A Well-Being Intervention for People With IBS
9 сентября 2026 г. обновлено: University of Wisconsin, Madison
The purpose of this randomized behavioral clinical trial is to examine whether a well-being intervention can improve both psychological well-being and physical outcomes in adults with Irritable Bowel Syndrome (IBS).
The study aims to assess whether this intervention decreases anger, anxiety, and depression; increases self-esteem, empathy, and hope; and improves quality of life indicators such as IBS symptom severity, sleep quality, fatigue, and diet.
Participants can expect to be on study for up to 9 months.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Подробное описание
This study consists of two phases:
Study 1 (Screening and Baseline Assessment):
Participants who self-identify as having been diagnosed with IBS and receive care at the University of Wisconsin (UW) Digestive Health Center will complete a battery of self-report questionnaires assessing well-being, anger, anxiety, depression, self-esteem, empathy, hope, sleep quality, fatigue, diet, and IBS symptom severity.
Study 2 (Intervention Phase - registered here):
Eligible participants will be randomized to either an experimental well-being intervention or a waitlist control condition. Participants assigned to the waitlist control condition will not receive the intervention during the initial intervention period but will complete all scheduled assessments. After completion of the first post-test assessment, waitlist participants will receive the same 15-session well-being intervention (crossover design).
The intervention will be held once a week for 15 weeks, lasting approximately one hour per session, conducted in a private meeting room at the Digestive Health Center. Sessions focus on emotional awareness, perspective-taking, and developing the capacity to overcome hurt and resentment toward a person who acted unfairly.
Following completion, both groups will complete post-test and follow-up assessments identical to the baseline questionnaires. Qualitative interviews will be conducted to explore participants' experiences with the intervention.
[Note - so as not to bias participants, specific information about the intervention will be withheld until the study is complete]
Тип исследования
Интервенционный
Регистрация (Оцененный)
150
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Mark Benson, MD
- Номер телефона: 608-263-1995
- Электронная почта: mb4@medicine.wisc.edu
Места учебы
-
-
Wisconsin
-
Madison, Wisconsin, Соединенные Штаты, 53705
- UW Health Digestive Health Center
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-
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
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- Men and women currently diagnosed with Irritable Bowel Syndrome (IBS) by a healthcare provider.
- Able to read and write in English.
- Willing to complete questionnaires and participate in either the intervention or control group.
- Capable of providing informed consent.
- Must be a UW Health patient or referred through UW Digestive Health Center.
Exclusion Criteria:
- Individuals with cognitive impairments or reading difficulties that would interfere with understanding study materials or completing assessments.
- Individuals unable to provide informed consent.
- Prior participation in a similar intervention study.
- Non-English speakers (since study materials are in English)
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: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Well-Being Intervention
|
The intervention will be once weekly over a 15-week period, lasting approximately one hour per session.
|
|
Активный компаратор: Waitlist Control (delayed Well-Being Intervention)
|
The intervention will be once weekly over a 15-week period, lasting approximately one hour per session.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Anger measured by PROMIS Anger Scale Score
Временное ограничение: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anger Scale is scored from 5-25 where higher scores indicates more anger.
|
Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
|
Anxiety measured by PROMIS Anxiety Scale Score
Временное ограничение: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
The PROMIS Anxiety Scale is scored from 7-35 where higher scores indicates more anxiety.
|
Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
|
Depression measured by IBS PROMIS Depression Scale Score
Временное ограничение: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
The IBS PROMIS Depression Scale is scored from 8-40 where higher scores indicates more depression.
|
Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
|
Fatigue measured by IBS Fatigue 8a Score
Временное ограничение: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
The IBS Fatigue 8a Scale is scored from 8-40 where higher scores indicates more fatigue.
|
Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
|
Sleep Disturbance measured by IBS Sleep Disturbance 8b
Временное ограничение: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
The IBS Sleep Disturbance 8b Scale is scored from 8-40 where higher scores indicates more sleep disturbance.
|
Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
|
Pain measured by Item 1b of the IBS Symptom Severity Scale
Временное ограничение: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
This item is scored from 0-100 where higher scores indicates increased pain.
|
Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
|
IBS Severity Score measured by IBS Symptom Severity Scale
Временное ограничение: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
The IBS Symptom Severity Scale is scored from 0-100 where higher scores indicates more severe IBS symptoms.
|
Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
|
Well-Being measured by a 30 item Inventory
Временное ограничение: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
The inventory is scored from 30-180 where higher scores indicates greater level of well-being.
|
Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
|
Self-esteem measured by Rosenberg Self Esteem Scale Score
Временное ограничение: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
The Rosenberg Self Esteem Scale is scored from 0-30 where higher scores indicates higher self esteem.
|
Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
|
Empathy measured by Empathy Questionnaire
Временное ограничение: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
The Empathy Questionnaire is scored from 0-64 where higher scores indicates higher empathy.
|
Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
|
Hope measured by Heart Hope Index Score
Временное ограничение: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
The Heart Hope Index is scored from 12-48 where higher scores indicates greater hope.
|
Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
|
Healthy Diet Pattern measured by an IBS Diet Survey
Временное ограничение: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
The Diet Survey is scored from 5-24 where higher scores indicate healthier diet pattern.
|
Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Mark Benson, MD, UW School of Medicine and Public Health
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 (Оцененный)
1 сентября 2026 г.
Первичное завершение (Оцененный)
1 августа 2027 г.
Завершение исследования (Оцененный)
1 августа 2027 г.
Даты регистрации исследования
Первый отправленный
13 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
13 мая 2026 г.
Первый опубликованный (Действительный)
20 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
14 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2025-1538
- SMPH/DOM/Gastroent and Hepato (Другой идентификатор: UW Madison)
- Protocol Approved 9/2/26 (Другой идентификатор: UW Madison)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
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. .