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A Pilot Study of Cognitive-Behaviour Therapy for Irritable Bowel Syndrome and the Gut Microbiome (IBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group Cognitive Behaviour Therapy
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with irritable bowel syndrome
  • Able to commit to attending weekly 2-hour group sessions for 12 weeks

Exclusion Criteria:

  • 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

Sites / Locations

  • McMaster University Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group Cognitive Behaviour Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Birmingham IBS Symptom Scale
IBS Quality of Life
Changes in gut microbiome as assessed through analyzing fecal samples
Changes in gut microbiome as assessed through analyzing fecal samples

Secondary Outcome Measures

GI-Cognitions Questionnaire
GI-Cognitions Questionnaire
Visceral Sensitivity Index
Visceral Sensitivity Index
Visceral Sensitivity Index
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale
Penn State Worry Questionnaire
Penn State Worry Questionnaire
UCLA Symptom Severity Scale
UCLA Symptom Severity Scale
Irritable Bowel Syndrome Symptom Severity Scale
Anxiety Sensitivity Index
Anxiety Sensitivity Index
IBS Quality of Life
Birmingham IBS Severity Scale

Full Information

First Posted
December 5, 2014
Last Updated
March 24, 2016
Sponsor
Hamilton Health Sciences Corporation
Collaborators
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT02313246
Brief Title
A Pilot Study of Cognitive-Behaviour Therapy for Irritable Bowel Syndrome and the Gut Microbiome
Acronym
IBS
Official Title
A Pilot Study of Cognitive-Behaviour Therapy for Irritable Bowel Syndrome and the Gut Microbiome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Principal investigator left the institution
Study Start Date
August 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Cognitive Behaviour Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Cognitive Behaviour Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Birmingham IBS Symptom Scale
Time Frame
baseline to 11 weeks
Title
IBS Quality of Life
Time Frame
Baseline to 11 weeks
Title
Changes in gut microbiome as assessed through analyzing fecal samples
Time Frame
Baseline to 6 weeks
Title
Changes in gut microbiome as assessed through analyzing fecal samples
Time Frame
Baseline to 11 weeks
Secondary Outcome Measure Information:
Title
GI-Cognitions Questionnaire
Time Frame
Baseline to 6 weeks
Title
GI-Cognitions Questionnaire
Time Frame
Baseline to 11 weeks
Title
Visceral Sensitivity Index
Time Frame
Baseline to 6 weeks
Title
Visceral Sensitivity Index
Time Frame
Baseline to 11 weeks
Title
Visceral Sensitivity Index
Time Frame
11 weeks to 15 weeks
Title
Hospital Anxiety and Depression Scale
Time Frame
Baseline to 6 weeks
Title
Hospital Anxiety and Depression Scale
Time Frame
Baseline to 11 weeks
Title
Penn State Worry Questionnaire
Time Frame
Baseline to 6 weeks
Title
Penn State Worry Questionnaire
Time Frame
Baseline to 11 weeks
Title
UCLA Symptom Severity Scale
Time Frame
Weekly for 11 weeks
Title
UCLA Symptom Severity Scale
Time Frame
11 weeks to 15 weeks
Title
Irritable Bowel Syndrome Symptom Severity Scale
Time Frame
Weekly for 11 weeks
Title
Anxiety Sensitivity Index
Time Frame
Baseline to 6 weeks
Title
Anxiety Sensitivity Index
Time Frame
Baseline to 11 weeks
Title
IBS Quality of Life
Time Frame
11 weeks to 15 weeks
Title
Birmingham IBS Severity Scale
Time Frame
11 weeks to 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with irritable bowel syndrome Able to commit to attending weekly 2-hour group sessions for 12 weeks Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matilda E. Nowakowski, PhD
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22590697
Citation
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.
Results Reference
result
PubMed Identifier
19001059
Citation
Ford 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 Reference
result
PubMed Identifier
24935275
Citation
Ford 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 Reference
result
PubMed Identifier
23000955
Citation
Collins 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 Reference
result
PubMed Identifier
20937460
Citation
Bolino 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.
Results Reference
result

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A Pilot Study of Cognitive-Behaviour Therapy for Irritable Bowel Syndrome and the Gut Microbiome

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