Integrative Gastroenterology - an Observational Trial

Study Overview
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Brief Summary
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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
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see above

Official Title
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Integrative Therapy in Gastroenterology - a Prospective Observational Trial in a Department of Internal and Integrative Medicine

Conditions
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Crohns Disease, Ulcerative Colitis, Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Integrative Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Integrative Therapy<br>This group receives and 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. Patients are admitted to the hospital ward for 14 days. | Other: Integrative Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms Severity IBS-SSS | Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997) | 2 weeks | 
| Symptoms Severity CAI | Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989) | 2 weeks | 
| Symptoms Severity CDAI | Symptoms Severity assessed by Crohn Disease Activity Index (CDAI) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms Severity IBS-SSS | Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997) | 24 weeks | 
| Symptoms Severity CAI | Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989) | 24 weeks | 
| Symptoms Severity CDAI | Symptoms Severity assessed by Crohn Disease Activity Index (CDAI) | 24 weeks | 
| Disability MYMOP | Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996) | 2 weeks | 
| Disability MYMOP | Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996) | 24 weeks | 
| Quality of Life IBS-QOL | Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998) | 2 weeks | 
| Quality of Life IBS-QOL | Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998) | 24 weeks | 
| Quality of Life IBDQ | Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007) | 2 weeks | 
| Quality of Life IBDQ | Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007) | 24 weeks | 
| Self efficacy questionnaire SWE | Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995) | 2 weeks | 
| Self efficacy questionnaire SWE | Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995) | 24 weeks | 
| Body awareness BAQ | Body awareness assessed by Body Awareness Questionnaire (BAQ) (Shields et al., 1989) | 24 weeks | 
| Body awareness BRS | Body awareness assessed by Body Responsiveness Scale (BRS) (Daubenmier, 2005) | 24 weeks | 
| Adverse effects | Number of participants with any adverse effect during the study period | 2 weeks |