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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

lifestyle-modification

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No