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

NCT02313246 | Terminated

• 1 other identifier: CBT-IBS-2015
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (4)

• Birmingham IBS Symptom Scale

  baseline to 11 weeks

• IBS Quality of Life

  Baseline to 11 weeks

• Changes in gut microbiome as assessed through analyzing fecal samples

  Baseline to 6 weeks

• Changes in gut microbiome as assessed through analyzing fecal samples

  Baseline to 11 weeks

Secondary Outcomes (16)

• GI-Cognitions Questionnaire

  Baseline to 6 weeks

• GI-Cognitions Questionnaire

  Baseline to 11 weeks

• Visceral Sensitivity Index

  Baseline to 6 weeks

• Visceral Sensitivity Index

  Baseline to 11 weeks

• Visceral Sensitivity Index

  11 weeks to 15 weeks

Study Arms (1)

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.

Behavioral: Group Cognitive Behaviour Therapy

Interventions

Group Cognitive Behaviour Therapy BEHAVIORAL

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.

Group Cognitive Behaviour Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (5)

• 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.

  PMID: 22590697 RESULT

• 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.

  PMID: 19001059 RESULT

• 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.

  PMID: 24935275 RESULT

• 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.

  PMID: 23000955 RESULT

• 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.

  PMID: 20937460 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Matilda E. Nowakowski, PhD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 10, 2014
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 25, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)