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Stressin vähentäminen ja elämäntapojen muuttaminen ärtyvän suolen oireyhtymää sairastavilla potilailla

torstai 5. marraskuuta 2026 päivittänyt: Jost Langhorst, Universität Duisburg-Essen

Stressinvähennys- ja elämäntapamuutosohjelman vaikutus ärtyvän suolen oireyhtymäpotilaiden elämänlaatuun (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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

118

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Tutki yhteystietojen varmuuskopiointi

Opiskelupaikat

  • Saksa
    • Bavaria
      • Bamberg, Bavaria, Saksa, 96049
        • Rekrytointi
        • Sozialstiftung Bamberg
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 75 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Käyttäytyminen: 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.
Active Comparator: 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.
Käyttäytyminen: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Severity of IBS symptoms by IBS-SSS
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: week 12

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

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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Disease related Quality of Life by IBS-QOL
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: week 0

Number of visits
week 0
Utilization of medical services
Aikaikkuna: week 12

Number of visits
week 12
Utilization of medical services
Aikaikkuna: week 36

Number of visits
week 36
Days of work disability
Aikaikkuna: week 0

Number of days
week 0
Days of work disability
Aikaikkuna: week 12

Number of days
week 12
Days of work disability
Aikaikkuna: week 36

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

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

all adverse events
week 12
Adverse events
Aikaikkuna: week 36

all adverse events
week 36

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Universität Duisburg-Essen

Yhteistyökumppanit

Bavarian State Ministry of Health and Care

Tutkijat

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

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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