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

May 9, 2017 updated by: Jost Langhorst, Universität Duisburg-Essen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: lifestyle-modification
Once a week for 10 weeks with a circumference of 60 hours with mindfulness-based stress reduction and further process of the Mind / body medicine.
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.
ACTIVE_COMPARATOR: control group
A unique education unit within the scope of 3 hours on the influence of lifestyle factors on the disease and self-help materials for the independent training.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease-specific quality of life
Time Frame: 12 weeks
Inflammatory Bowel Disease Questionnaire (IBD-Q)
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 12 weeks
12 weeks
Adverse events
Time Frame: 48 weeks
48 weeks
C-reactive protein
Time Frame: 12 weeks
12 weeks
Disease-specific quality of life
Time Frame: 48 weeks
Inflammatory Bowel Disease Questionnaire (IBD-Q)
48 weeks
Disease-specific quality of life
Time Frame: 60 weeks
Inflammatory Bowel Disease Questionnaire (IBD-Q)
60 weeks
Disease-specific quality of life
Time Frame: 108 weeks
Inflammatory Bowel Disease Questionnaire (IBD-Q)
108 weeks
Disease activity
Time Frame: 12 weeks
Mayo Disease Activity Index (Mayo Score)
12 weeks
Disease activity
Time Frame: 12 weeks
Clinical Activity Index (CAI)
12 weeks
Disease activity
Time Frame: 48 weeks
Mayo Disease Activity Index (Mayo Score)
48 weeks
Disease activity
Time Frame: 48 weeks
Clinical Activity Index (CAI)
48 weeks
Disease activity
Time Frame: 60 weeks
Mayo Disease Activity Index (Mayo Score)
60 weeks
Disease activity
Time Frame: 60 weeks
Clinical Activity Index (CAI)
60 weeks
Disease activity
Time Frame: 108 weeks
Mayo Disease Activity Index (Mayo Score)
108 weeks
Disease activity
Time Frame: 108 weeks
Clinical Activity Index(CAI)
108 weeks
Endoscopic index
Time Frame: 12 weeks
Endoscopic-Index (sigmoidoscopy)
12 weeks
Endoscopic index
Time Frame: 48 weeks
Endoscopic-Index (sigmoidoscopy)
48 weeks
Endoscopic index
Time Frame: 60 weeks
Endoscopic-Index (sigmoidoscopy))
60 weeks
Endoscopic index
Time Frame: 108 weeks
Endoscopic-Index (sigmoidoscopy)
108 weeks
Histology
Time Frame: 12 weeks
Riley Score
12 weeks
Histology
Time Frame: 48 weeks
Riley Score
48 weeks
Histology
Time Frame: 60 weeks
Riley Score
60 weeks
Histology
Time Frame: 108 weeks
Riley Score
108 weeks
Generic quality of life
Time Frame: 12 weeks
Short Form (SF) -36 (items) health survey
12 weeks
Generic quality of life
Time Frame: 48 weeks
SF-36 health survey
48 weeks
Generic quality of life
Time Frame: 60 weeks
SF-36 health survey
60 weeks
Generic quality of life
Time Frame: 108 weeks
SF-36 health survey
108 weeks
Anxiety and depression
Time Frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
12 weeks
Anxiety and depression
Time Frame: 48 weeks
Hospital Anxiety and Depression Scale (HADS)
48 weeks
Anxiety and depression
Time Frame: 60 weeks
Hospital Anxiety and Depression Scale (HADS)
60 weeks
Anxiety and depression
Time Frame: 108 weeks
Hospital Anxiety and Depression Scale (HADS)
108 weeks
Perceived stress
Time Frame: 12 weeks
Perceived Stress Scale (PSS)
12 weeks
Perceived stress
Time Frame: 48 weeks
Perceived Stress Scale (PSS)
48 weeks
Perceived stress
Time Frame: 60 weeks
Perceived Stress Scale (PSS)
60 weeks
Perceived stress
Time Frame: 108 weeks
Perceived Stress Scale (PSS)
108 weeks
Irritable Bowel Syndrome Symptoms
Time Frame: 12 weeks
IBS Severity Scoring System (IBS-SSS)
12 weeks
Irritable Bowel Syndrome Symptoms
Time Frame: 48 weeks
IBS Severity Scoring System (IBS-SSS)
48 weeks
Irritable Bowel Syndrome Symptoms
Time Frame: 60 weeks
IBS Severity Scoring System (IBS-SSS)
60 weeks
Irritable Bowel Syndrome Symptoms
Time Frame: 108 weeks
IBS Severity Scoring System (IBS-SSS)
108 weeks
Hemogram
Time Frame: 12 weeks
leukocyte, hemoglobin, hematocrit, platelet
12 weeks
Hemogram
Time Frame: 48 weeks
leukocyte, hemoglobin, hematocrit, platelet
48 weeks
Hemogram
Time Frame: 60 weeks
leukocyte, hemoglobin, hematocrit, platelet
60 weeks
Hemogram
Time Frame: 108 weeks
leukocyte, hemoglobin, hematocrit, platelet
108 weeks
Blood sedimentation rate
Time Frame: 12 weeks
12 weeks
Blood sedimentation rate
Time Frame: 48 weeks
48 weeks
Blood sedimentation rate
Time Frame: 60 weeks
60 weeks
Blood sedimentation rate
Time Frame: 108 weeks
108 weeks
C-reactive protein
Time Frame: 48 weeks
48 weeks
C-reactive protein
Time Frame: 60 weeks
60 weeks
C-reactive protein
Time Frame: 108 weeks
108 weeks
faecal calprotectin
Time Frame: 12 weeks
12 weeks
faecal calprotectin
Time Frame: 48 weeks
48 weeks
faecal calprotectin
Time Frame: 60 weeks
60 weeks
faecal calprotectin
Time Frame: 108 weeks
108 weeks
faecal lactoferrin
Time Frame: 12 weeks
12 weeks
faecal lactoferrin
Time Frame: 48 weeks
48 weeks
faecal lactoferrin
Time Frame: 60 weeks
60 weeks
faecal lactoferrin
Time Frame: 108 weeks
108 weeks
faecal polymorphonuclear (PMN)-elastase
Time Frame: 12 weeks
faecal polymorphonuclear elastase
12 weeks
faecal PMN-elastase
Time Frame: 48 weeks
faecal polymorphonuclear elastase
48 weeks
faecal PMN-elastase
Time Frame: 60 weeks
faecal polymorphonuclear elastase
60 weeks
faecal PMN-elastase
Time Frame: 108 weeks
faecal polymorphonuclear elastase
108 weeks
faecal human beta-defensin-2 (hBD-2)
Time Frame: 12 weeks
12 weeks
faecal hBD-2
Time Frame: 48 weeks
human beta-defensin-2
48 weeks
faecal hBD-2
Time Frame: 60 weeks
human beta-defensin-2
60 weeks
faecal hBD-2
Time Frame: 108 weeks
human beta-defensin-2
108 weeks
Intestinal microbiota
Time Frame: 12 weeks
High-throughput 16S ribosomal ribonucleic acid (rRNA) gene sequencing
12 weeks
Intestinal microbiota
Time Frame: 48 weeks
High-throughput 16S rRNA gene sequencing
48 weeks
Intestinal microbiota
Time Frame: 60 weeks
High-throughput 16S rRNA gene sequencing
60 weeks
Intestinal microbiota
Time Frame: 108 weeks
High-throughput 16S rRNA gene sequencing
108 weeks
Intestinal permeability
Time Frame: 12 weeks
LactoseMonitol
12 weeks
Intestinal permeability
Time Frame: 48 weeks
LactoseMonitol
48 weeks
Intestinal permeability
Time Frame: 60 weeks
LactoseMonitol
60 weeks
Intestinal permeability
Time Frame: 108 weeks
LactoseMonitol
108 weeks
Adverse events
Time Frame: 60 weeks
60 weeks
Adverse events
Time Frame: 108 weeks
108 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universität Duisburg-Essen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jost Langhorst, Prof. Dr. med., Kliniken Essen-Mitte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-6554-BO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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