Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome

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.

Conditions

• Irritable Bowel Syndrome

Interventions

BEHAVIORAL

Self Administered Cognitive Behavior Therapy

This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS

BEHAVIORAL

Therapist Administered Cognitive Behavior Therapy

This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS

BEHAVIORAL

Behavioral Education and Supportive Therapy

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Northwestern University Feinberg School of Medicine

  collaborator OTHER

• Frontier Science & Technology Research Foundation, Inc.

  collaborator INDUSTRY

• RTI International

  collaborator OTHER

• State University of New York at Buffalo

  lead OTHER

Principal Investigators

• Jeffrey Lackner, PsyD · State University of New York at Buffalo

• Laurie Keefer, Ph.D. · Ichan School of Medicine at Mount Sinai

• Jeffrey Lackner, Psy.D. · State University of New York at Buffalo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2016-12-31

Completion

2017-08-31

Countries

• United States

Study Locations