A Well-Being Intervention for People With IBS
9 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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]
Tipo de estudo
Intervencional
Inscrição (Estimado)
150
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Mark Benson, MD
- Número de telefone: 608-263-1995
- E-mail: mb4@medicine.wisc.edu
Locais de estudo
-
-
Wisconsin
-
Madison, Wisconsin, Estados Unidos, 53705
- UW Health Digestive Health Center
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Well-Being Intervention
|
The intervention will be once weekly over a 15-week period, lasting approximately one hour per session.
|
|
Comparador Ativo: Waitlist Control (delayed Well-Being Intervention)
|
The intervention will be once weekly over a 15-week period, lasting approximately one hour per session.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Anger measured by PROMIS Anger Scale Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Mark Benson, MD, UW School of Medicine and Public Health
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de agosto de 2027
Conclusão do estudo (Estimado)
1 de agosto de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
13 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de maio de 2026
Primeira postagem (Real)
20 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-1538
- SMPH/DOM/Gastroent and Hepato (Outro identificador: UW Madison)
- Protocol Approved 9/2/26 (Outro identificador: UW Madison)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .