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Development of Limited Contact CBT Treatment for IBS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248586
First Posted: November 4, 2005
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
An accumulating body of evidence indicates that a specific psychological treatment called cognitive behavioral therapy (CBT) is associated with significant reductions in pain and bowel dysfunction of irritable bowel syndrome (IBS). Despite its apparent efficacy, the clinical effectiveness of CBT (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. One potential solution to the problem of clinical effectiveness is to develop a briefer, largely self administered version of CBT that retains the efficacy of standard CBT but is more transportable, accessible, and less costly to deliver. To this end, a two-stage project is proposed. The goals of the first stage will be to develop, refine, and pilot test an innovative limited therapist contact-CBT protocol patterned after treatments proven effective for painful medical disorders with similar pathophysiology as IBS. The primary aim of the second stage is to conduct a small randomized clinical trial (N = 75 patients meeting Rome II diagnostic criteria) of standard (10 session) version of CBT (S-CBT) and limited contact (4 session) version of CBT (LC-CBT) with reference to a wait list control to examine their comparative efficacy on multiple indices, including IBS symptoms (primary outcome variable), psychological distress, and quality of life. Secondary aims are (1) to identify patient characteristics that predict outcome; (2) obtain information regarding active change-inducing mechanisms that may underlie treatment outcome; and (3) obtain information regarding possible monetary benefits, cost-effectiveness, and cost-benefit of S-CBT versus LC-CBT protocols. Data from this trial would set the stage for an R01 funded multicenter study with a large, random, and representative sample that could establish the clinical effectiveness of LC-CBT and in so doing make a significant contribution toward more efficient and effective care of IBS.

Condition Intervention
IBS Behavioral: Standard CBT (S-CBT) Behavioral: Minimal contact CBT (MC-CBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Limited Contact CBT Treatment for IBS

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Adequate relief - abdominal pain [ Time Frame: 12 weeks ]
    In the past 7 days, have you had adequate relief from irritable bowel syndrome pain or discomfort?" (Yes/No).

  • Global symptom improvement [ Time Frame: 12 weeks ]
    Compared to how you felt prior to entering the study, how would you rate the IBS symptoms for which you sought treatment during the past week?" (1, substantially improved; 4, no change; 7, substantially worse). Consistent with past research, we defined treatment responders a priori by a score of 1 (substantially) or 2 (moderately improved)


Secondary Outcome Measures:
  • IBS Quality of life [ Time Frame: 12 weeks ]
  • Psychological distress [ Time Frame: 12 weeks ]
    Global Severity Index of the Brief Symptom Inventory

  • IBS Symptom severity [ Time Frame: 12 weeks ]
    IBS Symptom Severity Scale


Enrollment: 75
Actual Study Start Date: February 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard CBT (S-CBT) Behavioral: Standard CBT (S-CBT)
Standard CBT (S-CBT) is a skills-based training program delivered to patients in 10 weekly, 1-hour sessions.
Experimental: Minimal contact CBT (MC-CBT) Behavioral: Minimal contact CBT (MC-CBT)
Minimal contact CBT (MC-CBT) covers the same range of procedures featured in S-CBT but relies extensively on self study materials.
No Intervention: Control

Detailed Description:
An accumulating body of evidence indicates that a specific psychological treatment called cognitive behavioral therapy (CBT) is associated with significant reductions in pain and bowel dysfunction of irritable bowel syndrome (IBS). Despite its apparent efficacy, the clinical effectiveness of CBT (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. One potential solution to the problem of clinical effectiveness is to develop a briefer, largely self administered version of CBT that retains the efficacy of standard CBT but is more transportable, accessible, and less costly to deliver. To this end, a two-stage project is proposed. The goals of the first stage will be to develop, refine, and pilot test an innovative limited therapist contact-CBT protocol patterned after treatments proven effective for painful medical disorders with similar pathophysiology as IBS. The primary aim of the second stage is to conduct a small randomized clinical trial (N = 75 patients meeting Rome II diagnostic criteria) of standard (10 session) version of CBT (S-CBT) and limited contact (4 session) version of CBT (LC-CBT) with reference to a wait list control to examine their comparative efficacy on multiple indices, including IBS symptoms (primary outcome variable), psychological distress, and quality of life. Secondary aims are (1) to identify patient characteristics that predict outcome; (2) obtain information regarding active change-inducing mechanisms that may underlie treatment outcome; and (3) obtain information regarding possible monetary benefits, cost-effectiveness, and cost-benefit of S-CBT versus LC-CBT protocols. Data from this trial would set the stage for an R01 funded multicenter study with a large, random, and representative sample that could establish the clinical effectiveness of LC-CBT and in so doing make a significant contribution toward more efficient and effective care of IBS.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria. To be included in the investigation, patients will have to: (a) be between the ages of 18 and 70 years of age; (b) meet Rome II criteria (66) for irritable bowel syndrome whose symptoms occur at least 2 days per week for 6 months or greater; (c) have a minimum 6th grade reading level based on the Wide Range Achievement Test (WRAT); (d) be willing to sign a consent form stating their willingness to participate in and participate in all phases of the investigation; (e) take either no IBS medications, or if taking medications, be on a stable dose for at least three months prior to trial entry with an understanding that dosage be maintained at pretreatment level(s) unless change is medically necessary.

Exclusion Criteria:

  • Exclusion criteria. Patients will be excluded from the study if they (a) are undergoing concurrent psychological therapy and are unwilling or unable to stop treatment for the duration of the study; (b) have a history of having previously received actual CBT treatments being evaluated in the study, (c) have a diagnosed organic GI disorder or show current suicidality, substance abuse, psychosis in which case they will be referred for appropriate treatment; (e) are intellectually unable or unwilling to complete daily GI ratings
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248586


Locations
United States, New York
UB, SUNY School of Medicine
Buffalo, New York, United States, 14215
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Jeffrey Lackner, PsyD UB, SUNY
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00248586     History of Changes
Other Study ID Numbers: R03 DK67878 (completed 2007)
R03DK067878 ( U.S. NIH Grant/Contract )
First Submitted: November 1, 2005
First Posted: November 4, 2005
Last Update Posted: October 13, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No