Crohns Disease, Irritable Bowel Syndrome, Ulcerative Colitis
Conditions
Brief summary
This study aims to test, if a two-week integrative therapy in an internal medicine ward will improve symptoms, disability and quality of life in patients with inflammatory bowel disease or irritable bowel syndrome.a It shall further be tested, if those changes are associated with attitudes and experiences towards complementary and alternative medicine, anxiety, depression and stress perception as well as body awareness and responsiveness.
Detailed description
see above
Interventions
OTHERIntegrative Therapy
This group receives an integrative therapy at the Department of Internal and Integrative Medicine, i.e. a combination of conventional diagnostic and therapeutic interventions with specific naturopathic, and complementary medicine approaches, and physical therapy.
Sponsors
Universität Duisburg-Essen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD) * written informed consent
Exclusion criteria
* participation in other clinical studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms Severity IBS-SSS | 2 weeks | Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997) |
| Symptoms Severity CAI | 2 weeks | Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989) |
| Symptoms Severity CDAI | 2 weeks | Symptoms Severity assessed by Crohn Disease Activity Index (CDAI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability MYMOP | 2 weeks | Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996) |
| Quality of Life IBS-QOL | 2 weeks | Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998) |
| Quality of Life IBDQ | 2 weeks | Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007) |
| Symptoms Severity IBS-SSS | 24 weeks | Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997) |
| Body awareness BAQ | 24 weeks | Body awareness assessed by Body Awareness Questionnaire (BAQ) (Shields et al., 1989) |
| Body awareness BRS | 24 weeks | Body awareness assessed by Body Responsiveness Scale (BRS) (Daubenmier, 2005) |
| Adverse effects | 2 weeks | Number of participants with any adverse effect during the study period |
| Self efficacy questionnaire SWE | 2 weeks | Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995) |
| Symptoms Severity CAI | 24 weeks | Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989) |
| Symptoms Severity CDAI | 24 weeks | Symptoms Severity assessed by Crohn Disease Activity Index (CDAI) |
Countries
Germany
Outcome results
None listed