Redução do estresse e modificação do estilo de vida em pacientes com síndrome do intestino irritável
Efeito de um programa de redução do estresse e modificação do estilo de vida na qualidade de vida de pacientes com síndrome do intestino irritável (MBM IBS)
In the planned efficacy study, a prospective randomized controlled trial will be conducted to investigate the extent to which a multimodal stress reduction and lifestyle modification program can be reflected in patients with irritable bowel syndrome (IBS) within the framework of a clinical study. For this purpose, 118 patients with IBS will be enrolled in a clinical study. The intervention group will participate in a partial outpatient multimodal stress reduction and lifestyle modification program over 10 weeks, while the waitlist control group will only receive an educational session and written information on treatment and self-help options. The primary research question encompasses the examination of the program's impact on the severity of symptoms associated with irritable bowel syndrome (measured with the IBS-Symptom Severity Scale [IBS-SSS]) and additionally its influence on quality of life, stress, and mental well-being. Another aspect of the study is the utilization of medical services (e.g., comparing the number of doctor visits; intake of prescribed and over-the-counter medications). Additionally, a comparison of days of work disability will be conducted.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The intervention is a 10-week multimodal stress reduction and lifestyle modification program consisting of 10 sessions, each lasting 6 hours. In groups of around 10 individuals, patients are comprehensively trained on the interplay between lifestyle and health, stress management, moderate physical activity (including yoga and Tai Chi), a Mediterranean diet, and self-help strategies. Successfully tested in two pilot studies, the program has evolved over 15 years and gained clinical experience in chronic inflammatory bowel diseases. It is now being applied to patients with irritable bowel syndrome (IBS).
Built on concepts like the Mind-Body Program and mindfulness-based stress reduction, the intervention incorporates elements from salutogenic and transtheoretical models and psychotherapeutic approaches.
Few integrative medicine approaches for IBS have undergone rigorous evaluation. IBS patients often experience reduced quality of life due to stress and psychosocial symptoms. The program, proven effective in inflammatory bowel diseases, covers stress reduction, dietary improvement, physical activity promotion, self-care applications, coping strategy training, and naturopathic treatments. Medically supervised, the group setting aims to enhance the intervention's impact through mutual support. Practical skills are demonstrated, and the goal is to empower patients for active, responsible, long-term management.
Participants in the waitlist control group receive a 1,5-hour educational session on lifestyle factors' influence and self-help materials. After week 36 measurements, they are offered participation in the multimodal program.
Questionnaires, a diary, and interviews will measure the outcomes of the study. Sociodemographics will be collected.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Sandra Utz, PhD
- Número de telefone: 16926 +49 951 503
- E-mail: sandra.utz@sozialstiftung-bamberg.de
Estude backup de contato
- Nome: Christine Uecker
- Número de telefone: 16932 +49 951 503
- E-mail: christine.uecker@sozialstiftung-bamberg.de
Locais de estudo
-
-
Bavaria
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Bamberg, Bavaria, Alemanha, 96049
- Recrutamento
- Sozialstiftung Bamberg
-
Contato:
- Jost Langhorst, Prof. Dr.
- Número de telefone: 11650 +49 951 503
- E-mail: FIGN@sozialstiftung-bamberg.de
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- confirmed diagnosis of irritable bowel syndrome (IBS with diarrhea, IBS with constipation, mixed-type IBS, or unspecified IBS); IBS-SSS Score > 75
Exclusion Criteria:
- Severe mental illness (e.g., clinically significant depression, substance use disorder, schizophrenia)
- Severe comorbid somatic illness (e.g., oncological disease)
- Pregnancy
- Participation in other stress reduction programs or clinical studies on psychological interventions
- Known intolerances (fructose, lactose), celiac disease, etc.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: intervention group
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. |
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 mind / body medicine. In this project, this program will be adapted to the specific needs of irritable bowel syndrome patients. |
|
Comparador Ativo: waitlist control group
A unique education unit within the scope of 1,5 hours on the influence of lifestyle factors on the disease and self-help materials for the independent training. After the follow-up measurement opportunity to participate in the program. |
Participants in this group receive a one-time education unit within the scope of 1,5 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Severity of IBS symptoms by IBS-SSS
Prazo: week 0
|
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS |
week 0
|
|
Severity of IBS symptoms by IBS-SSS
Prazo: week 12
|
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS |
week 12
|
|
Severity of IBS symptoms by IBS-SSS
Prazo: week 36
|
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS |
week 36
|
|
overall change in health status
Prazo: week 12
|
Rating scale from 1 (= much worse) to 5 (= much better) |
week 12
|
|
overall change in health status
Prazo: week 36
|
Rating scale from 1 (= much worse) to 5 (= much better) |
week 36
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Disease related Quality of Life by IBS-QOL
Prazo: week 0
|
The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. 34 items with a 5-point response scale from 1 (=not at all) to 5 (= Extremely/a great deal); 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. |
week 0
|
|
Disease related Quality of Life by IBS-QOL
Prazo: week 12
|
The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. 34 items with a 5-point response scale from 1 (=not at all) to 5 (= Extremely/a great deal); 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. |
week 12
|
|
Disease related Quality of Life by IBS-QOL
Prazo: week 36
|
The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. 34 items with a 5-point response scale from 1 (=not at all) to 5 (= Extremely/a great deal); 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. |
week 36
|
|
General Quality of Life by EQ-5D-SL
Prazo: week 0
|
The EQ-5D assesses health status in terms of five dimensions of health (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. 5-point response-scale from 1 (=not /no problems) to 5 (=unable to [mobility, self-care, usual activities]/extreme [pain/depression]/extremely [anxiety/depression]); result: 5-digit health status profile that represents that person's level of reported problems on the five EQ-5D health dimensions |
week 0
|
|
General Quality of Life by EQ-5D-SL
Prazo: week 12
|
The EQ-5D assesses health status in terms of five dimensions of health (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. 5-point response-scale from 1 (=not /no problems) to 5 (=unable to [mobility, self-care, usual activities]/extreme [pain/depression]/extremely [anxiety/depression]); result: 5-digit health status profile that represents that person's level of reported problems on the five EQ-5D health dimensions |
week 12
|
|
General Quality of Life by EQ-5D-SL
Prazo: week 36
|
The EQ-5D assesses health status in terms of five dimensions of health (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. 5-point response-scale from 1 (=not /no problems) to 5 (=unable to [mobility, self-care, usual activities]/extreme [pain/depression]/extremely [anxiety/depression]); result: 5-digit health status profile that represents that person's level of reported problems on the five EQ-5D health dimensions |
week 36
|
|
Stress: Perceived Stress (PSS-10)
Prazo: week 0
|
Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points |
week 0
|
|
Stress: Perceived Stress (PSS-10)
Prazo: week 12
|
Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points |
week 12
|
|
Stress: Perceived Stress (PSS-10)
Prazo: week 36
|
Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points |
week 36
|
|
Stress: Coping Strategies (CISS)
Prazo: week 0
|
Short version of the Coping Inventory for Stressful Situations (24 items); Rating on a five-step scale from 1 (= not at all) to 5 (= very much); sum score for each coping strategy; higher scores indicate a greater use of that particular coping strategy |
week 0
|
|
Stress: Coping Strategies (CISS)
Prazo: week 12
|
Short version of the Coping Inventory for Stressful Situations (24 items); Rating on a five-step scale from 1 (= not at all) to 5 (= very much); sum score for each coping strategy; higher scores indicate a greater use of that particular coping strategy |
week 12
|
|
Stress: Coping Strategies (CISS)
Prazo: week 36
|
Short version of the Coping Inventory for Stressful Situations (24 items); Rating on a five-step scale from 1 (= not at all) to 5 (= very much); sum score for each coping strategy; higher scores indicate a greater use of that particular coping strategy |
week 36
|
|
Core Self-Evaluation by CSES
Prazo: week 0
|
Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person |
week 0
|
|
Core Self-Evaluation by CSES
Prazo: week 12
|
Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person |
week 12
|
|
Core Self-Evaluation by CSES
Prazo: week 36
|
Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person |
week 36
|
|
Utilization of medical services
Prazo: week 0
|
Number of visits |
week 0
|
|
Utilization of medical services
Prazo: week 12
|
Number of visits |
week 12
|
|
Utilization of medical services
Prazo: week 36
|
Number of visits |
week 36
|
|
Days of work disability
Prazo: week 0
|
Number of days |
week 0
|
|
Days of work disability
Prazo: week 12
|
Number of days |
week 12
|
|
Days of work disability
Prazo: week 36
|
Number of days |
week 36
|
|
Anxiety and depression by HADS
Prazo: week 0
|
Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety. |
week 0
|
|
Anxiety and depression by HADS
Prazo: week 12
|
Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety. |
week 12
|
|
Anxiety and depression by HADS
Prazo: week 36
|
Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety. |
week 36
|
|
Qualitative Interviews
Prazo: week 12
|
Qualitative interviews for gaining further insights into patients experiences |
week 12
|
|
Adverse events
Prazo: week 12
|
all adverse events |
week 12
|
|
Adverse events
Prazo: week 36
|
all adverse events |
week 36
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jost Langhorst, Prof. Dr., University of Duisburg-Essen/Sozialstiftung Bamberg
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 23065
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