Development of Limited Contact CBT Treatment for IBS

NCT00248586 | Completed

• 2 other identifiers: R03 DK67878 (completed 2007)R03DK067878
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IBS

Outcome Measures

Primary Outcomes (2)

• Adequate relief - abdominal pain

  In the past 7 days, have you had adequate relief from irritable bowel syndrome pain or discomfort?" (Yes/No).

  12 weeks

• Global symptom improvement

  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)

  12 weeks

Secondary Outcomes (3)

• IBS Quality of life

  12 weeks

• Psychological distress

  12 weeks

• IBS Symptom severity

  12 weeks

Study Arms (3)

Standard CBT (S-CBT)

EXPERIMENTAL

Behavioral: Standard CBT (S-CBT)

Minimal contact CBT (MC-CBT)

EXPERIMENTAL

Behavioral: Minimal contact CBT (MC-CBT)

Control

NO INTERVENTION

Interventions

Standard CBT (S-CBT) BEHAVIORAL

Standard CBT (S-CBT) is a skills-based training program delivered to patients in 10 weekly, 1-hour sessions.

Standard CBT (S-CBT)

Minimal contact CBT (MC-CBT) BEHAVIORAL

Minimal contact CBT (MC-CBT) covers the same range of procedures featured in S-CBT but relies extensively on self study materials.

Minimal contact CBT (MC-CBT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

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

Study Sites (1)

UB, SUNY School of Medicine

Buffalo, New York, 14215, United States

Location

Related Publications (2)

• Lackner JM, Jaccard J, Krasner SS, Katz LA, Gudleski GD, Holroyd K. Self-administered cognitive behavior therapy for moderate to severe irritable bowel syndrome: clinical efficacy, tolerability, feasibility. Clin Gastroenterol Hepatol. 2008 Aug;6(8):899-906. doi: 10.1016/j.cgh.2008.03.004. Epub 2008 Jun 4.

  PMID: 18524691 RESULT

• Lackner JM, Gudleski GD, Keefer L, Krasner SS, Powell C, Katz LA. Rapid response to cognitive behavior therapy predicts treatment outcome in patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2010 May;8(5):426-32. doi: 10.1016/j.cgh.2010.02.007. Epub 2010 Feb 17.

  PMID: 20170751 DERIVED

Study Officials

• Jeffrey Lackner, PsyD

  UB, SUNY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2005
• First Posted: November 4, 2005
• Study Start: February 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

US (1)