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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK077738-06
Application #
8546336
Study Section
Special Emphasis Panel (ZDK1-GRB-C (O1))
Program Officer
Hamilton, Frank A
Project Start
2008-05-15
Project End
2015-04-30
Budget Start
2013-05-01
Budget End
2014-04-30
Support Year
6
Fiscal Year
2013
Total Cost
$1,270,666
Indirect Cost
$320,773
Name
State University of New York at Buffalo
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
038633251
City
Buffalo
State
NY
Country
United States
Zip Code
14260
Lackner, J M; Jaccard, J; Keefer, L et al. (2014) The accuracy of patient-reported measures for GI symptoms: a comparison of real time and retrospective reports. Neurogastroenterol Motil 26:1802-11
Lackner, Jeffrey M; Gudleski, Gregory D; Dimuro, Jennifer et al. (2013) Psychosocial predictors of self-reported fatigue in patients with moderate to severe irritable bowel syndrome. Behav Res Ther 51:323-31
Lackner, Jeffrey M; Gudleski, Gregory D; Firth, Rebecca et al. (2013) Negative aspects of close relationships are more strongly associated than supportive personal relationships with illness burden of irritable bowel syndrome. J Psychosom Res 74:493-500
Lackner, Jeffrey M; Jaccard, James; Baum, Charles (2013) Multidomain patient-reported outcomes of irritable bowel syndrome: exploring person-centered perspectives to better understand symptom severity scores. Value Health 16:97-103
Lackner, Jeffrey M; Ma, Chang-Xing; Keefer, Laurie et al. (2013) Type, rather than number, of mental and physical comorbidities increases the severity of symptoms in patients with irritable bowel syndrome. Clin Gastroenterol Hepatol 11:1147-57
Kwiatek, M A; Kiebles, J L; Taft, T H et al. (2011) Esophageal symptoms questionnaire for the assessment of dysphagia, globus, and reflux symptoms: initial development and validation. Dis Esophagus 24:550-9
Lackner, Jeffrey; Jaccard, James; Baum, Charles et al. (2011) Patient-reported outcomes for irritable bowel syndrome are associated with patients' severity ratings of gastrointestinal symptoms and psychological factors. Clin Gastroenterol Hepatol 9:957-964.e1
Kiebles, Jennifer L; Doerfler, Bethany; Keefer, Laurie (2010) Preliminary evidence supporting a framework of psychological adjustment to inflammatory bowel disease. Inflamm Bowel Dis 16:1685-95
Lackner, Jeffrey M; Jaccard, James; Krasner, Susan S et al. (2008) Self-administered cognitive behavior therapy for moderate to severe irritable bowel syndrome: clinical efficacy, tolerability, feasibility. Clin Gastroenterol Hepatol 6:899-906