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

Irritable Bowel Syndrome Clinical Trial

— IBS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02313246
• Other study ID #: CBT-IBS-2015
• Status: Terminated
• Phase: N/A
• First received: December 5, 2014
• Last updated: March 24, 2016
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical 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. Patients will complete an 11-week group cognitive behaviour therapy for IBS within 1 month of being deemed eligible for the study.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Group Cognitive Behaviour Therapy
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.

Locations

Country	Name	City	State
Canada	McMaster University Medical Centre	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. Review. — View 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. Review. — View 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. — View 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 Gastroe — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birmingham IBS Symptom Scale		baseline to 11 weeks	No
Primary	IBS Quality of Life		Baseline to 11 weeks	No
Primary	Changes in gut microbiome as assessed through analyzing fecal samples		Baseline to 6 weeks	No
Primary	Changes in gut microbiome as assessed through analyzing fecal samples		Baseline to 11 weeks	No
Secondary	GI-Cognitions Questionnaire		Baseline to 6 weeks	No
Secondary	GI-Cognitions Questionnaire		Baseline to 11 weeks	No
Secondary	Visceral Sensitivity Index		Baseline to 6 weeks	No
Secondary	Visceral Sensitivity Index		Baseline to 11 weeks	No
Secondary	Visceral Sensitivity Index		11 weeks to 15 weeks	No
Secondary	Hospital Anxiety and Depression Scale		Baseline to 6 weeks	No
Secondary	Hospital Anxiety and Depression Scale		Baseline to 11 weeks	No
Secondary	Penn State Worry Questionnaire		Baseline to 6 weeks	No
Secondary	Penn State Worry Questionnaire		Baseline to 11 weeks	No
Secondary	UCLA Symptom Severity Scale		Weekly for 11 weeks	No
Secondary	UCLA Symptom Severity Scale		11 weeks to 15 weeks	No
Secondary	Irritable Bowel Syndrome Symptom Severity Scale		Weekly for 11 weeks	No
Secondary	Anxiety Sensitivity Index		Baseline to 6 weeks	No
Secondary	Anxiety Sensitivity Index		Baseline to 11 weeks	No
Secondary	IBS Quality of Life		11 weeks to 15 weeks	No
Secondary	Birmingham IBS Severity Scale		11 weeks to 15 weeks	No