CompletedNCT00738920Updated Aug 5, 2022Results posted

Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome

An interventional study of Self Administered Cognitive Behavior Therapy and Therapist Administered Cognitive Behavior Therapy in Irritable Bowel Syndrome, sponsored by State University of New York at Buffalo. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-05.

Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 436
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Irritable Bowel Syndrome

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In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 436 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 436 participants (actual)

Study arms

Active comparator
MC-CBT
Self Administered Cognitive Behavior Therapy
Behavioral: Self Administered Cognitive Behavior Therapy
Active comparator
Standard-CBT
Therapist Administered Cognitive Behavior Therapy
Behavioral: Therapist Administered Cognitive Behavior Therapy
Active comparator
Education/Support
Behavioral Patient Education/Counseling
Behavioral: Behavioral Education and Supportive Therapy

Interventions

BehavioralSelf Administered Cognitive Behavior Therapy
This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
BehavioralTherapist Administered Cognitive Behavior Therapy
This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
BehavioralBehavioral 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

What researchers measure

Primary outcomes

Clinical Global Impressions - Improvement Scale (CGI-I; Patient Version)
The CGI-I is a single-item, 7-point centered scale that integrates symptom severity and improvement since the start of treatment. Specific IBS-based anchor points were used, as is the convention for multi-symptom disease states. Response range from 1 (very much worse) to 7 (very much improved), with higher scores indicating greater symptom improvement. Participants who respond 6 (much improved) or 7 (very much improved) are classified as treatment responders.
Time frame: 2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-Up

Secondary outcomes

Change From Baseline on the IBS Symptom Severity Scale (IBS-SSS)
The IBS-SSS is a 5-item instrument used to measure severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with QOL. For four of the items, respondents mark a point on a 101 mm visual analogue scale to indicate their response to that item. The proportional distance from zero is the score (ranging from 0 to 100) assigned for that scale. The other item asks the number of days out of 10 the patient experiences abdominal pain and the answer is multiplied by 10 to create a 0 to 100 metric. The five items are summed and the total scores range from 0-500, with higher scores signifying more severe symptoms \[mild (\<175), moderate (175-300), severe (\>300)\]. A decrease of 50 points on the IBS-SSS is considered clinically significant.
Time frame: Baseline, 2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-Up
Client Satisfaction Questionnaire (CSQ)
The CSQ is an 8-item questionnaire that measures patient satisfaction with treatment. Scores range from 8 to 32 with higher scores indicating greater satisfaction with treatment.
Time frame: 2-Week Follow-Up

Results

Posted Jul 6, 2022

Participant flow

Baseline to 2-Week Follow-Up

Participant flow — Baseline to 2-Week Follow-Up
Milestone	MC-CBT	Standard-CBT	Education/Support
Started	145	146	145
Completed	129	123	130
Not completed	16	23	15
Withdrew: Lost to follow-up	8	9	8
Withdrew: Withdrawal by subject	8	14	7

2-Week Follow-Up to 3-Month Follow-Up

Participant flow — 2-Week Follow-Up to 3-Month Follow-Up
Milestone	MC-CBT	Standard-CBT	Education/Support
Started	129	123	130
Completed	121	111	118
Not completed	8	12	12
Withdrew: Withdrawal by subject	3	5	6
Withdrew: Lost to follow-up	5	7	6

3-Month Follow-Up to 6-Month Follow-Up

Participant flow — 3-Month Follow-Up to 6-Month Follow-Up
Milestone	MC-CBT	Standard-CBT	Education/Support
Started	121	111	118
Completed	117	111	115
Not completed	4	0	3
Withdrew: Lost to follow-up	3	0	2
Withdrew: Withdrawal by subject	1	0	1

6-Month Follow-Up to 9-Month Follow-Up

Participant flow — 6-Month Follow-Up to 9-Month Follow-Up
Milestone	MC-CBT	Standard-CBT	Education/Support
Started	117	111	115
Completed	113	104	103
Not completed	4	7	12
Withdrew: Lost to follow-up	2	4	7
Withdrew: Withdrawal by subject	2	3	5

9-Month Follow-Up to 12-Month Follow-Up

Participant flow — 9-Month Follow-Up to 12-Month Follow-Up
Milestone	MC-CBT	Standard-CBT	Education/Support
Started	113	104	103
Completed	112	103	102
Not completed	1	1	1
Withdrew: Lost to follow-up	1	0	1
Withdrew: Withdrawal by subject	0	1	0

Outcome measures

PrimaryClinical Global Impressions - Improvement Scale (CGI-I; Patient Version)

The CGI-I is a single-item, 7-point centered scale that integrates symptom severity and improvement since the start of treatment. Specific IBS-based anchor points were used, as is the convention for multi-symptom disease states. Response range from 1 (very much worse) to 7 (very much improved), with higher scores indicating greater symptom improvement. Participants who respond 6 (much improved) or 7 (very much improved) are classified as treatment responders.

Time frame:: 2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-Up
Reported as:: Number · percentage of treatment responders

Clinical Global Impressions - Improvement Scale (CGI-I; Patient Version)
percentage of treatment responders	MC-CBT	Standard-CBT	Education/Support
2-Week Follow-Up	68.1	64.6	46.7
3-Month Follow-Up	64.0	64.6	49.5
6-Month Follow-Up	63.9	58.1	51.0
9-Month Follow-Up	64.9	62.2	48.9
12-Month Follow-Up	70.0	68.4	51.7

SecondaryChange From Baseline on the IBS Symptom Severity Scale (IBS-SSS)

The IBS-SSS is a 5-item instrument used to measure severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with QOL. For four of the items, respondents mark a point on a 101 mm visual analogue scale to indicate their response to that item. The proportional distance from zero is the score (ranging from 0 to 100) assigned for that scale. The other item asks the number of days out of 10 the patient experiences abdominal pain and the answer is multiplied by 10 to create a 0 to 100 metric. The five items are summed and the total scores range from 0-500, with higher scores signifying more severe symptoms \[mild (\<175), moderate (175-300), severe (\>300)\]. A decrease of 50 points on the IBS-SSS is considered clinically significant.

Time frame:: Baseline, 2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-Up
Reported as:: Mean · units on a scale

Change From Baseline on the IBS Symptom Severity Scale (IBS-SSS)
units on a scale	MC-CBT	Standard-CBT	Education/Support
Change from Baseline to 2-Week Follow-Up	-89.4 ± 17.0	81.0 ± 17.0	84.4 ± 14.6
Change from Baseline to 3-Month Follow-Up	-105.9 ± 17.7	-103.2 ± 16.4	-88.5 ± 14.6
Change from Baseline to 6-Month Follow-Up	-111.3 ± 17.9	-103.5 ± 17.7	-97.93 ± 15.4
Change from Baseline to 9-Month Follow-Up	-111.2 ± 17.7	-104.6 ± 17.0	-94.9 ± 17.1
Change from Baseline to 12-Month Follow-Up	-120.1 ± 17.9	-112.9 ± 18.4	-103.4 ± 18.6

SecondaryClient Satisfaction Questionnaire (CSQ)

The CSQ is an 8-item questionnaire that measures patient satisfaction with treatment. Scores range from 8 to 32 with higher scores indicating greater satisfaction with treatment.

Time frame:: 2-Week Follow-Up
Reported as:: Mean · units on a scale

Client Satisfaction Questionnaire (CSQ)
units on a scale	MC-CBT	Standard-CBT	Education/Support
Client Satisfaction Questionnaire (CSQ)	28.9 (28.3 to 29.5)	28.4 (27.7 to 29.1)	26.6 (25.7 to 27.5)

Adverse events

Collected over 1 year. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MC-CBT	0/145 (0%)	0/145 (0%)	0/145 (0%)
Standard-CBT	0/146 (0%)	0/146 (0%)	0/146 (0%)
Education/Support	0/145 (0%)	1/145 (0.7%)	0/145 (0%)

Most frequent serious events

Most frequent serious events
Event	MC-CBT	Standard-CBT	Education/Support
Attempted suicideSocial circumstances	0/145	0/146	1/145

Baseline characteristics

Age, Continuous
Age, Continuous(years)	MC-CBT	Standard-CBT	Education/Support	Total
Mean	40.9 ± 14.6	41.1 ± 14.4	42.2 ± 15.4	41.4 ± 14.8

Sex: Female, Male
Sex: Female, Male(Participants)	MC-CBT	Standard-CBT	Education/Support	Total
Female	124	112	114	350
Male	21	34	31	86

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	MC-CBT	Standard-CBT	Education/Support	Total
American Indian or Alaska Native	0	0	0	0
Asian	2	3	2	7
Native Hawaiian or Other Pacific Islander	0	1	0	1
Black or African American	7	7	9	23
White	131	127	125	383
More than one race	4	4	6	14
Unknown or Not Reported	1	4	3	8

Predominant IBS Bowel Type
Predominant IBS Bowel Type(Participants)	MC-CBT	Standard-CBT	Education/Support	Total
Constipation	43	40	47	130
Diarrhea	59	67	62	188
Mixed	33	35	30	98
Undifferentiated	10	4	6	20

Duration of IBS symptoms
Duration of IBS symptoms(years)	MC-CBT	Standard-CBT	Education/Support	Total
Mean	15.7 ± 13.3	17.7 ± 13.3	17.7 ± 16.4	17.1 ± 14.4

Medication Use for IBS Symptoms
Medication Use for IBS Symptoms(Participants)	MC-CBT	Standard-CBT	Education/Support	Total
Pain medication	9	13	13	35
Bowel medication	86	87	98	271
Multisymptom medication	6	7	7	20
Psychiatric medication	8	12	6	26
None	36	27	21	84

Study locations

2 sites

Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611, United States
University at Buffalo School of Medicine
Buffalo, New York 14215, United States

References and documents

Publications

Jacobs JP, Gupta A, Bhatt RR, Brawer J, Gao K, Tillisch K, Lagishetty V, Firth R, Gudleski GD, Ellingson BM, Labus JS, Naliboff BD, Lackner JM, Mayer EA. Cognitive behavioral therapy for irritable bowel syndrome induces bidirectional alterations in the brain-gut-microbiome axis associated with gastrointestinal symptom improvement. Microbiome. 2021 Nov 30;9(1):236. doi: 10.1186/s40168-021-01188-6. PubMed 34847963 ↗
Lackner JM, Jaccard J, Keefer L, Brenner DM, Firth RS, Gudleski GD, Hamilton FA, Katz LA, Krasner SS, Ma CX, Radziwon CD, Sitrin MD. Improvement in Gastrointestinal Symptoms After Cognitive Behavior Therapy for Refractory Irritable Bowel Syndrome. Gastroenterology. 2018 Jul;155(1):47-57. doi: 10.1053/j.gastro.2018.03.063. Epub 2018 Apr 25. Erratum In: Gastroenterology. 2018 Oct;155(4):1281. doi: 10.1053/j.gastro.2018.09.049. PubMed 29702118 ↗
Lackner JM, Keefer L, Jaccard J, Firth R, Brenner D, Bratten J, Dunlap LJ, Ma C, Byroads M; IBSOS Research Group. The Irritable Bowel Syndrome Outcome Study (IBSOS): rationale and design of a randomized, placebo-controlled trial with 12 month follow up of self- versus clinician-administered CBT for moderate to severe irritable bowel syndrome. Contemp Clin Trials. 2012 Nov;33(6):1293-310. doi: 10.1016/j.cct.2012.07.013. Epub 2012 Jul 28. PubMed 22846389 ↗

Individual participant data

Plan to share: Yes — One of the main goals of the IBSOS is to establish a central repository of data for subsequent hypothesis-based research designed to enable the widest dissemination of data, while also protecting the privacy of the participants and the utility of the data by de-identification and masking of potentially sensitive data elements. To support these objectives we will catalog and provide basic results sets through the NIDDK repository www.niddkrepository.org, as well as create and deliver more comprehensive de-identified data sets, for each completed aim of the IBSOS study. Study data will be provided in SAS/SPSS format and will be named to match corresponding codebooks or dictionary and study forms, which will also be located within the Repository. Codebooks will include variable names and labels, where applicable. For analysis data sets, we will provide documentation for analyses conducted for manuscript publication as well as descriptive summaries for main variables.

Supporting information: Study protocol, Sap, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00738920
Lead sponsor: State University of New York at Buffalo
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University Feinberg School of Medicine, Frontier Science & Technology Research Foundation, Inc., RTI International
Responsible party: Jeffrey Lackner (Principal investigator, State University of New York at Buffalo) — Principal investigator
First posted: Aug 21, 2008
Start date: Aug 2010
Primary completion: Dec 2016
Completion: Aug 31, 2017
Results posted: Jul 6, 2022
Last update: Aug 5, 2022

Study contacts

Jeffrey Lackner, PsyD

principal investigator · State University of New York at Buffalo

Laurie Keefer, Ph.D.

principal investigator · Ichan School of Medicine at Mount Sinai

Jeffrey Lackner, Psy.D.

study chair · State University of New York at Buffalo

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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