A Well-Being Intervention for People With IBS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Anxiety measured by PROMIS Anxiety Scale Score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Well-Being Intervention
干预措施: Well-Being Intervention (Behavioral)
Waitlist Control (delayed Well-Being Intervention)
干预措施: Well-Being Intervention (Behavioral)
结局指标
主要结局
Anxiety measured by PROMIS Anxiety Scale Score
时间窗: 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
The PROMIS Anxiety Scale is scored from 7-35 where higher scores indicates more anxiety.
Depression measured by IBS PROMIS Depression Scale Score
时间窗: 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
The IBS PROMIS Depression Scale is scored from 8-40 where higher scores indicates more depression.
Fatigue measured by IBS Fatigue 8a Score
时间窗: 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
The IBS Fatigue 8a Scale is scored from 8-40 where higher scores indicates more fatigue.
Sleep Disturbance measured by IBS Sleep Disturbance 8b
时间窗: 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
The IBS Sleep Disturbance 8b Scale is scored from 8-40 where higher scores indicates more sleep disturbance.
Pain measured by Item 1b of the IBS Symptom Severity Scale
时间窗: 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
This item is scored from 0-100 where higher scores indicates increased pain.
IBS Severity Score measured by IBS Symptom Severity Scale
时间窗: 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
The IBS Symptom Severity Scale is scored from 0-100 where higher scores indicates more severe IBS symptoms.
Well-Being measured by a 30 item Inventory
时间窗: 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
The inventory is scored from 30-180 where higher scores indicates greater level of well-being.
Self-esteem measured by Rosenberg Self Esteem Scale Score
时间窗: 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
The Rosenberg Self Esteem Scale is scored from 0-30 where higher scores indicates higher self esteem.
Empathy measured by Empathy Questionnaire
时间窗: 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
The Empathy Questionnaire is scored from 0-64 where higher scores indicates higher empathy.
Hope measured by Heart Hope Index Score
时间窗: 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
The Heart Hope Index is scored from 12-48 where higher scores indicates greater hope.
Healthy Diet Pattern measured by an IBS Diet Survey
时间窗: 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
The Diet Survey is scored from 5-24 where higher scores indicate healthier diet pattern.
Anger measured by PROMIS Anger Scale Score
时间窗: 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
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anger Scale is scored from 5-25 where higher scores indicates more anger.
Anger measured by PROMIS Anger Scale Score
时间窗: 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.
Anxiety measured by PROMIS Anxiety Scale Score
时间窗: 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.
Depression measured by IBS PROMIS Depression Scale Score
时间窗: 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.
Fatigue measured by IBS Fatigue 8a Score
时间窗: 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.
Sleep Disturbance measured by IBS Sleep Disturbance 8b
时间窗: 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.
Pain measured by Item 1b of the IBS Symptom Severity Scale
时间窗: 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.
IBS Severity Score measured by IBS Symptom Severity Scale
时间窗: 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.
Well-Being measured by a 30 item Inventory
时间窗: 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.
Self-esteem measured by Rosenberg Self Esteem Scale Score
时间窗: 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.
Empathy measured by Empathy Questionnaire
时间窗: 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.
Hope measured by Heart Hope Index Score
时间窗: 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.
Healthy Diet Pattern measured by an IBS Diet Survey
时间窗: 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.
次要结局
未报告次要终点