As part of the GW4730 project module of the Master's degree program, we are conducting a study on the influence of self-help on the psychological well-being of patients with chronic inflammatory bowel disease (IBD).

The study includes people between the ages of 18 and 65 with a medical diagnosis of Crohn's disease or ulcerative colitis who are not undergoing inpatient treatment, are not breastfeeding or are pregnant.

Here you can find our project flyer.

With your help, we can reach even more people. Therefore we ask you to forward this flyer. If you would like to distribute it, please contact us and we will send you a few printouts.

If you are between 18 and 65 years old, you can take part in the online survey using this link or the QR code in the flyer (see above). The success of the study depends on a high number of participants. The more people take part, the more meaningful the results will be. We therefore ask you to decide to take part.

Crohn's disease (MC) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD). MC is a recurrent IBD that can affect the entire digestive tract from the mouth to the anus (Ceauthier & Hornecker, 2018). In contrast, CU is limited to the colon and rectum (Hartmann, 2021). Both diseases are relapsing-remitting (Keller, 2007).

In Germany, around 322 adults per 100,000 inhabitants suffer from MC (Ng et al., 2017). The overall incidence in Germany is 6.6 new cases per 100,000 inhabitants per year. The highest incidence is between the ages of 33 and 45 (Preiß et al., 2014). Men and women are affected at roughly the same rate. The prevalence of CU in Germany is around 160 to 250/100,000 inhabitants (Manthey et al., 2021). In around 15% of cases, it is not possible to distinguish between the two diseases. As a result, unclassifiable colitis is diagnosed (Keller, 2007). The incidence of IBD is increasing worldwide and is now considered a "global emerging disease" (Manthey et al., 2021).

People with IBD have limitations in many areas of life. Due to the diverse symptoms of both types, IBD and MC, patients are often restricted in their everyday lives. The quality of life of people with MC is affected by symptoms such as chronic abdominal pain, diarrhea with blood and mucus discharge, weight loss, fever and clinical signs of bowel obstruction (Ha & Khalil, 2015). The non-specific symptoms of MC make it difficult to distinguish it from other inflammatory bowel diseases (Gomollón et al., 2017). During an attack, patients with CU often suffer from bloody and mucousy diarrhea and abdominal cramp-like pain and tenesmus (Frei, 2013). Depending on the severity and course of the disease, loss of appetite, weight loss, fatigue and loss of performance are also common consequences of an attack. In addition, anemia can also occur due to the typical numerous bloody diarrheas. Similar to MC, growth disorders are part of the symptoms in children (Frei, 2013).

The quality of life and social aspects of those affected are severely impaired by the aforementioned symptoms (Rogler et al, 2021). Patients with IBD also have great difficulty coping with everyday life in all areas of life (McMullan et al., 2017; Rogler et al., 2021; Seyedian et al., 2019). Fecal incontinence in particular is a major burden for patients with IBD due to the pain, strong urge to defecate, odor and loss of control and is accompanied by a feeling of shame and anxiety for many (Dibley & Norton, 2013). To avoid these feelings, many sufferers isolate themselves in their own homes or seek out areas that allow quick access to toilets (McMullan et al., 2017). In addition, those affected report a feeling of missing out, a reduction in their own potential and a change in social relationships due to the illness and avoidance of social interactions (Dibley & Norton, 2013; Sammut et al., 2015). A systematic review with meta-analysis by Barberio et al. (2021) also shows that people with IBD are significantly more often affected by anxiety and depression than people without IBD. Furthermore, stress in IBD and depressive symptoms in MC can have a negative impact on disease activity (Alexakis et al., 2017; Skrautvol & Nåden, 2017).

Due to the physical and psychosocial effects of IBD, comprehensive, holistic and multidisciplinary care for affected patients is an essential prerequisite for the successful management of the disease (van Erp et al., 2022). The treatment of IBD is complex because, on the one hand, the severity of the disease can vary greatly and, on the other, the challenges and needs of patients are often very different. In addition to general adequate care structures such as the provision of comprehensive information on individual disease manifestations and the timeliness, availability and regularity of medical care, individual counseling and support for patients is therefore also essential (Fiorino et al., 2020). The medical care of patients with IBD therefore requires a variety of different specialist disciplines in order to optimally guarantee the quality of treatment (Atreya, 2023). In addition to medical treatment, holistic care therefore also includes psychosocial support services for patients and their relatives.

Various associations and projects are therefore addressing the topic of self-help and attempting to provide interprofessional support to patients in coping with the disease and thus improve the quality of life of those affected. From the DCCV's point of view, the term self-help aims to provide those affected with the best possible support through reliable and continuous contact persons, such as IBD specialist assistants, while maintaining their independence. Self-help therefore means empowering people with IBD to actively deal with their own disease and make self-determined decisions for their own health. In self-help groups, those affected can discuss how to deal with the disease and support and affirm each other in order to better manage their own life situation (Sander & Kaltz, 2023).

Despite established structures and services that support patients with IBD and their relatives, current studies continue to show deficits in the psychosocial care of those affected (van Erp et al., 2022) and a high need for care by mental health professionals (Prasad et al., 2022). The mental health of patients is often not taken into account in the treatment of IBD and access to appropriate help is inadequate (Mikocka-Walus et al., 2020).

The study is conducted as a cross-sectional mixed-methods study with an explanatory design. To this end, a standardized survey will be conducted first, followed by guided interviews to explore the results in greater depth.

The ethics notification and study registration for the project were completed in August and September 2023. From October 16 to November 10 of this year, patients will be surveyed by participating in an online questionnaire. Interviews will then be conducted between November and December. The online survey will be analyzed during the same period. The qualitative analysis will be conducted from January 2024 to February 2024. The results of both analyses will be written up by the end of February.

• Alexakis, C., Kumar, S., Saxena, S., & Pollok, R. (2017). Systematic review and meta-analysis: the impact of depressive state on disease course in adult inflammatory bowel disease. Alimentary Pharmacology & Therapeutics, 46(3), 225-235. doi.org/10.1111/apt.14171
• Atreya, R. (2023). Structural organization of a CED center. In A. Sturm (Ed.), Nursing care in chronic inflammatory bowel disease: For CED continuing education and practice (pp. 229-235). Springer. doi.org/10.1007/978-3-662-64938-1_20
• Barberio, B., Zamani, M., Black, C. J., Savarino, E. V., & Ford, A. C. (2021). Prevalence of symptoms of anxiety and depression in patients with inflammatory bowel disease: a systematic review and meta-analysis. The lancet. Gastroenterology & hepatology, 6(5), 359-370. doi.org/10.1016/S2468-1253(21)00014-5
• Dibley, L., & Norton, C. (2013). Experiences of Fecal Incontinence in People with Bowel Disease: Self-reported Experiences Among a Community Sample. Inflammatory Bowel Disease, 19(7), 1450-1462. doi.org/10.1097/mib.0b013e318281327f
• Fiorino, G., Lytras, T., Younge, L., Fidalgo, C., Coenen, S., Chaparro, M. et al. (2020). Quality of care standards in inflammatory bowel diseases: A European Crohn's and Colitis Organization [ECCO] position paper. Journal of Crohn's and Colitis, 14(8), 1037-1048. doi.org/10.1093/ecco-jcc/jjaa023
• Frei, P. (2013). Diseases of the colon. In T. Lüscher & J. Steffel (Eds.), Gastrointestinal tract (pp. 161-182). Springer. doi.org/10.1007/978-3-642-29434-1_10
• Gomollón, F., Dignass, A., Annese, V., Tilg, H., Van Assche, G., Lindsay, J. O. et al. (2017). 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 1: Diagnosis and Medical Management. Journal of Crohn's & colitis, 11(1), 3-25. doi.org/10.1093/ecco-jcc/jjw168
• Ha, F., & Khalil, H. (2015). Crohn's disease: a clinical update. Therapeutic advances in gastroenterology, 8(6), 352-359. doi.org/10.1177/1756283X15592585
• Hartmann, F. (2021). Ulcerative colitis. In T. Sauerbruch (Ed.), Therapy handbook-gastroenterology and hepatology (1st ed., pp. 222-233). Elsevier GmbH. books.google.de/books; Keller, K.-M. (2007). Crohn's disease and ulcerative colitis. In M. J. Lentze, F. J. Schulte, J. Schaub & J. Spranger, Pediatrics: Principles and Practice (3rd ed., pp. 933-939). Springer. doi.org/10.1007/978-3-540-76460-1_112.
• McMullan, C., Pinkney, T. D., Jones, L. L., Magill, L., Nepogodiev, D., Pathmakanthan, S. et al. (2017). Adapting to ulcerative colitis to try to live a 'normal' life: a qualitative study of patient's experiences in the Midlands of region of England. BMJ Open, 7(8), e017544. doi.org/10.1136/bmjopen-2017-017544
• Mikocka-Walus, A., Massuger, W., Knowles, S. R., Moore, G. T., Buckton, S., Connell, W. et al. (2020). Psychological distress is highly prevalent in inflammatory bowel disease: A survey of psychological needs and attitudes. JGH Open, 4(2), 166-171. doi.org/10.1002/jgh3.12236
• Ng, S. C., Shi, H. Y., Hamidi, N., Underwood, F. E., Tang, W., Benchimol, E. I. et al. (2017). Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet, 390(10114), 2769-2778. doi.org/10.1016/S0140-6736(17)32448-0
• Preiß, J. C., Bokemeyer, B., Buhr, H. J., Dignaß, A., Häuser, W., Hartmann, F. et al. (2014). Aktualisierte S3-Leitlinie--"Diagnostik und Therapie des Morbus Crohn" 2014 [Updated German clinical practice guideline on "Diagnosis and treatment of Crohn's disease" 2014]. Journal of Gastroenterology, 52(12), 1431-1484. doi.org/10.1055/s-0034-1385199
• Rogler, G., Singh, A., Kavanaugh, A., & Rubin, D. T. (2021). Extraintestinal Manifestations of Inflammatory Bowel Disease: Current Concepts, Treatment, and Implications for Disease Management. Gastroenterology, 161(4), 1118-1132. doi.org/10.1053/j.gastro.2021.07.042
• Sammut, J., Scerri, J., & Xuereb, R. B. (2015). The lived experience of adults with ulcerative colitis. Journal of Clinical Nursing, 24(17-18), 2659-2667. doi.org/10.1111/jocn.12892
• Sander, C., & Kaltz, B. (2023). Self-help. In A. Sturm (Ed.), Nursing care for inflammatory bowel disease: For CED continuing education and practice (pp. 221-227). Springer. doi.org/10.1007/978-3-662-64938-1_19
• Skrautvol, K., & Nåden, D. (2017). Tolerance Limits, Self-understanding, and Stress Resilience in Integrative Recovery of Inflammatory Bowel Disease. Holistic Nursing Practice, 31(1), 30-41. doi.org/10.1097/hnp.0000000000000189
• van Erp, L. W., Neijenhuis, M. K., Heida, W., Derwig, J., Geleijns, C. E., Groenen, M. J. M. et al. (2022). Improving care for recently diagnosed inflammatory bowel disease patients: Lessons learned from a patient-centered, mixed-method study. Journal of Crohn's and Colitis, 16(5), 737-745. doi.org/10.1093/ecco-jcc/jjab196

Personal data is collected from you. This includes information about your inflammatory bowel disease, the use of self-help services and your psychological well-being. All personal data will be kept strictly confidential and will only be accessible to the research team.

The Institute of Social Medicine and Epidemiology has concluded a contract with LimeSurvey GmbH for commissioned data processing in order to guarantee the processing of personal data in accordance with the General Data Protection Regulation (GDPR). Computers at the University of Lübeck that allow access to the data entered are located in offices that are locked when users leave and are protected by passwords and require user authentication. Access can be tracked. The data is stored in folders that are only visible and accessible to Prof. Matthias Bethge's working group at the University of Lübeck. The network into which the computers are integrated is protected against external access and manipulation by a regularly updated firewall system. All e-mail addresses will be deleted after the study results have been sent, at the latest by 01.12.2024. The University of Lübeck will completely delete the electronically stored questionnaire data ten years after the end of the study (March 31, 2034).

All personal and personally identifiable data will be pseudonymized in the course of transcription. Following transcription, all audio data is deleted by overwriting it several times, thereby anonymizing the data. The anonymized transcripts stored on the password-protected computers will be destroyed no later than ten years after completion of the study (31.03.2034).

Participation in the online survey is voluntary. You can withdraw your participation at any time without giving reasons, even after you have given your consent. If you would like to revoke your participation at a later date, receive information about your stored data, restrict the processing of your data or exercise your right to data erasure, please contact us (E-Mail:sofia.petrak@student.uni-luebeck.de). The revocation results in the irrevocable deletion of the collected data. Deletion of the data after revocation is only possible until the data has been completely anonymized.

If you have any complaints, please contact: Unabhängiges Landeszentrum für Datenschutz Schleswig-Holstein, Holstenstraße 98, 24103 Kiel, e-mail: mail@datenschutzzentrum.de.

Responsible for this research is Prof. Dr. Matthias Bethge, University of Lübeck (e-mail: matthias.bethge@uksh.de).

If you have general questions about data protection, you can contact the data protection officer at the University of Lübeck: x-tention Informationstechnologie GmbH, Karl-Drais-Str. 4e, 86167 Augsburg, phone: +49 451 31011903m, e-mail: daten-schutz@uni-luebeck.de.

Universal Trial Number from the WHO: U1111-1293-7801

Registration number: DRKS00032536(link to trial registry entry)

There is no external funding. The research project is supervised and supported by the Institute of Social Medicine and Epidemiology, Prof. Dr. Matthias Bethge and Stella Lemke. For data protection reasons, only the computers available at the Institute are used for data processing and data analysis.

We would like to thank our module supervisor Prof. Dr. Matthias Bethge and our lecturer Stella Lemke from the bottom of our hearts for the extraordinary support and the unique opportunity they gave us to realize our great project. Your help and commitment have made our module an unforgettable experience.

If you have any further questions, please contact the research team!

• Sofia Petrak
• Prof. Dr. Matthias Bethge