Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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, 1 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 2 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 education/support condition.
      We will use the first year to develop a clinical infrastructure 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.
    

Intervention name(s): Self Administered Cognitive Behavior Therapy; Therapist Administered Cognitive Behavior Therapy; Behavioral Education and Supportive Therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS; This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS; This 4 session treatment aims at controlling symptoms through support and the provision of information about IBS symptoms, how it is diagnosed, its causes, and treatment options and a collaborative, relationship between the patient and doctor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment