Irritable Bowel SyndromeIBSNCT02313246
A Pilot Study of Cognitive-Behaviour Therapy for Irritable Bowel Syndrome and the Gut Microbiome
A study testing Group Cognitive Behaviour Therapy in people with Irritable Bowel Syndrome, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
This study evaluates the effectiveness of a group cognitive behaviour therapy for Irritable Bowel Syndrome (IBS) in decreasing symptoms of IBS, improving quality of life, and normalizing the gut microbiome. 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?
- Group Cognitive Behaviour Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosed with irritable bowel syndrome
- Able to commit to attending weekly 2-hour group sessions for 12 weeks
Who cannot join
- Use of antibiotics, or probiotics during the 4-week period prior to enrolling in the study
- Changes in medications during the 4-week period prior to enrolling in the study
- Presence of a major medical illness that may change the gut microbiome (e.g., any comorbid gastroenterological, rheumatological, or immunological disorder)
- Diagnosis of a major psychiatric disorder that is likely to impede participation in group therapy (e.g., depression with active suicidality, psychosis, or gross cognitive impairment)
- Received psychotherapy for IBS within the past 5 years
- Inability to read or complete symptom diaries or questionnaires
- Inability or unwillingness to provide or sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effectiveness of a group cognitive behaviour therapy for Irritable Bowel Syndrome (IBS) in decreasing symptoms of IBS, improving quality of life, and normalizing the gut microbiome. Patients will complete an 11-week group cognitive behaviour therapy for IBS within 1 month of being deemed eligible for the study.
Read the detailed description
Irritable bowel syndrome (IBS) is a chronic, disabling functional gastrointestinal disorder that is characterized by abdominal pain or discomfort and a disturbance in bowel habit. Approximately five million Canadians currently suffer with this chronic illness, which can have a significant impact on work and school absenteeism, productivity, social functioning and quality of life (Fedorak et al., 2012). Although the etiology of IBS is still unclear, there is increased interest in the role of the gut-brain axis in the development and maintenance of IBS. A growing body of evidence has identified changes in the composition, temporal stability and metabolic activity of the gut microbiome in IBS (Bolino \& Bercik, 2010). Moreover, there is evidence for bidirectional communication between the gut and the brain, such that the gut microbiota appear to influence as well as be modulated by brain activity through neurohumoral mechanisms (Collins, Surette, \& Bercik, 2012).
Currently, medications are the most widely used treatment for IBS (Ford et al., 2009; Ford et al., 2014). Although there is good evidence for the effectiveness of medications in reducing IBS symptomatology and improving quality of life, these medications are also often associated with unpleasant side effects. As a result, there is a growing interest in the utilization of psychological treatments, including cognitive behaviour therapy, for IBS. Cognitive behaviour therapy is a psychotherapeutic approach that addresses maladaptive cognitive processes and behaviours in a systematic, explicit fashion. Although there is good evidence for the effectiveness of cognitive behaviour therapy for the treatment of IBS (Ford et al., 2009; Ford et al., 2014), there is a lack of research examining the mechanisms through which cognitive behaviour therapy influences symptoms of IBS.
Accordingly, the current study has three aims: 1) to evaluate the effectiveness of group cognitive behaviour therapy for IBS on IBS symptomatology and quality of life; 2) to examine whether there are any changes in the gut microbiome from pre to posttreatment; and 3) to examine whether changes in the gut microbiome following cognitive behaviour therapy mediate changes in IBS symptomatology and quality of life. The current study has the potential of increasing knowledge about the role of the gut microbiome in IBS as well as the mechanisms of cognitive behaviour therapy for IBS.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Group Cognitive Behaviour 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.
Group Cognitive Behaviour TherapyBehavioural
This 11-week group treatment will cover the following topics: psychoeducation about IBS and the role of stress in exacerbating IBS symptoms, progressive muscle relaxation, stress management, problem solving, identifying and modifying maladaptive thinking patterns, decreasing behavioural avoidance, and exposure to feared physical sensations.
| Study group | Role | What they receive |
|---|---|---|
| Group Cognitive Behaviour Therapy | Experimental | Patients will complete an 11-session group cognitive behaviour therapy for IBS that will be led by two clinicians, one of whom will be a registered clinical psychologist, at the Digestive Diseases Clinic at McMaster University Medical Centre. The group cognitive behaviour therapy will include weekly 2-hour sessions for 11 weeks. Sessions will cover the following topics: psychoeducation about IBS and the role of stress in exacerbating IBS symptoms, progressive muscle relaxation, stress management, problem solving, identifying and modifying maladaptive thinking patterns, decreasing behavioural avoidance, and exposure to feared physical sensations. Receives: Behavioral: Group Cognitive Behaviour Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birmingham IBS Symptom Scale
Measured: baseline to 11 weeks
IBS Quality of Life
Measured: Baseline to 11 weeks
Changes in gut microbiome as assessed through analyzing fecal samples
Measured: Baseline to 6 weeks
Changes in gut microbiome as assessed through analyzing fecal samples
Measured: Baseline to 11 weeks
Secondary outcomes (16)
GI-Cognitions Questionnaire
Measured: Baseline to 6 weeks
GI-Cognitions Questionnaire
Measured: Baseline to 11 weeks
Visceral Sensitivity Index
Measured: Baseline to 6 weeks
Visceral Sensitivity Index
Measured: Baseline to 11 weeks
Visceral Sensitivity Index
Measured: 11 weeks to 15 weeks
Hospital Anxiety and Depression Scale
Measured: Baseline to 6 weeks
Hospital Anxiety and Depression Scale
Measured: Baseline to 11 weeks
Penn State Worry Questionnaire
Measured: Baseline to 6 weeks
Penn State Worry Questionnaire
Measured: Baseline to 11 weeks
UCLA Symptom Severity Scale
Measured: Weekly for 11 weeks
UCLA Symptom Severity Scale
Measured: 11 weeks to 15 weeks
Irritable Bowel Syndrome Symptom Severity Scale
Measured: Weekly for 11 weeks
Anxiety Sensitivity Index
Measured: Baseline to 6 weeks
Anxiety Sensitivity Index
Measured: Baseline to 11 weeks
IBS Quality of Life
Measured: 11 weeks to 15 weeks
Birmingham IBS Severity Scale
Measured: 11 weeks to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionDec 2015
Why it stopped: Principal investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Matilda E. Nowakowski, PhD, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313246
- Sponsor's protocol ID
- CBT-IBS-2015
- Acronym
- IBS
- Status last verified
- Mar 2016
- First submitted
- 5 Dec 2014
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fedorak RN, Vanner SJ, Paterson WG, Bridges RJ. Canadian Digestive Health Foundation Public Impact Series 3: irritable bowel syndrome in Canada. Incidence, prevalence, and direct and indirect economic impact. Can J Gastroenterol. 2012 May;26(5):252-6. doi: 10.1155/2012/861478.
PubMed 22590697Ford AC, Talley NJ, Schoenfeld PS, Quigley EM, Moayyedi P. Efficacy of antidepressants and psychological therapies in irritable bowel syndrome: systematic review and meta-analysis. Gut. 2009 Mar;58(3):367-78. doi: 10.1136/gut.2008.163162. Epub 2008 Nov 10.
PubMed 19001059Ford AC, Quigley EM, Lacy BE, Lembo AJ, Saito YA, Schiller LR, Soffer EE, Spiegel BM, Moayyedi P. Effect of antidepressants and psychological therapies, including hypnotherapy, in irritable bowel syndrome: systematic review and meta-analysis. Am J Gastroenterol. 2014 Sep;109(9):1350-65; quiz 1366. doi: 10.1038/ajg.2014.148. Epub 2014 Jun 17.
PubMed 24935275Collins SM, Surette M, Bercik P. The interplay between the intestinal microbiota and the brain. Nat Rev Microbiol. 2012 Nov;10(11):735-42. doi: 10.1038/nrmicro2876. Epub 2012 Sep 24.
PubMed 23000955Bolino CM, Bercik P. Pathogenic factors involved in the development of irritable bowel syndrome: focus on a microbial role. Infect Dis Clin North Am. 2010 Dec;24(4):961-75, ix. doi: 10.1016/j.idc.2010.07.005.
PubMed 20937460
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Cognitive-Behaviour Therapy for Irritable Bowel Syndrome and the Gut Microbiome
- ClinicalTrials.gov ID
- NCT02313246
- Acronym / sponsor ID
- IBS / CBT-IBS-2015
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator left the institution
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of a group cognitive behaviour therapy for Irritable Bowel Syndrome (IBS) in decreasing symptoms of IBS, improving quality of life, and normalizing the gut microbiome. Patients will complete an 11-week group cognitive behaviour therapy for IBS within 1 month of being deemed eligible for the study.
Detailed description
Irritable bowel syndrome (IBS) is a chronic, disabling functional gastrointestinal disorder that is characterized by abdominal pain or discomfort and a disturbance in bowel habit. Approximately five million Canadians currently suffer with this chronic illness, which can have a significant impact on work and school absenteeism, productivity, social functioning and quality of life (Fedorak et al., 2012). Although the etiology of IBS is still unclear, there is increased interest in the role of the gut-brain axis in the development and maintenance of IBS. A growing body of evidence has identified changes in the composition, temporal stability and metabolic activity of the gut microbiome in IBS (Bolino \& Bercik, 2010). Moreover, there is evidence for bidirectional communication between the gut and the brain, such that the gut microbiota appear to influence as well as be modulated by brain activity through neurohumoral mechanisms (Collins, Surette, \& Bercik, 2012).
Currently, medications are the most widely used treatment for IBS (Ford et al., 2009; Ford et al., 2014). Although there is good evidence for the effectiveness of medications in reducing IBS symptomatology and improving quality of life, these medications are also often associated with unpleasant side effects. As a result, there is a growing interest in the utilization of psychological treatments, including cognitive behaviour therapy, for IBS. Cognitive behaviour therapy is a psychotherapeutic approach that addresses maladaptive cognitive processes and behaviours in a systematic, explicit fashion. Although there is good evidence for the effectiveness of cognitive behaviour therapy for the treatment of IBS (Ford et al., 2009; Ford et al., 2014), there is a lack of research examining the mechanisms through which cognitive behaviour therapy influences symptoms of IBS.
Accordingly, the current study has three aims: 1) to evaluate the effectiveness of group cognitive behaviour therapy for IBS on IBS symptomatology and quality of life; 2) to examine whether there are any changes in the gut microbiome from pre to posttreatment; and 3) to examine whether changes in the gut microbiome following cognitive behaviour therapy mediate changes in IBS symptomatology and quality of life. The current study has the potential of increasing knowledge about the role of the gut microbiome in IBS as well as the mechanisms of cognitive behaviour therapy for IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Cognitive Behaviour Therapy | Experimental | Behavioral: Group Cognitive Behaviour TherapyPatients will complete an 11-session group cognitive behaviour therapy for IBS that will be led by two clinicians, one of whom will be a registered clinical psychologist, at the Digestive Diseases Clinic at McMaster University Medical Centre. The group cognitive behaviour therapy will include weekly 2-hour sessions for 11 weeks. Sessions will cover the following topics: psychoeducation about IBS and the role of stress in exacerbating IBS symptoms, progressive muscle relaxation, stress management, problem solving, identifying and modifying maladaptive thinking patterns, decreasing behavioural avoidance, and exposure to feared physical sensations. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with irritable bowel syndrome
- Able to commit to attending weekly 2-hour group sessions for 12 weeks
Key exclusion criteria (7 listed)
- Use of antibiotics, or probiotics during the 4-week period prior to enrolling in the study
- Changes in medications during the 4-week period prior to enrolling in the study
- Presence of a major medical illness that may change the gut microbiome (e.g., any comorbid gastroenterological, rheumatological, or immunological disorder)
- Diagnosis of a major psychiatric disorder that is likely to impede participation in group therapy (e.g., depression with active suicidality, psychosis, or gross cognitive impairment)
- Received psychotherapy for IBS within the past 5 years
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 |
|---|---|---|
| Group Cognitive Behaviour TherapyThis 11-week group treatment will cover the following topics: psychoeducation about IBS and the role of stress in exacerbating IBS symptoms, progressive muscle relaxation, stress management, problem solving, identifying and modifying maladaptive thinking patterns, decreasing behavioural avoidance, and exposure to feared physical sensations. | Behavioural | Group Cognitive Behaviour Therapy |
Primary outcome
Birmingham IBS Symptom Scale
Time frame: baseline to 11 weeks
IBS Quality of Life
Time frame: Baseline to 11 weeks
Changes in gut microbiome as assessed through analyzing fecal samples
Time frame: Baseline to 6 weeks
Changes in gut microbiome as assessed through analyzing fecal samples
Time frame: Baseline to 11 weeks
16 secondary outcomes
GI-Cognitions Questionnaire
Time frame: Baseline to 6 weeks
GI-Cognitions Questionnaire
Time frame: Baseline to 11 weeks
Visceral Sensitivity Index
Time frame: Baseline to 6 weeks
Visceral Sensitivity Index
Time frame: Baseline to 11 weeks
Visceral Sensitivity Index
Time frame: 11 weeks to 15 weeks
Hospital Anxiety and Depression Scale
Time frame: Baseline to 6 weeks
Hospital Anxiety and Depression Scale
Time frame: Baseline to 11 weeks
Penn State Worry Questionnaire
Time frame: Baseline to 6 weeks
Penn State Worry Questionnaire
Time frame: Baseline to 11 weeks
UCLA Symptom Severity Scale
Time frame: Weekly for 11 weeks
UCLA Symptom Severity Scale
Time frame: 11 weeks to 15 weeks
Irritable Bowel Syndrome Symptom Severity Scale
Time frame: Weekly for 11 weeks
Anxiety Sensitivity Index
Time frame: Baseline to 6 weeks
Anxiety Sensitivity Index
Time frame: Baseline to 11 weeks
IBS Quality of Life
Time frame: 11 weeks to 15 weeks
Birmingham IBS Severity Scale
Time frame: 11 weeks to 15 weeks
Results and safety
The study was stopped early (reason given: Principal investigator left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Results publication: PubMed 22590697Fedorak RN, Vanner SJ, Paterson WG, Bridges RJ. Canadian Digestive Health Foundation Public Impact Series 3: irritable bowel syndrome in Canada. Incidence, prevalence, and direct and indirect economic impact. Can J Gastroenterol. 2012 May;26(5):252-6. doi: 10.1155/2012/861478.
- Results publication: PubMed 19001059Ford AC, Talley NJ, Schoenfeld PS, Quigley EM, Moayyedi P. Efficacy of antidepressants and psychological therapies in irritable bowel syndrome: systematic review and meta-analysis. Gut. 2009 Mar;58(3):367-78. doi: 10.1136/gut.2008.163162. Epub 2008 Nov 10.
- Results publication: PubMed 24935275Ford AC, Quigley EM, Lacy BE, Lembo AJ, Saito YA, Schiller LR, Soffer EE, Spiegel BM, Moayyedi P. Effect of antidepressants and psychological therapies, including hypnotherapy, in irritable bowel syndrome: systematic review and meta-analysis. Am J Gastroenterol. 2014 Sep;109(9):1350-65; quiz 1366. doi: 10.1038/ajg.2014.148. Epub 2014 Jun 17.
- Results publication: PubMed 23000955Collins SM, Surette M, Bercik P. The interplay between the intestinal microbiota and the brain. Nat Rev Microbiol. 2012 Nov;10(11):735-42. doi: 10.1038/nrmicro2876. Epub 2012 Sep 24.
- Results publication: PubMed 20937460Bolino CM, Bercik P. Pathogenic factors involved in the development of irritable bowel syndrome: focus on a microbial role. Infect Dis Clin North Am. 2010 Dec;24(4):961-75, ix. doi: 10.1016/j.idc.2010.07.005.
- Individual participant dataSharing planned: No
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Irritable Bowel Syndrome (IBS)
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.
Matilda E. Nowakowski, PhD principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Cognitive Behaviour Therapy in people with Irritable Bowel Syndrome, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was stopped early (reason given: Principal investigator left the institution). Results are not available in the source record.
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?
Birmingham IBS Symptom Scale (time frame: baseline to 11 weeks). The study lists 4 primary outcomes in all. 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 NCT02313246, which also lists 5 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 25 Mar 2016.