Clinical trial NCT02721823: Randomized Controlled Trial of Stress Reduction and Lifestyle Modification for Ulcerative Colitis
Official title: Randomized Controlled Trial on the Effect of Stress Reduction and Lifestyle Modification on Disease Activity in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Disease-specific quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: Disease-specific quality of life
timeFrame: 48 weeks
measure: Disease-specific quality of life
timeFrame: 60 weeks
measure: Disease-specific quality of life
timeFrame: 108 weeks
measure: Disease activity
timeFrame: 12 weeks
measure: Disease activity
timeFrame: 12 weeks
measure: Disease activity
timeFrame: 48 weeks
measure: Disease activity
timeFrame: 48 weeks
measure: Disease activity
timeFrame: 60 weeks
measure: Disease activity
timeFrame: 60 weeks
measure: Disease activity
timeFrame: 108 weeks
measure: Disease activity
timeFrame: 108 weeks
measure: Endoscopic index
timeFrame: 12 weeks
measure: Endoscopic index
timeFrame: 48 weeks
measure: Endoscopic index
timeFrame: 60 weeks
measure: Endoscopic index
timeFrame: 108 weeks
measure: Histology
timeFrame: 12 weeks
measure: Histology
timeFrame: 48 weeks
measure: Histology
timeFrame: 60 weeks
measure: Histology
timeFrame: 108 weeks
measure: Generic quality of life
timeFrame: 12 weeks
measure: Generic quality of life
timeFrame: 48 weeks
measure: Generic quality of life
timeFrame: 60 weeks
measure: Generic quality of life
timeFrame: 108 weeks
measure: Anxiety and depression
timeFrame: 12 weeks
measure: Anxiety and depression
timeFrame: 48 weeks
measure: Anxiety and depression
timeFrame: 60 weeks
measure: Anxiety and depression
timeFrame: 108 weeks
measure: Perceived stress
timeFrame: 12 weeks
measure: Perceived stress
timeFrame: 48 weeks
measure: Perceived stress
timeFrame: 60 weeks
measure: Perceived stress
timeFrame: 108 weeks
measure: Irritable Bowel Syndrome Symptoms
timeFrame: 12 weeks
measure: Irritable Bowel Syndrome Symptoms
timeFrame: 48 weeks
measure: Irritable Bowel Syndrome Symptoms
timeFrame: 60 weeks
measure: Irritable Bowel Syndrome Symptoms
timeFrame: 108 weeks
measure: Hemogram
timeFrame: 12 weeks
measure: Hemogram
timeFrame: 48 weeks
measure: Hemogram
timeFrame: 60 weeks
measure: Hemogram
timeFrame: 108 weeks
measure: Blood sedimentation rate
timeFrame: 12 weeks
measure: Blood sedimentation rate
timeFrame: 48 weeks
measure: Blood sedimentation rate
timeFrame: 60 weeks
measure: Blood sedimentation rate
timeFrame: 108 weeks
measure: C-reactive protein
timeFrame: 12 weeks
measure: C-reactive protein
timeFrame: 48 weeks
measure: C-reactive protein
timeFrame: 60 weeks
measure: C-reactive protein
timeFrame: 108 weeks
measure: faecal calprotectin
timeFrame: 12 weeks
measure: faecal calprotectin
timeFrame: 48 weeks
measure: faecal calprotectin
timeFrame: 60 weeks
measure: faecal calprotectin
timeFrame: 108 weeks
measure: faecal lactoferrin
timeFrame: 12 weeks
measure: faecal lactoferrin
timeFrame: 48 weeks
measure: faecal lactoferrin
timeFrame: 60 weeks
measure: faecal lactoferrin
timeFrame: 108 weeks
measure: faecal polymorphonuclear (PMN)-elastase
timeFrame: 12 weeks
measure: faecal PMN-elastase
timeFrame: 48 weeks
measure: faecal PMN-elastase
timeFrame: 60 weeks
measure: faecal PMN-elastase
timeFrame: 108 weeks
measure: faecal human beta-defensin-2 (hBD-2)
timeFrame: 12 weeks
measure: faecal hBD-2
timeFrame: 48 weeks
measure: faecal hBD-2
timeFrame: 60 weeks
measure: faecal hBD-2
timeFrame: 108 weeks
measure: Intestinal microbiota
timeFrame: 12 weeks
measure: Intestinal microbiota
timeFrame: 48 weeks
measure: Intestinal microbiota
timeFrame: 60 weeks
measure: Intestinal microbiota
timeFrame: 108 weeks
measure: Intestinal permeability
timeFrame: 12 weeks
measure: Intestinal permeability
timeFrame: 48 weeks
measure: Intestinal permeability
timeFrame: 60 weeks
measure: Intestinal permeability
timeFrame: 108 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 48 weeks
measure: Adverse events
timeFrame: 60 weeks
measure: Adverse events
timeFrame: 108 weeks
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Knappschafts Krankenhaus
state: NRW
Study officials:
affiliation: Kliniken Essen-Mitte
name: Jost Langhorst, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schlee C, Uecker C, Bauer N, Koch AK, Langhorst J. Multimodal stress reduction and lifestyle modification program for patients with ulcerative colitis: a qualitative study. BMC Complement Med Ther. 2022 Mar 8;22(1):60. doi: 10.1186/s12906-021-03478-w.