A Well-Being Intervention for People With IBS

Обзор

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.

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.

\[Note - so as not to bias participants, specific information about the intervention will be withheld until the study is complete\]

Вмешательства

• Поведенческое Well-Being Intervention
  The intervention will be once weekly over a 15-week period, lasting approximately one hour per session.

Первичные конечные точки

• Anger measured by PROMIS Anger Scale Score [Срок оценки: data collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group]
• Anxiety measured by PROMIS Anxiety Scale Score [Срок оценки: data collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group]
• Depression measured by IBS PROMIS Depression Scale Score [Срок оценки: data collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group]
• Fatigue measured by IBS Fatigue 8a Score [Срок оценки: data collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group]
• Sleep Disturbance measured by IBS Sleep Disturbance 8b [Срок оценки: data collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group]
• Pain measured by Item 1b of the IBS Symptom Severity Scale [Срок оценки: data collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group]
• IBS Severity Score measured by IBS Symptom Severity Scale [Срок оценки: data collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group]
• Well-Being measured by a 30 item Inventory [Срок оценки: data collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group]
• Self-esteem measured by Rosenberg Self Esteem Scale Score [Срок оценки: data collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group]
• Empathy measured by Empathy Questionnaire [Срок оценки: data collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UW Health Digestive Health Center — Madison

Идентификаторы

NCT: NCT07600047 · 2025-1538 · Protocol Approved 4/2/26 · SMPH/DOM/Gastroent and Hepato

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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