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Снижение стресса и модификация образа жизни у пациентов с синдромом раздраженного кишечника

5 ноября 2026 г. обновлено: Jost Langhorst, Universität Duisburg-Essen

Влияние программы снижения стресса и модификации образа жизни на качество жизни пациентов с синдромом раздраженного кишечника (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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

118

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Учебное резервное копирование контактов

Места учебы

  • Германия
    • Bavaria
      • Bamberg, Bavaria, Германия, 96049
        • Рекрутинг
        • Sozialstiftung Bamberg
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 75 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Поведенческий: lifestyle modification

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.
Активный компаратор: 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.
Поведенческий: waitlist control group

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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Severity of IBS symptoms by IBS-SSS
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: week 12

Rating scale from 1 (= much worse) to 5 (= much better)
week 12
overall change in health status
Временное ограничение: week 36

Rating scale from 1 (= much worse) to 5 (= much better)
week 36

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Disease related Quality of Life by IBS-QOL
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: week 0

Number of visits
week 0
Utilization of medical services
Временное ограничение: week 12

Number of visits
week 12
Utilization of medical services
Временное ограничение: week 36

Number of visits
week 36
Days of work disability
Временное ограничение: week 0

Number of days
week 0
Days of work disability
Временное ограничение: week 12

Number of days
week 12
Days of work disability
Временное ограничение: week 36

Number of days
week 36
Anxiety and depression by HADS
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: week 12

Qualitative interviews for gaining further insights into patients experiences
week 12
Adverse events
Временное ограничение: week 12

all adverse events
week 12
Adverse events
Временное ограничение: week 36

all adverse events
week 36

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Universität Duisburg-Essen

Соавторы

Bavarian State Ministry of Health and Care

Следователи

  • Главный следователь: Jost Langhorst, Prof. Dr., University of Duisburg-Essen/Sozialstiftung Bamberg

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

6 марта 2024 г.

Первичное завершение (Оцененный)

31 декабря 2026 г.

Завершение исследования (Оцененный)

31 августа 2027 г.

Даты регистрации исследования

Первый отправленный

10 ноября 2023 г.

Впервые представлено, что соответствует критериям контроля качества

17 ноября 2023 г.

Первый опубликованный (Действительный)

22 ноября 2023 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

6 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

5 ноября 2026 г.

Последняя проверка

1 октября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 23065

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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