Randomized Controlled Trial of Stress Reduction and Lifestyle Modification for Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— MBMCol  

Official title:

Randomized Controlled Trial on the Effect of Stress Reduction and Lifestyle Modification on Disease Activity in Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02721823
• Other study ID #: 15-6554-BO
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2016
• Last updated: May 9, 2017
• Start date: March 2016
• Est. completion date: October 2019

Study information

• Verified date: May 2017
• Source: Universität Duisburg-Essen
• Contact: Jost Langhorst, Prof. Dr. med.
• Phone: 020117425012
• Email: j.langhorst[@]kliniken-essen-mitte.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with ulcerative colitis often suffer significant limitations to their quality of life, which are also conditioned by particular stress and psychosocial accompanying symptoms of the disease. A multimodal program for stress-reduction and lifestyle-modification has been shown to be effective in promoting the quality of life. The study will examine the promotion of the quality of life of patients with ulcerative colitis and the positive Influence on stress, psychological symptoms and physiological parameters. 92 patients with ulcerative colitis will be randomized in an Intervention group and a control group for 10 weeks. The primary outcome is the disease-specific quality of life, the secondary outcomes are stress, psychological symptoms, inflammatory parameters, disease activity parameters, bowel parameter and the microbiome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 to 75 years

• diagnosis of ulcerative colitis

• Currently in remission, remission not longer than 12 months

• limited quality of life or increased subjective stress level

Exclusion Criteria:

• Infectious or chronic active ulcerative colitis

• Taking glucocorticoids or immunosuppressants within the last 3 months, except stable medication using azathioprine

• colectomy

• serious psychological disorder (for example: major depression, addiction, schizophrenia)

• serious comorbid somatic disease (for example: diabetes mellitus, oncological disease)

• pregnancy

• participation in stress reduction program or clinical studies to psychological interventions

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Behavioral:
• lifestyle-modification
The group intervention is carried out once a week for 10 weeks for a total of 60 hours with elements of mindfulness-based stress reduction (MBSR) and further process of the mind / body medicine. In this project, this program will be adapted to the specific needs of colitis patients.
• Control group
Participants in this group receive a one-time education unit within the scope of 3 hours on the influence of lifestyle factors on the disease, also self-help materials for independent training offered. Following the follow-up measure also this group is given the opportunity to participate in the multimodal stress reduction- and lifestyle modification program.

Locations

Country	Name	City	State
Germany	Kliniken Essen-Mitte, Knappschafts Krankenhaus	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-specific quality of life	Inflammatory Bowel Disease Questionnaire (IBD-Q)	12 weeks
Secondary	Disease-specific quality of life	Inflammatory Bowel Disease Questionnaire (IBD-Q)	48 weeks
Secondary	Disease-specific quality of life	Inflammatory Bowel Disease Questionnaire (IBD-Q)	60 weeks
Secondary	Disease-specific quality of life	Inflammatory Bowel Disease Questionnaire (IBD-Q)	108 weeks
Secondary	Disease activity	Mayo Disease Activity Index (Mayo Score)	12 weeks
Secondary	Disease activity	Clinical Activity Index (CAI)	12 weeks
Secondary	Disease activity	Mayo Disease Activity Index (Mayo Score)	48 weeks
Secondary	Disease activity	Clinical Activity Index (CAI)	48 weeks
Secondary	Disease activity	Mayo Disease Activity Index (Mayo Score)	60 weeks
Secondary	Disease activity	Clinical Activity Index (CAI)	60 weeks
Secondary	Disease activity	Mayo Disease Activity Index (Mayo Score)	108 weeks
Secondary	Disease activity	Clinical Activity Index(CAI)	108 weeks
Secondary	Endoscopic index	Endoscopic-Index (sigmoidoscopy)	12 weeks
Secondary	Endoscopic index	Endoscopic-Index (sigmoidoscopy)	48 weeks
Secondary	Endoscopic index	Endoscopic-Index (sigmoidoscopy))	60 weeks
Secondary	Endoscopic index	Endoscopic-Index (sigmoidoscopy)	108 weeks
Secondary	Histology	Riley Score	12 weeks
Secondary	Histology	Riley Score	48 weeks
Secondary	Histology	Riley Score	60 weeks
Secondary	Histology	Riley Score	108 weeks
Secondary	Generic quality of life	Short Form (SF) -36 (items) health survey	12 weeks
Secondary	Generic quality of life	SF-36 health survey	48 weeks
Secondary	Generic quality of life	SF-36 health survey	60 weeks
Secondary	Generic quality of life	SF-36 health survey	108 weeks
Secondary	Anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	12 weeks
Secondary	Anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	48 weeks
Secondary	Anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	60 weeks
Secondary	Anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	108 weeks
Secondary	Perceived stress	Perceived Stress Scale (PSS)	12 weeks
Secondary	Perceived stress	Perceived Stress Scale (PSS)	48 weeks
Secondary	Perceived stress	Perceived Stress Scale (PSS)	60 weeks
Secondary	Perceived stress	Perceived Stress Scale (PSS)	108 weeks
Secondary	Irritable Bowel Syndrome Symptoms	IBS Severity Scoring System (IBS-SSS)	12 weeks
Secondary	Irritable Bowel Syndrome Symptoms	IBS Severity Scoring System (IBS-SSS)	48 weeks
Secondary	Irritable Bowel Syndrome Symptoms	IBS Severity Scoring System (IBS-SSS)	60 weeks
Secondary	Irritable Bowel Syndrome Symptoms	IBS Severity Scoring System (IBS-SSS)	108 weeks
Secondary	Hemogram	leukocyte, hemoglobin, hematocrit, platelet	12 weeks
Secondary	Hemogram	leukocyte, hemoglobin, hematocrit, platelet	48 weeks
Secondary	Hemogram	leukocyte, hemoglobin, hematocrit, platelet	60 weeks
Secondary	Hemogram	leukocyte, hemoglobin, hematocrit, platelet	108 weeks
Secondary	Blood sedimentation rate		12 weeks
Secondary	Blood sedimentation rate		48 weeks
Secondary	Blood sedimentation rate		60 weeks
Secondary	Blood sedimentation rate		108 weeks
Secondary	C-reactive protein		12 weeks
Secondary	C-reactive protein		48 weeks
Secondary	C-reactive protein		60 weeks
Secondary	C-reactive protein		108 weeks
Secondary	faecal calprotectin		12 weeks
Secondary	faecal calprotectin		48 weeks
Secondary	faecal calprotectin		60 weeks
Secondary	faecal calprotectin		108 weeks
Secondary	faecal lactoferrin		12 weeks
Secondary	faecal lactoferrin		48 weeks
Secondary	faecal lactoferrin		60 weeks
Secondary	faecal lactoferrin		108 weeks
Secondary	faecal polymorphonuclear (PMN)-elastase	faecal polymorphonuclear elastase	12 weeks
Secondary	faecal PMN-elastase	faecal polymorphonuclear elastase	48 weeks
Secondary	faecal PMN-elastase	faecal polymorphonuclear elastase	60 weeks
Secondary	faecal PMN-elastase	faecal polymorphonuclear elastase	108 weeks
Secondary	faecal human beta-defensin-2 (hBD-2)		12 weeks
Secondary	faecal hBD-2	human beta-defensin-2	48 weeks
Secondary	faecal hBD-2	human beta-defensin-2	60 weeks
Secondary	faecal hBD-2	human beta-defensin-2	108 weeks
Secondary	Intestinal microbiota	High-throughput 16S ribosomal ribonucleic acid (rRNA) gene sequencing	12 weeks
Secondary	Intestinal microbiota	High-throughput 16S rRNA gene sequencing	48 weeks
Secondary	Intestinal microbiota	High-throughput 16S rRNA gene sequencing	60 weeks
Secondary	Intestinal microbiota	High-throughput 16S rRNA gene sequencing	108 weeks
Secondary	Intestinal permeability	LactoseMonitol	12 weeks
Secondary	Intestinal permeability	LactoseMonitol	48 weeks
Secondary	Intestinal permeability	LactoseMonitol	60 weeks
Secondary	Intestinal permeability	LactoseMonitol	108 weeks
Secondary	Adverse events		12 weeks
Secondary	Adverse events		48 weeks
Secondary	Adverse events		60 weeks
Secondary	Adverse events		108 weeks