标
主要结局
Adequate relief - abdominal pain
时间窗: 12 weeks
In the past 7 days, have you had adequate relief from irritable bowel syndrome pain or discomfort?" (Yes/No).
Global symptom improvement
时间窗: 12 weeks
Compared to how you felt prior to entering the study, how would you rate the IBS symptoms for which you sought treatment during the past week?" (1, substantially improved; 4, no change; 7, substantially worse). Consistent with past research, we defined treatment responders a priori by a score of 1 (substantially) or 2 (moderately improved)
次要结局
- IBS Symptom severity(12 weeks)
- IBS Quality of life(12 weeks)
- Psychological distress(12 weeks)