Irritable Bowel SyndromeNCT00738920
Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome
A study testing Self Administered Cognitive Behavior Therapy, Therapist Administered Cognitive Behavior Therapy and Behavioral Education and Supportive Therapy in people with Irritable Bowel Syndrome, run by State University of New York at Buffalo at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Self Administered Cognitive Behavior Therapy, Therapist Administered Cognitive Behavior Therapy and Behavioral Education and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University at Buffalo School of Medicine
Buffalo, New York, 14215
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Self Administered CBT for IBS: A Multisite Trial
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
- Irritable Bowel Syndrome
- Being tested
- Self Administered Cognitive Behavior Therapy, Therapist Administered Cognitive Behavior Therapy, Behavioral Education and Supportive Therapy
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Administered Cognitive Behavior TherapyBehavioural
This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
Therapist Administered Cognitive Behavior TherapyBehavioural
This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
Behavioral Education and Supportive TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| MC-CBT | Active comparator | Self Administered Cognitive Behavior Therapy Receives: Behavioral: Self Administered Cognitive Behavior Therapy |
| Standard-CBT | Active comparator | Therapist Administered Cognitive Behavior Therapy Receives: Behavioral: Therapist Administered Cognitive Behavior Therapy |
| Education/Support | Active comparator | Behavioral Patient Education/Counseling Receives: Behavioral: Behavioral Education and Supportive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-Up
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2-Week Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startAug 2010
- Primary completionDec 2016
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University, Frontier Science & Technology Research Foundation, Inc., RTI International
- Responsible party
- Principal investigator, Jeffrey Lackner, State University of New York at Buffalo
- Investigators
- Jeffrey Lackner, PsyD, Principal investigator, State University of New York at BuffaloLaurie Keefer, Ph.D., Principal investigator, Ichan School of Medicine at Mount SinaiJeffrey Lackner, Psy.D., Study chair, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738920
- Sponsor's protocol ID
- DK77738
- Other IDs
- U01DK077738
- Status last verified
- Jul 2022
- First submitted
- 19 Aug 2008
- Last updated
- 5 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- 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.
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 34847963Lackner 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.
PubMed 29702118Lackner 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Administered CBT for IBS: A Multisite Trial
- ClinicalTrials.gov ID
- NCT00738920
- Acronym / sponsor ID
- DK77738
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University, Frontier Science & Technology Research Foundation, Inc., RTI International
- Study start
- Aug 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Posted 6 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MC-CBT | Active comparator | Behavioral: Self Administered Cognitive Behavior TherapySelf Administered Cognitive Behavior Therapy |
| Standard-CBT | Active comparator | Behavioral: Therapist Administered Cognitive Behavior TherapyTherapist Administered Cognitive Behavior Therapy |
| Education/Support | Active comparator | Behavioral: Behavioral Education and Supportive TherapyBehavioral Patient Education/Counseling |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self Administered Cognitive Behavior TherapyThis 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS | Behavioural | MC-CBT |
| Therapist Administered Cognitive Behavior TherapyThis 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS | Behavioural | Standard-CBT |
| Behavioral Education and Supportive TherapyThis 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 | Behavioural | Education/Support |
Primary outcome
Clinical Global Impressions - Improvement Scale (CGI-I; Patient Version)
Time frame: 2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-Up
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.
2 secondary outcomes
Change From Baseline on the IBS Symptom Severity Scale (IBS-SSS)
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)
Time frame: 2-Week Follow-Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34847963Jacobs 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.
- Derived from this study: PubMed 29702118Lackner 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.
- Derived from this study: PubMed 22846389Lackner 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Administered Cognitive Behavior Therapy, Therapist Administered Cognitive Behavior Therapy and Behavioral Education and Supportive Therapy in people with Irritable Bowel Syndrome, run by State University of New York at Buffalo at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impressions - Improvement Scale (CGI-I; Patient Version) (time frame: 2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00738920, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022; AzTrials last refreshed its copy on 1 Nov 2026.