• Global improvement of IBS symptoms (CGI) [ Time Frame: 2 weeks after treatment ends and at 3, 6, 9. and 12 months after treatment ends ] [ Designated as safety issue: No ]
  

• Quality of life (SF-36; IBS-QOL) Psychological distress (BSI) Coping (CSQ, Advere Events Cost Health Care utilization Patient Satisfaction (CSQ) Stool consistency (BSFS) Daily patient assessent of IBS symptoms [ Time Frame: 2 weeks after treatment ends and at 3, 6, 9. and 12 months after treatment ends ] [ Designated as safety issue: Yes ]
  

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 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.

Inclusion Criteria:

• Inclusion criteria are (a) males or female patients aged 18 to 70 years (inclusive); (b) an established Rome III diagnosisfor IBS with symptoms of at least moderate severity (at least 2 days weekly); (c) a minimum 6th grade reading level based on the Wide Range Achievement Test (WRAT 4208); (d) willingness and ability to give informed consent; (e) receiving no medications or, if taking medications, a willingness and ability to maintain a stable dose of medications through the four week baseline period prior to randomization.

Exclusion Criteria:

• (a) concurrent psychological therapy and unwillingness or inability to stop treatment for the duration of the study; (b) a history of having previously received actual CBT treatments being evaluated in the study, (c) the presence of a diagnosed organic GI disease (e. g. IBD, colorectal cancer, history of lactose intolerance or relief from symptoms on a lactose-free diet) that would provide a structural or biochemical explanation of patients' symptoms or an unstable extraintestinal medical condition whose immediate or foreseeable treatment needs (e.g., hospitalization) would interfere with study demands (e.g., attend treatment sessions and/or inability to participate in telephone interventions); (d) previous abdominal surgery (uncomplicated appendectomy, hysterectomy or cholecystectomy at least 6 months prior to entry acceptable); (e) positive for current DSM-IV diagnosis of major depression diagnosis with a high risk of suicidal behavior (i.e. intent or plan), alcohol or substance abuse/dependence within the past year, a lifetime history of schizophrenia or schizoaffective disorder (as determined by MINI Neuropsychiatric Interview - Plus; (e) gross cognitive impairment, as evidenced by clinical impression and poor performance (< 23) on the Mini Mental Status Exam 210; and (f) any evidence of malignancy within the previous 5 years (with the exception of localized carcinoma of the skin); (g) evidence of currenor recent (previous 2 weeks) infectious disease (e.g., flu) that would obscure presentation of IBS symptoms