Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome

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.

Inclusion Criteria:

- Males or female patients aged 18 to 70 years (inclusive);

- All ethnic groups;

- Meet Rome III criteria for IBS with symptoms of at least moderate severity (at least 2
days per week);

- Ability to understand and provide informed consent;

- With the exception of antibiotics, participant is willing to remain on a stable dose
only through the 4-week pretreatment baseline period prior to randomization;

- Participant either not taking medications or if taking medications willing to suspend
starting any new medications only during the initial 4-week pretreatment baseline
period;

- Participant demonstrates an ability to speak understand and read, English a the sixth
grade level or higher;

- Willingness to be randomized to CBT or Support/Education to which s/he has been
assigned to to adhere to protocol requirements;

- Participant is willing to attend regularly scheduled therapy session during active
phase of the trial;

- Participant is willing to be contacted and scheduled for follow-up assessment at week
12 and 3, 6, 9, and 12 months after the conclusion of acute treatment phase;

- Participant is willing and able to enter symptom information into an assigned portable
computer and complete questionnaires through treatment and at regularly scheduled
follow ups

- Participant has access to a telephone; and

- Participant is willing and able to provide adequate information for locator purposes.

Exclusion Criteria:

- Evidence of current structural or biochemical abnormalities or medication use that
better explain the participant's IBS symptoms (e.g. IBD);

- Evidence of a current infection or infection of any type within the 2 weeks prior to
the study gastroenterologists' evaluation which would obscure the presentation of IBS
symptoms. In such cases the baseline can be delayed until 2 weeks after complete
recovery.

- Participant has received antibiotics (e.g. rifaximin and or neomycin) specifically
targeted to treat IBS symptoms within the past 3 months. In this instance eligibility
will be suspended for 12 weeks from the initial date the antibiotic was consumed.

- Participant has undergone previous abdominal surgery that would have caused
significant alternation of the anatomy/physiology of the digestive/GI tract, which
adequately explains GI symptoms;

- Participant has been diagnosed and/or treated for malignancy in the past 5 years with
the exception of localized basal or squamous cell carcinomas of the skin;

- Participant has an unstable extraintestinal medical condition whose immediate or
foreseeable treatment needs (e.g., hospitalization, conflicting physician visits)
would realistically interfere with study demands (e.g., consistent attendance at
treatment sessions and/or ability to participate in telephone interventions) or may
affect the interpretation of clinical efficacy data;

- Participant has a major psychiatric disorder, which in the opinion of the senior
clinical staff may impede conduct of the clinical trial. These disorders include but
are not limited to 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 or gross cognitive
impairments;

- Participant has other conditions which in the opinion of the senior clinical staff
would influence negatively the conduct of the clinical trial;

- Participant is currently receiving targeted psychotherapy for IBS and is unwilling or
unable to discontinue his/her treatment for the acute treatment phase of this study;

- Participant is unable to complete all scheduled screening visits; and participant is
inaccessible for interventions and/or follow-up evaluations.